Evidence board

What the agent looked at

Chemical dossiers, production-line feasibility, QA packets and supplier evidence gathered during missions. Corvane Biologics is fictional and its inventory, schedules and suppliers are synthetic; PubChem and web evidence are live.

Run MSN-0019 · 2026-11-13 13:00 UTC · 5 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0019

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-13 13:06 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-121), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-121
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail sourcing: "only SUP-004's quote lands by the need-by date of 2026-10-17 ... SUP-006 (Q-0261) at 9 days lands ~2026-10-26" (the other three quotes "do not land in time"); sourcing: "quote Q-0262, at $22.7489/kg landed USD ($13,239.87 total for 582 kg)"

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0019

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-13 13:04 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0019

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-13 13:04 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0019

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-13 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Pharmaoffer (directory listing) directory
Compare 21 Mannitol API suppliers from China, India and Japan. Check GMP, CEP and US DMF status and request a quote directly - free on Pharmaoffer. ... Mannitol (Diuretics, CAS 69-65-8) is offered by 21 suppliers on Pharmaoffer - 14 produce
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Drug Dev supplier_site
Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 ... Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
pharma excipients (directory listing) directory
Low-endoxin carbohydrates, polysaccharides and oligosaccharides incl. Trehalose, Sucralose, Mannitol, Mannose, Maltose for injectable formulations. ... Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up develop
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol pharmaoffer.com/api-excipient-supplier/diuretics/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free drug-dev.com/pfanstiehl-launches-cgmp-produced-parenteral-grade-

Material dossier · MAT-MAN-PAR · MSN-0019

Dossier: Mannitol, parenteral grade (low endotoxin)

2026-11-13 13:00 UTC

PubChem CID: 6251
Formula: C6H14O6
Mol. weight: 182.17
CAS: 69-65-8, 87-78-5, 133-43-7
XLogP: -3.1
GHS: Not Classified
IUPAC: (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol

Our spec

Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Storage: 15-25 C, dry, protected from light
Shelf life: 1095 days
Sourcing: spec_led
QC release: 7 days

Approved suppliers

Kestrel Polyols SUP-004 · released_for_use · CEP
Brightwater Sugars SUP-003 · released_for_use
Halvard Fine Chemicals SUP-005 · quality_approved · CEP
Corrib Pharma Supply SUP-006 · quality_approved · DMF, CEP

Sourcespubchem.ncbi.nlm.nih.gov/rest/pug/compound/name/mannitol/propert pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/6251/synonyms/JSO pubchem.ncbi.nlm.nih.gov/rest/pug_view/data/compound/6251/JSON?h pubchem.ncbi.nlm.nih.gov/compound/6251

Run MSN-0018 · 2026-11-12 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 3 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0018

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 3 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-12 13:06 UTC

Auto-approved; 3 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-120), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 3 usable quotes of 3 received on RFQ-120
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail recommended_supplier_id: SUP-006; the fastest supplier is recommended: SUP-006 (Corrib Pharma Supply), quote Q-0258, 9-day expedited lead time, $29.3592/kg landed ($17,087.06 total for 582 kg); None of the quotes land by the need-by date of 2026-10-17 (today). The earliest possible landing is SUP-006's 9-day expedited lead time, landing 2026-10-26 — 9 days late.

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0018

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-12 13:05 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0018

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-12 13:05 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0018

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-12 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... It is also compatible with a wide range of active pharmaceutical ingredients (APIs) and
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Pharmaoffer (directory listing) directory
Compare 21 Mannitol API suppliers from China, India and Japan. Check GMP, CEP and US DMF status and request a quote directly - free on Pharmaoffer. ... Quality considerations for API sourcing include control of particle size distribution fo
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharma Excipients (directory listing) directory
PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. As an API it serves as an ... PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. Get a sample!
Roquette supplier_site
Mannitol pyrogen free used as API as osmotic diuretic agent to reduce intracranial and introcular pressure\nUsed as Excipient as isotonic agent in In1 ... Large Volume Parenterals (LVP) Rx Injectable · APIs · Osmotic diuretic agent · Excipi

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP pharmaceutical excipient / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol pharmaoffer.com/api-excipient-supplier/diuretics/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmaexcipients.com/product/pearlitol-pf-mannitol-pfg/www.roquette.com/health-pharma/injectable-dialysis-specialty-api

