Alembic Pharmaceuticals Ltd
HighVadodara, India
GMP
Vadodara drug maker, dating to 1907, with three API plants and six formulation plants. Holds US DMFs for 6 peptide APIs, including glatiramer and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Glatiramer API manufacturers
Glatiramer is a random peptide polymer used in multiple sclerosis (Copaxone).
6 listed companies hold an active US Type II Drug Master File for Glatiramer API, based in India (3), United States (2), China (1). 5 have a regulator record of GMP manufacturing.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Glatiramer API DMF holders (6)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Auro Peptides Ltd
HighSangareddy (near Hyderabad), India
GMP
Peptide API subsidiary of Aurobindo Pharma with a plant near Hyderabad. Makes generic peptide APIs and runs GMP contract projects from mg to kg scale.
- Model
- CDMO
- Manufacturer?
- Yes
Gland Pharma Ltd
HighHyderabad, India
GMP
Hyderabad injectables CDMO founded 1978, promoted by Fosun Pharma; FDA-inspected sites; US DMF for glatiramer acetate.
- Model
- CDMO
- Manufacturer?
- Yes
AmbioPharm
HighNorth Augusta, South Carolina, USA
GMPCOA
US peptide API CDMO with facilities in the US and China.
- Model
- CDMO
- Manufacturer?
- Yes
Hybio Pharmaceutical
HighShenzhen, China
GMP
Chinese peptide drug manufacturer producing APIs and finished products.
- Model
- Manufacturer
- Manufacturer?
- Yes
Amneal Pharmaceuticals LLC
HighBridgewater, NJ, USA
US generics, specialty and biosimilars company with operations in the US, India and Ireland; US DMF for glatiramer acetate.
- Model
- Manufacturer
- Manufacturer?
- Yes
Other peptide APIs
- Semaglutide API manufacturers (45)
- Tirzepatide API manufacturers (28)
- Liraglutide API manufacturers (20)
- Octreotide API manufacturers (20)
- Icatibant API manufacturers (13)
- Leuprolide API manufacturers (12)
- Cetrorelix API manufacturers (11)
- Teriparatide API manufacturers (11)
- Desmopressin API manufacturers (10)
- Retatrutide API manufacturers (10)
- Lanreotide API manufacturers (9)
- Linaclotide API manufacturers (9)
- Bivalirudin API manufacturers (8)
- Difelikefalin API manufacturers (8)
- Eptifibatide API manufacturers (8)
- Ganirelix API manufacturers (8)
- Bortezomib API manufacturers (7)
- Degarelix API manufacturers (7)
- Oxytocin API manufacturers (7)
- Vasopressin API manufacturers (7)
- Calcitonin API manufacturers (5)
- Carfilzomib API manufacturers (5)
- Caspofungin API manufacturers (5)
- Exenatide API manufacturers (5)
- Micafungin API manufacturers (5)
- Plecanatide API manufacturers (5)
- Etelcalcetide API manufacturers (4)
- Sincalide API manufacturers (4)
- Glucagon API manufacturers (3)
Related
Frequently asked questions
Who manufactures Glatiramer API?
Companies holding active US DMFs for Glatiramer include Alembic Pharmaceuticals Ltd, Auro Peptides Ltd, Gland Pharma Ltd, AmbioPharm, Hybio Pharmaceutical and Amneal Pharmaceuticals LLC. Other manufacturers may supply it without a US DMF.
Where are Glatiramer API manufacturers based?
Among listed DMF holders: India (3), United States (2), China (1).
Does a DMF mean the API is FDA approved?
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.