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.

12 older run(s) hidden. Show all runs

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.

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

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

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
BatchStartNeedReleased
VX201-RAL-AF1-00110-181690ok
MB114-RAL-LY1-00110-202074ok
VX201-RAL-AF1-00210-221654ok
MB114-RAL-LY1-00210-252038ok
VX201-RAL-AF1-00310-2616320ok
VX201-RAL-AF1-00410-3016304ok
MB114-RAL-LY1-00310-3020288ok
VX201-RAL-AF1-00511-0316268ok
MB114-RAL-LY1-00411-0420252ok
VX201-RAL-AF1-00611-0716232ok
MB114-RAL-LY1-00511-0920216ok
VX201-RAL-AF1-00711-1116196ok
MB114-RAL-LY1-00611-1420460ok
VX201-RAL-AF1-00811-1516440ok
VX201-RAL-AF1-00911-1916424ok
MB114-RAL-LY1-00711-1920408ok
VX201-RAL-AF1-01011-2316388ok
MB114-RAL-LY1-00811-2420372ok
VX201-RAL-AF1-01111-2716352ok
MB114-RAL-LY1-00911-2920336ok
VX201-RAL-AF1-01212-0116316ok
MB114-RAL-LY1-01012-0420300ok
VX201-RAL-AF1-01312-0516280ok
VX201-RAL-AF1-01412-0916264ok
MB114-RAL-LY1-01112-0920248ok
VX201-RAL-AF1-01512-1316228ok
MB114-RAL-LY1-01212-1420212ok
Supplier evidence · MAT-MAN-PAR · MSN-0019

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

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/mannitolpharmaoffer.com/api-excipient-supplier/diuretics/mannitolwww.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-freedrug-dev.com/pfanstiehl-launches-cgmp-produced-parenteral-grade-
Material dossier · MAT-MAN-PAR · MSN-0019

Dossier: Mannitol, parenteral grade (low endotoxin)

2D structure of mannitol
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/propertpubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/6251/synonyms/JSOpubchem.ncbi.nlm.nih.gov/rest/pug_view/data/compound/6251/JSON?hpubchem.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.

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

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

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
BatchStartNeedReleased
VX201-RAL-AF1-00110-181690ok
MB114-RAL-LY1-00110-202074ok
VX201-RAL-AF1-00210-221654ok
MB114-RAL-LY1-00210-252038ok
VX201-RAL-AF1-00310-2616320ok
VX201-RAL-AF1-00410-3016304ok
MB114-RAL-LY1-00310-3020288ok
VX201-RAL-AF1-00511-0316268ok
MB114-RAL-LY1-00411-0420252ok
VX201-RAL-AF1-00611-0716232ok
MB114-RAL-LY1-00511-0920216ok
VX201-RAL-AF1-00711-1116196ok
MB114-RAL-LY1-00611-1420460ok
VX201-RAL-AF1-00811-1516440ok
VX201-RAL-AF1-00911-1916424ok
MB114-RAL-LY1-00711-1920408ok
VX201-RAL-AF1-01011-2316388ok
MB114-RAL-LY1-00811-2420372ok
VX201-RAL-AF1-01111-2716352ok
MB114-RAL-LY1-00911-2920336ok
VX201-RAL-AF1-01212-0116316ok
MB114-RAL-LY1-01012-0420300ok
VX201-RAL-AF1-01312-0516280ok
VX201-RAL-AF1-01412-0916264ok
MB114-RAL-LY1-01112-0920248ok
VX201-RAL-AF1-01512-1316228ok
MB114-RAL-LY1-01212-1420212ok
Supplier evidence · MAT-MAN-PAR · MSN-0018

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

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/mannitolpharmaoffer.com/api-excipient-supplier/diuretics/mannitolwww.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.

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

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
BatchStartNeedReleased
VX201-RAL-AF1-00110-181690ok
MB114-RAL-LY1-00110-202074ok
VX201-RAL-AF1-00210-221654ok
MB114-RAL-LY1-00210-252038ok
VX201-RAL-AF1-00310-2616320ok
VX201-RAL-AF1-00410-3016304ok
MB114-RAL-LY1-00310-3020288ok
VX201-RAL-AF1-00511-0316268ok
MB114-RAL-LY1-00411-0420252ok
VX201-RAL-AF1-00611-0716232ok
MB114-RAL-LY1-00511-0920216ok
VX201-RAL-AF1-00711-1116196ok
MB114-RAL-LY1-00611-1420180ok
VX201-RAL-AF1-00811-1516160ok
VX201-RAL-AF1-00911-1916144ok
MB114-RAL-LY1-00711-1920128ok
VX201-RAL-AF1-01011-2316388ok
MB114-RAL-LY1-00811-2420372ok
VX201-RAL-AF1-01111-2716352ok
MB114-RAL-LY1-00911-2920336ok
VX201-RAL-AF1-01212-0116316ok
MB114-RAL-LY1-01012-0420300ok
VX201-RAL-AF1-01312-0516280ok
VX201-RAL-AF1-01412-0916264ok
MB114-RAL-LY1-01112-0920248ok
VX201-RAL-AF1-01512-1316228ok
MB114-RAL-LY1-01212-1420212ok
QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0017

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

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.

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

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

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
BatchStartNeedReleased
VX201-RAL-AF1-00110-181690ok
MB114-RAL-LY1-00110-202074ok
VX201-RAL-AF1-00210-221654ok
MB114-RAL-LY1-00210-252038ok
VX201-RAL-AF1-00310-2616320ok
VX201-RAL-AF1-00410-3016304ok
MB114-RAL-LY1-00310-3020288ok
VX201-RAL-AF1-00511-0316268ok
MB114-RAL-LY1-00411-0420252ok
VX201-RAL-AF1-00611-0716232ok
MB114-RAL-LY1-00511-0920216ok
VX201-RAL-AF1-00711-1116196ok
MB114-RAL-LY1-00611-1420460ok
VX201-RAL-AF1-00811-1516440ok
VX201-RAL-AF1-00911-1916424ok
MB114-RAL-LY1-00711-1920408ok
VX201-RAL-AF1-01011-2316388ok
MB114-RAL-LY1-00811-2420372ok
VX201-RAL-AF1-01111-2716352ok
MB114-RAL-LY1-00911-2920336ok
VX201-RAL-AF1-01212-0116316ok
MB114-RAL-LY1-01012-0420300ok
VX201-RAL-AF1-01312-0516280ok
VX201-RAL-AF1-01412-0916264ok
MB114-RAL-LY1-01112-0920248ok
VX201-RAL-AF1-01512-1316228ok
MB114-RAL-LY1-01212-1420212ok
Supplier evidence · MAT-MAN-PAR · MSN-0016

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

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/mannitolwww.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-freepharmaoffer.com/api-excipient-supplier/diuretics/mannitoldrug-dev.com/pfanstiehl-launches-cgmp-produced-parenteral-grade-