Run MSN-0017 · 2026-11-11 13:03 UTC · 3 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0017

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-11 13:04 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-119), 28 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 28 d + QC release 7 d = 35 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-119
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 35)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail sourcing recommended_supplier_id "SUP-006" and "SUP-006 is the only supplier whose quote lands in time, so it is recommended" — facts select SUP-004 (Kestrel Polyols), qualification_state released_for_use; SUP-006 is not shown as released_for_use; "Only SUP-006 (Corrib Pharma Supply), quote Q-0253, can land by the need-by date ... 24.18 EUR/kg with a 9-day expedited lead time, normalizing to $28.8253/kg landed ($16,776.30 total for 582 kg)" — facts show SUP-004 at $20.3111/kg landed, 28-day lead, qty 280, value_usd 5,687; "The other three quotes do not meet the deadline: SUP-004 (Q-0256, $20.3111/kg landed, 28-day lead) had an expedite option offered but not accepted/formalized" — facts select SUP-004 and the lands_in_time check passes with its 28-day lead; "p_in_time = 0 for all suppliers at the need-by date (days_available = 0)" — facts show days_available: 35

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0017

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-11 13:03 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-14, released 2026-11-21

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	180	ok
VX201-RAL-AF1-008	11-15	16	160	ok
VX201-RAL-AF1-009	11-19	16	144	ok
MB114-RAL-LY1-007	11-19	20	128	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0017

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-11 13:03 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Run MSN-0016 · 2026-11-10 13:01 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0016

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-10 13:03 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-118), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-118
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail recommended_supplier_id: SUP-006 / Recommendation: award to SUP-006 (Corrib Pharma Supply), quote Q-0252 — facts select SUP-004 (Kestrel Polyols), released_for_use; SUP-006 is not shown as released_for_use.; Only SUP-006 (Q-0252, 24.93 EUR/kg, 29.6596 USD/kg landed, 17,261.86 USD total) can land by the need-by date of 2026-10-17, via its 9-day expedited lead time — contradicted by facts: SUP-004 (19-day lead + 7-day QC = 26 days) lands within the 35 days available (lands_in_time pass).; The other three quotes do not meet the need-by date: SUP-004 (Q-0249, 21.8625 USD/kg, 19-day lead time, expedite not available) — contradicted; SUP-004 is the plan's released_for_use supplier and meets the need-by date.; three negotiations were already in an accepted state and the expedite could not be raised for them, while SUP-006's negotiator secured an expedite at no premium — negotiation outcomes not shown in the facts.

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0016

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-10 13:02 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0016

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-10 13:02 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0016

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-10 13:01 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Pharmaoffer (directory listing) directory
CAS №: 69-65-8 | Diuretics | Find certified Mannitol API suppliers. Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Quality considerations for API sourcing include contr
Drug Dev supplier_site
Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 ... Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free pharmaoffer.com/api-excipient-supplier/diuretics/mannitol drug-dev.com/pfanstiehl-launches-cgmp-produced-parenteral-grade-

Run MSN-0015 · 2026-11-08 13:01 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0015

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-08 13:09 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-117), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-117
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail Sourcing recommends award to SUP-003 (Brightwater Sugars), quote Q-0248, at 21.0468 USD/kg landed (12,249.21 USD total for 582 kg), delivery 2026-10-17 — this contradicts the facts, which show the purchase is from SUP-004 (Kestrel Polyols, released_for_use), 280 kg at 22.7139 USD/kg = 6,360 USD, 19-day lead time, arrival 2026-11-05; SUP-003 is not shown as released_for_use or quality_approved.

