Molecules / Heparin / United States

Heparin API manufacturers in United States

CAS 9041-08-1 Updated 9 July 2026
10
United States-based manufacturers with an active filing of 24 worldwide
Showing 5 of 10 United States-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked United States-based API manufacturers

01

Pfizer

United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for heparin, filing since 1976. Its 2019 FDA inspection closed as NAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

International Medication Systems

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

Holds one active US DMF for heparin, filing since 2012. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Biochem Sioux City

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

Holds one active US DMF for heparin, filing since 1985. Its 2021 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

5 more manufacturers in United States hold filings for heparin

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

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How this list is built

This page filters the worldwide Heparin manufacturer list to companies based in United States. 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. Read the full method.

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