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
Icatibant API manufacturers
Icatibant is a bradykinin B2 receptor antagonist for hereditary angioedema attacks (Firazyr).
13 listed companies hold an active US Type II Drug Master File for Icatibant API, based in India (7), Spain (1), Netherlands (1), United States (1), Switzerland (1), Italy (1), China (1). 11 have a regulator record of GMP manufacturing, and 3 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.
Icatibant API DMF holders (13)
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
BCN Peptides SA
HighSant Quinti de Mediona (Barcelona), Spain
GMPISO
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
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
TAPI NL B.V. (TAPI)
HighAmsterdam, Netherlands
GMP
Dutch holding entity of TAPI, Teva's API and CDMO business, with peptide development and GMP production across a global plant network. Holds US DMFs for 9 peptide APIs.
- 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
Bachem Holding AG
HighBubendorf, Switzerland
GMPCOA
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
- Model
- CDMO
- Manufacturer?
- Yes
Biophore India Pharmaceuticals Pvt Ltd
HighHyderabad, India
GMP
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Fresenius Kabi iPSUM S.r.l.
HighVilladose (Rovigo), Italy
Fresenius Kabi's Italian API unit; its Villadose site near Venice develops and makes peptide APIs, also offered through Fresenius Kabi contract manufacturing. Holds US DMFs for 6 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Jiangsu Hansoh Pharmaceutical Group Co., Ltd
HighJiangsu, China
Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.
- Model
- Manufacturer
- Manufacturer?
- Yes
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
Sun Pharmaceutical Industries Ltd
LowMumbai, India
GMP
Mumbai-based generics group that makes APIs and finished medicines. Holds US Type II DMFs for 15 peptide APIs, including GLP-1s and GnRH analogues.
Notice: open regulatory issue
- 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)
- 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 Icatibant API?
Companies holding active US DMFs for Icatibant include Alembic Pharmaceuticals Ltd, Auro Peptides Ltd, BCN Peptides SA, MSN Life Sciences Private Ltd (MSN Group), TAPI NL B.V. (TAPI), AmbioPharm, Bachem Holding AG, Biophore India Pharmaceuticals Pvt Ltd, Fresenius Kabi iPSUM S.r.l., Jiangsu Hansoh Pharmaceutical Group Co., Ltd and 3 more. Other manufacturers may supply it without a US DMF.
Where are Icatibant API manufacturers based?
Among listed DMF holders: India (7), Spain (1), Netherlands (1), United States (1), Switzerland (1), Italy (1), China (1).
Do any Icatibant API holders have FDA warning letters?
Cipla Ltd, Sun Pharmaceutical Industries Ltd and USV Private Limited 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.