PolyPeptide Group
HighBaar, Switzerland (sites in SE, BE, FR, US, IN)
GMPCOA
Peptide-focused CDMO running GMP manufacturing sites on three continents.
- Model
- CDMO
- Manufacturer?
- Yes
Terlipressin API manufacturers
Terlipressin is a vasopressin analogue used in hepatorenal syndrome (Terlivaz).
3 listed companies hold an active US Type II Drug Master File for Terlipressin API, based in Switzerland (1), India (1), China (1). 3 have a regulator record of GMP manufacturing, and 2 carry an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Terlipressin API DMF holders (3)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Cipla Ltd
LowMumbai, India
GMP
Mumbai drug maker incorporated in 1935 with plants in India and the USA. Holds US DMFs for difelikefalin, icatibant and terlipressin. Pithampur FDA warning letter still open.
Notice: open regulatory issue
- Model
- Manufacturer
- Manufacturer?
- Yes
Harbin Jixianglong Biotech Co., Ltd.
LowHarbin, China
GMP
Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.
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)
- Etelcalcetide API manufacturers (4)
- Sincalide API manufacturers (4)
- Glucagon API manufacturers (3)
Related
Frequently asked questions
Who manufactures Terlipressin API?
Companies holding active US DMFs for Terlipressin include PolyPeptide Group, Cipla Ltd and Harbin Jixianglong Biotech Co., Ltd.. Other manufacturers may supply it without a US DMF.
Where are Terlipressin API manufacturers based?
Among listed DMF holders: Switzerland (1), India (1), China (1).
Do any Terlipressin API holders have FDA warning letters?
Cipla Ltd and Harbin Jixianglong Biotech Co., Ltd. have 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.