Molecules / Enoxaparin

Enoxaparin API manufacturers

CAS 9005-49-6 Updated 9 July 2026
13
manufacturers with an active filing 13 of them hold a US DMF or a CEP
58
shortage records on file across 6 countries
239
finished-dose makers across 38 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Nanjing King-Friend Biochemical Pharmaceutical

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

Holds one active US DMF for enoxaparin, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
5 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 one active US DMF for enoxaparin, filing since 2012. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Shenzhen Techdow Pharmaceutical

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

Holds 2 active US DMFs for enoxaparin, filing since 2013. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Gland Pharma

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

Holds one valid CEP for enoxaparin, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced EDQM certificate database
View profile
06
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for enoxaparin, filing since 2017. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Hubei Enoray Biopharmaceutical

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

Holds one active US DMF for enoxaparin, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Apitoria Pharma

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

Holds one active US DMF for enoxaparin, filing since 2025. 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
09

Celsus Laboratories

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

Holds one active US DMF for enoxaparin, filing since 2008.

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
10

Hangzhou Jiuyuan Gene Engineering

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

Holds one active US DMF for enoxaparin, filing since 2011. Its GMP is recognised in 1 market.

US DMF
1 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
11

Deft Organics

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

Holds one active US DMF for enoxaparin, 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

Contract manufacturers (5)

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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