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0015

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-08 13:05 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0015

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-08 13:05 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Supplier evidence · MAT-MAN-PAR · MSN-0015

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-08 13:01 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... It is also compatible with a wide range of active pharmaceutical ingredients (APIs) and
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharma Excipients (directory listing) directory
PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. As an API it serves as an ... PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. Get a sample!
Pharmaoffer (directory listing) directory
CAS №: 69-65-8 | Diuretics | Find certified Mannitol API suppliers. Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Quality considerations for API sourcing include contr
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
Celluloseankit supplier_site
Ankit Pulps & Boards is leading manufacturer of Mannitol Excipient for pharmaceutical and food industries. Explore our offerings for your specific applications.
Roquette supplier_site
High purity mannitol · It can take several minutes for us to prepare your files, leave us your email and we'll send you a link so you can download them when they're ready ... Low endotoxin · For application in BioPharma · High purity mannit
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP pharmaceutical excipient manufacturer / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmaexcipients.com/product/pearlitol-pf-mannitol-pfg/pharmaoffer.com/api-excipient-supplier/diuretics/mannitol www.clyzo.com/excipient/mannitol/d--mannitol-low-endotoxin--ph-e

Run MSN-0014 · 2026-11-07 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0014

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-07 13:06 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-116), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-116
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail sourcing: 'total landed 12,723.95 USD for 582 kg' from SUP-004 quote Q-0243 contradicts the plan, which shows a 280 kg purchase from SUP-004 valued at 6,122 USD; 582 kg is the total need covered by 302 kg transfer + 280 kg purchase

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0014

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-07 13:05 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0014

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-07 13:05 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Supplier evidence · MAT-MAN-PAR · MSN-0014

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-07 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.pharmaexcipients.com/product/d-mannitol-emprove-expert/www.prnewswire.com/news-releases/pfanstiehl-launches-cgmp-produc

Run MSN-0013 · 2026-11-05 13:03 UTC · 3 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0013

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-05 13:08 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-115), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-115
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail Sourcing: "total 12,723.95 USD" for the SUP-004 quote/purchase (implied 582 kg) — contradicts the plan, which shows a 280 kg purchase from SUP-004 valued at 6,122 USD (the remaining 302 kg comes from the SITE-COR transfer).; Sourcing: "Found 4 approved suppliers (SUP-003 ... released_for_use, SUP-005 ... quality_approved, SUP-006 ... quality_approved)" — the facts only establish SUP-004 as released_for_use (qa_packet established_supplier_ids: ["SUP-004"]); the approval status of SUP-003/SUP-005/SUP-006 is not shown, so declaring them approved is ungrounded.; Sourcing: "Only SUP-004's quote ... meets the need-by date ... supplier confirms stock available for immediate shipment to meet 2026-10-17" — contradicts the 19-day lead time and 2026-11-05 arrival, which is after the 2026-10-17 need-by date (the transfer claim itself notes a timing shortfall).

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0013

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-05 13:03 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0013

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-05 13:03 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Run MSN-0012 · 2026-11-01 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0012

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-01 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-114), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-114
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail price_inventory recommends "transfer" at unit price 18.58; total 5,611.16 for the 302 kg; external resale would net 12.08/kg after a 35% expiry discount; recommended_supplier_id":"SUP-006"; Per instructions, since none lands in time, I recommend the fastest supplier.; SUP-006 ... with a landed cost of 29.6596 USD/kg (total 17,261.86 USD for 582 kg); SUP-006 is also the supplier ranked highest by supplier_reliability for this need; SUP-003 (Brightwater Sugars) Q-0236 at 20.9172 USD/kg, 37 days; SUP-005 (Halvard Fine Chemicals) Q-0234 at 26.3021 USD/kg, 31 days

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0012

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-01 13:02 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0012

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-11-01 13:02 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Supplier evidence · MAT-MAN-PAR · MSN-0012

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-01 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Sigmaaldrich supplier_site
D(-)-Mannitol EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP CAS Number: 69-65-8; Synonyms: D-Mannitol,Mannite; Linear Formula: HOCH2(CHOH)4CH2OH at Sigma-Aldrich ... Mannitol is a sugar alcohol which is used widely in biomolecule formulations
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar
Biospace supplier_site
CHICAGO, Dec. 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 compliant conditions. "Mannitol is a tried and true p

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.sigmaaldrich.com/US/en/product/mm/137162 www.pharmaexcipients.com/product/d-mannitol-emprove-expert/

Run MSN-0011 · 2026-10-31 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0011

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

2026-10-31 13:01 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-113), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-113
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded pass claims match recomputed facts

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0011

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-31 13:01 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0011

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-31 13:01 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0011

