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
Etelcalcetide API manufacturers
Etelcalcetide is a calcimimetic peptide for secondary hyperparathyroidism (Parsabiv).
4 listed companies hold an active US Type II Drug Master File for Etelcalcetide API, based in India (3), China (1). 4 have a regulator record of GMP manufacturing, and 1 carries an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Etelcalcetide API DMF holders (4)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
MSN Life Sciences Private Ltd (MSN Group)
HighHyderabad, India
GMP
Hyderabad-based MSN Group entity holding US DMFs for 11 peptide APIs, including semaglutide and tirzepatide. MSN runs 27 plants in India, the USA and Indonesia.
- Model
- CDMO
- Manufacturer?
- Yes
Hybio Pharmaceutical
HighShenzhen, China
GMP
Chinese peptide drug manufacturer producing APIs and finished products.
- Model
- Manufacturer
- Manufacturer?
- Yes
USV Private Limited
LowMumbai, India
GMP
Mumbai drug maker with its own API and formulation plants in India. Holds US DMFs for 3 peptide APIs. Received an FDA CGMP warning letter in November 2026.
Notice: open regulatory issue
- 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)
- Glatiramer API manufacturers (6)
- Calcitonin API manufacturers (5)
- Carfilzomib API manufacturers (5)
- Caspofungin API manufacturers (5)
- Exenatide API manufacturers (5)
- Micafungin API manufacturers (5)
- Plecanatide API manufacturers (5)
- Sincalide API manufacturers (4)
- Glucagon API manufacturers (3)
Related
Frequently asked questions
Who manufactures Etelcalcetide API?
Companies holding active US DMFs for Etelcalcetide include Auro Peptides Ltd, MSN Life Sciences Private Ltd (MSN Group), Hybio Pharmaceutical and USV Private Limited. Other manufacturers may supply it without a US DMF.
Where are Etelcalcetide API manufacturers based?
Among listed DMF holders: India (3), China (1).
Do any Etelcalcetide API holders have FDA warning letters?
USV Private Limited has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
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.