Molecules / Protamine

Protamine API manufacturers

CAS 9009-65-8 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
24
shortage records on file across 4 countries
93
finished-dose makers across 36 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gland Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for protamine, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Yuki Gosei Kogyo

Japan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for protamine, filing since 2000. Its 2026 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Alps Pharmaceutical Ind

Japan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for protamine, filing since 2007.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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04

Amphastar Nanjing

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for protamine, filing since 2016.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for protamine

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Amphastar NanjingBeijing Scrianen Pharmaceutical
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Contract manufacturers (3)

Yuki Gosei Kogyo Japan Qingdao Kangyuan Pharmaceutical China Onko İlaç Sanayi̇ Veti̇caret A.Ş Turkey

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (13)

Fresenius Kabi Ab Sweden HIKMA ITALIA Italy Viatris United States LEO Pharma A/S Denmark Cipla India Laboratorios Solkotal Argentina Lupin India Eris Lifesciences India Medipharm Tunisia Regenix Biosciences Limited, Old India Caplin Point Laboratories India Lilly Spain M/s. Eris India

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes protamine?

Ask Fred which manufacturers are on record for protamine and what filings they hold.

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Also on this molecule

Shortages 24 Recalls 4 Finished dose 13 Contract mfrs 3