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-31 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... It is also compatible with a wide range of active pharmaceutical ingredients (APIs) and
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharma Excipients (directory listing) directory
PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. As an API it serves as an ... PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. Get a sample!
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
Roquette supplier_site
Mannitol pyrogen free used as API as osmotic diuretic agent to reduce intracranial and introcular pressure\nUsed as Excipient as isotonic agent in In1 ... Large Volume Parenterals (LVP) Rx Injectable · APIs · Osmotic diuretic agent · Excipi
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP pharmaceutical excipient / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmaexcipients.com/product/pearlitol-pf-mannitol-pfg/www.prnewswire.com/news-releases/pfanstiehl-launches-cgmp-produc www.roquette.com/health-pharma/injectable-dialysis-specialty-api

Run MSN-0010 · 2026-10-30 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0010

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-10-30 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-112), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-112
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail No negotiated quote lands by the need-by date of 2026-10-17 (today).; Per instructions, since none lands in time, I recommend the fastest supplier: SUP-006 (Corrib Pharma Supply) at 9 days lead time (landing ~2026-10-26)

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0010

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-30 13:01 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0010

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-30 13:01 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0010

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-30 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Sigmaaldrich supplier_site
D(-)-Mannitol EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP CAS Number: 69-65-8; Synonyms: D-Mannitol,Mannite; Linear Formula: HOCH2(CHOH)4CH2OH at Sigma-Aldrich ... Mannitol is a sugar alcohol which is used widely in biomolecule formulations
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.sigmaaldrich.com/US/en/product/mm/137162 www.pharmaexcipients.com/product/d-mannitol-emprove-expert/

Run MSN-0009 · 2026-10-28 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0009

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-10-28 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-111), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-111
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail Value moved (price_inventory): 302 kg at standard unit price 18.58 = 5,611.16; transfer is recommended over external resale (12.08/kg after a 35% expiry discount).; recommended_supplier_id":"SUP-006","rationale":"No quote lands by the need-by date of 2026-10-17 (today); all four negotiated quotes have positive lead times (9–37 days). Per instructions, since none lands in time, I recommend the fastest supplier. SUP-006 (Corrib Pharma Supply) quotes 9 days lead time, the fastest of the four, with a landed cost of 28.2691 USD/kg (total 16,452.59 USD for 582 kg).

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0009

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-28 13:02 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0009

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-28 13:02 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0009

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-28 13:00 UTC

discovery_candidate (not approved)

Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
Roquette supplier_site · page claims: US DMF, CEP, low endotoxin
High purity mannitol · It can take several minutes for us to prepare your files, leave us your email and we'll send you a link so you can download them when they're ready ... Low endotoxin · For application in BioPharma · High purity mannit
Bshingredients supplier_site
Buy food-grade 99% D-Mannitol powder in bulk. White crystalline low-calorie sweetener for confectionery, tablets, beverages, and food formulations. ... A typical endotoxin limit may be 0.08 EU/mg or lower, depending on the finished product
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
Dcfinechemicals supplier_site
Request more information · Do you have any questions? Get in touch and we’ll answer them
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourceswww.pharmacompass.com/manufacturers-suppliers-exporters/mannitol pfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/mannitol/cep-coa-dmf-fda-www.roquette.com/health-pharma/biologics-product-catalog/pearlit www.bshingredients.com/d-mannitol-powder/

Run MSN-0008 · 2026-10-25 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0008

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-10-25 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-110), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-110
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail "recommended_supplier_id":"SUP-006"; "I recommend the fastest quote: SUP-006 (Corrib Pharma Supply) at 9 days lead time, landed $29.1034/kg ($16,938.16 total for 582 kg, quote Q-0219, CIP, FX 1.08)."; "SUP-006 is also the supplier ranked highest by supplier_reliability for this need (risk-adjusted cost basis)."

