Molecules / Fondaparinux

Fondaparinux API manufacturers

CAS 104993-28-4 ATC B01AX05 Updated 9 July 2026
14
manufacturers with an active filing 12 of them hold a US DMF or a CEP
2
shortage records on file across 2 countries
65
finished-dose makers across 30 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for fondaparinux, filing since 2009. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Jiangsu Hengrui Pharmaceuticals

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

Holds one active US DMF for fondaparinux, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Apitoria Pharma

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

Holds one active US DMF for fondaparinux, filing since 2014. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Wisdom Pharmaceutical

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

Holds one active US DMF for fondaparinux, filing since 2022. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Formosa Laboratories

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

Holds one active US DMF for fondaparinux, filing since 2013. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

ScinoPharm Taiwan

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

Holds one active US DMF for fondaparinux, filing since 2013. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for fondaparinux, filing since 2014. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Aspen Notre Dame De Bondeville

France
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for fondaparinux. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
09

BrightGene Bio-Medical Technology

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

Holds 2 active US DMFs for fondaparinux, filing since 2016. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Aspen Oss

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

Holds one active US DMF for fondaparinux, filing since 2014.

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
11

Newland Pharmaceutical

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

Holds one active US DMF for fondaparinux, filing since 2025.

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
12

Shanghai Acana Pharmatech

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

Holds one active US DMF for fondaparinux, filing since 2013.

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
13

Sichuan Aupone Pharmaceutical

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

Holds one active US DMF for fondaparinux, filing since 2023.

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
14

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fondaparinux. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

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

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