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
Linaclotide API manufacturers
Linaclotide is a guanylate cyclase-C agonist for IBS with constipation (Linzess).
9 listed companies hold an active US Type II Drug Master File for Linaclotide API, based in India (3), China (3), Netherlands (1), Switzerland (1), Germany (1). 7 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.
Linaclotide API DMF holders (9)
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
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
Hybio Pharmaceutical
HighShenzhen, China
GMP
Chinese peptide drug manufacturer producing APIs and finished products.
- Model
- Manufacturer
- Manufacturer?
- Yes
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
CordenPharma
HighGermany / Switzerland / USA
GMPCOA
European CDMO network with a dedicated peptide, lipid and carbohydrate platform.
- Model
- CDMO
- Manufacturer?
- Yes
High
Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Hangzhou Thinheal Pharma-Tech Co., Ltd.
MediumHangzhou, China
Hangzhou peptide API maker and CDMO founded in 2019, supplying therapeutic and cosmetic peptides. Holds US DMFs for linaclotide, semaglutide and tirzepatide.
- Model
- CDMO
- 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
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)
- 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 Linaclotide API?
Companies holding active US DMFs for Linaclotide include Auro Peptides Ltd, MSN Life Sciences Private Ltd (MSN Group), TAPI NL B.V. (TAPI), Hybio Pharmaceutical, PolyPeptide Group, CordenPharma, Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd., Hangzhou Thinheal Pharma-Tech Co., Ltd. and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Where are Linaclotide API manufacturers based?
Among listed DMF holders: India (3), China (3), Netherlands (1), Switzerland (1), Germany (1).
Do any Linaclotide API holders have FDA warning letters?
Sun Pharmaceutical Industries Ltd 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.