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0008

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-25 13:02 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0008

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-25 13:02 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Supplier evidence · MAT-MAN-PAR · MSN-0008

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-25 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol (USP) API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol (USP) API with Drug Master Files (DMF), CEP/COS, Japanese D
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer
Dcfinechemicals supplier_site
Request more information · Do you have any questions? Get in touch and we’ll answer them

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/mannitol/cep-coa-dmf-fda-www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.clyzo.com/excipient/mannitol/d--mannitol-low-endotoxin--ph-e

Run MSN-0007 · 2026-10-24 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0007

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

2026-10-24 13:01 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-109), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-109
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded pass claims match recomputed facts

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0007

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-24 13:01 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0007

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-24 13:01 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0007

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-24 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol (USP) API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol (USP) API with Drug Master Files (DMF), CEP/COS, Japanese D
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/mannitol/cep-coa-dmf-fda-www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.pharmaexcipients.com/product/d-mannitol-emprove-expert/

Run MSN-0006 · 2026-10-23 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0006

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-10-23 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-108), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-108
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail Recommended SUP-003 (Brightwater Sugars) for RFQ-108; SUP-003 = $21.738/kg (total $12,651.49, 37-day expedited lead time, meets need-by date per negotiator); SUP-003 is the lowest landed cost among the three quotes that land by the need-by date.; SUP-003 confirmed expedited delivery meets the need-by date.

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0006

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-23 13:01 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0006

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-23 13:01 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Supplier evidence · MAT-MAN-PAR · MSN-0006

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-10-23 13:00 UTC

discovery_candidate (not approved)

Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of D-(-)-Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of D-(-)-Mannitol API with Drug Master Files (DMF), CEP/COS, Japanese D
Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmaoffer (directory listing) directory
Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
Bshingredients supplier_site
Buy food-grade 99% D-Mannitol powder in bulk. White crystalline low-calorie sweetener for confectionery, tablets, beverages, and food formulations. ... A typical endotoxin limit may be 0.08 EU/mg or lower, depending on the finished product
Pharma Excipients (directory listing) directory
PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. As an API it serves as an ... PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. Get a sample!
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Dcfinechemicals supplier_site
Request more information · Do you have any questions? Get in touch and we’ll answer them

Queries: Mannitol parenteral grade low endotoxin excipient supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourceswww.pharmacompass.com/manufacturers-suppliers-exporters/d-mannit pfanstiehl.com/en/high-purity-ingredients/mannitol/www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/mannitol/cep-coa-dmf-fda-www.bshingredients.com/d-mannitol-powder/www.pharmaexcipients.com/product/pearlitol-pf-mannitol-pfg/

Run MSN-0005 · 2026-10-22 13:01 UTC · 3 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0005

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-10-22 13:02 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-107), 19 days + 7 days QC

Checks

covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
qualified_only pass Kestrel Polyols is released_for_use
comparable_quotes pass 4 usable quotes of 4 received on RFQ-107
batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
grounded fail recommended_supplier_id":"SUP-003"; "582 kg of MAT-MAN-PAR at $21.1224/kg landed USD ($12,293.21 total), 37-day expedited lead time, meets the 2026-10-17 need-by date."; "This is the lowest landed cost among the three quotes that land by the need-by date (SUP-004 at $21.8625/kg and SUP-006 at $28.2802/kg are higher; SUP-005 at $26.1357/kg does not meet the need-by date)."

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0005

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-22 13:01 UTC

QC release: 7 days after arrival
Transfer release: 2 days (receipt verification)
Change control: not required
Supplier: SUP-004 · released_for_use
Cold chain: no
Storage: 15-25 C, dry, protected from light
Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Endotoxin: low

Documents required

Certificate of Analysis (CoA)
Certificate of Conformance (CoC)
CEP reference (SUP-004)
Inter-site transfer record with donor-site QA release status

Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0005

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

2026-10-22 13:01 UTC

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now: 90 kg
Horizon: 60 days from 2026-10-17

Lines

LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A

Inbound

transfer 302 kg: arrives 2026-10-24, released 2026-10-26
purchase 280 kg: arrives 2026-11-05, released 2026-11-12

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Other evidence

Lookups outside a mission

Supplier evidence · MAT-MAN-PAR

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-11 13:00 UTC

discovery_candidate (not approved)

Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
Pharmaoffer (directory listing) directory
Compare 21 Mannitol API suppliers from China, India and Japan. Check GMP, CEP and US DMF status and request a quote directly - free on Pharmaoffer. ... Mannitol (Diuretics, CAS 69-65-8) is offered by 21 suppliers on Pharmaoffer - 14 produce
Roquette supplier_site
PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
Pharma Excipients (directory listing) directory
Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol www.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/diuretics/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free www.pharmaexcipients.com/product/d-mannitol-emprove-expert/