Glatiramer API Manufacturers and Suppliers

Compare the 7 manufacturers holding an active US Drug Master File for Glatiramer API, with DMF numbers and filing years from the FDA's quarterly DMF list.

Directory listing last reviewed October 2026.

Glatiramer API manufacturers with a US Drug Master File

7 manufacturers hold an active Type II Drug Master File for GlatiramerAPI, taken from the FDA's quarterly DMF list; 4 of them are listed in this directory. A DMF lets a drug applicant reference the maker's manufacturing data. It is not an FDA approval. Check each manufacturer against the FDA import alert lists before ordering.

ManufacturerLocationUS DMFFiled
Dr. Reddy's LaboratoriesIndia258552012
Hybio PharmaceuticalChina289892014
Auro PeptidesIndia (Hyderabad)354932020
Alembic PharmaceuticalsIndia (Vadodara)446552026

Other Glatiramer DMF holders

Not yet listed in this directory, so we have not reviewed them. Names as printed in the FDA DMF list.

DMF holderUS DMFFiled
Ambio Inc264892012
Amneal Pharmaceuticals LLC277232013
Gland Pharma Ltd330922018

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