Molecules / Glatiramer

Glatiramer API manufacturers

CAS 28704-27-0 Updated 9 July 2026
8
manufacturers with an active filing 6 of them hold a US DMF or a CEP
4
shortage records on file across 2 countries
125
finished-dose makers across 30 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for glatiramer, filing since 2012. 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
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02

Amneal

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

Holds one active US DMF for glatiramer, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.

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

Hybio Pharmaceutical

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

Holds one active US DMF for glatiramer, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Gland Pharma

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

Holds one active US DMF for glatiramer, filing since 2018. 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
View profile
05

Auro Peptides

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

Holds one active US DMF for glatiramer, filing since 2020. 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
06

Synthon

Netherlands
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for glatiramer. Its GMP is recognised in 14 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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07

Natco Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for glatiramer. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
08

Ambio

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

Holds one active US DMF for glatiramer, filing since 2012. 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

5 more manufacturers hold filings for glatiramer

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

Gland PharmaAuro PeptidesSynthonNatco PharmaAmbio
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Contract manufacturers (1)

Centurion Pharma Turkey

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

Finished-dose makers (11)

Viatris United States Teva Israel Ajenat Pharmaceuticals United States Italfarmaco Italy Pharmascience Canada Zentiva, k.s Czech Republic Biocon India Sanofi France Dankos Farma Indonesia Teva Pharmaceuticals Israel Laboratorios Bagó Argentina

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 glatiramer?

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

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Also on this molecule

Shortages 4 Recalls 3 Finished dose 11 Contract mfrs 1