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
Plecanatide API manufacturers
Plecanatide is a guanylate cyclase-C agonist for chronic idiopathic constipation (Trulance).
5 listed companies hold an active US Type II Drug Master File for Plecanatide API, based in India (2), China (2), Taiwan (1). 4 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.
Plecanatide API DMF holders (5)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Chunghwa Chemical Synthesis & Biotech Co., Ltd. (Cenra API Solutions)
HighNew Taipei City, Taiwan
GMP
Taiwanese API maker founded in 1964, trading as Cenra API Solutions, offering CMO/CDMO services. Holds US DMFs for difelikefalin, plecanatide and setmelanotide.
- 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
Hybio Pharmaceutical
HighShenzhen, China
GMP
Chinese peptide drug manufacturer producing APIs and finished products.
- Model
- Manufacturer
- Manufacturer?
- Yes
ALP Pharm Beijing Co., Ltd.
HighBeijing, China
Beijing API company, founded 2006, that holds DMFs and has its APIs made in partner facilities under its own quality control. Holds US DMFs for 13 peptide APIs.
- 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)
- Etelcalcetide API manufacturers (4)
- Sincalide API manufacturers (4)
- Glucagon API manufacturers (3)
Related
Frequently asked questions
Who manufactures Plecanatide API?
Companies holding active US DMFs for Plecanatide include Auro Peptides Ltd, Chunghwa Chemical Synthesis & Biotech Co., Ltd. (Cenra API Solutions), MSN Life Sciences Private Ltd (MSN Group), Hybio Pharmaceutical and ALP Pharm Beijing Co., Ltd.. Other manufacturers may supply it without a US DMF.
Where are Plecanatide API manufacturers based?
Among listed DMF holders: India (2), China (2), Taiwan (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.