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
Tirzepatide API manufacturers
Tirzepatide is a dual GIP and GLP-1 receptor agonist; the active ingredient of Eli Lilly's Mounjaro and Zepbound.
28 listed companies hold an active US Type II Drug Master File for Tirzepatide API, based in China (23), India (3), United States (1), Netherlands (1). 12 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.
Tirzepatide API DMF holders (28)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Apicore LLC (RK Pharma)
HighEast Windsor, NJ, USA
GMP
RK Pharma subsidiary offering API process R&D, custom synthesis and generic APIs, with US offices and plants in Gujarat and Andhra Pradesh. Holds US DMFs for 6 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Biocon Ltd
HighBengaluru, India
GMP
Bengaluru biopharma company that makes generic APIs and complex formulations, including GLP-1 peptides. Holds US DMFs for liraglutide, semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Changzhou Pharmaceutical Factory (CPF)
HighChangzhou, China
GMP
Changzhou API and tablet maker founded 1949 with a record of US FDA, EU GMP and PMDA inspections; US DMFs for semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Chinese Peptide Company (CPC Scientific)
HighHangzhou, China
GMP
Hangzhou peptide CRDMO founded in 2001, part of CPC Scientific/Medtide, with production in China and the USA. Holds US DMFs for cetrorelix, semaglutide and tirzepatide.
- 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
Sinopep-Allsino Biopharmaceutical Co., Ltd.
HighLianyungang, Jiangsu, China
GMP
Jiangsu peptide CDMO and generic API supplier with large automated SPPS capacity; states it has passed four US FDA inspections. Holds US DMFs for 9 peptide APIs.
- 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
Yangzhou Aurisco Pharmaceutical Co., Ltd. (Aurisco)
HighYangzhou, China
GMP
Chinese maker of generic small-molecule, peptide and oligonucleotide APIs, founded in 1998, with an FDA-inspected site in Yangzhou. Holds US DMFs for semaglutide and tirzepatide.
- Model
- Manufacturer
- 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
Shenzhen JYMed Technology Co., Ltd. (JYMed Peptide)
HighShenzhen, China
GMP
Shenzhen peptide CDMO and API maker founded in 2009, with 13 cGMP lines and 85,000 L of SPPS/LPPS reactor volume. Holds US DMFs for 6 peptide APIs.
- 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
El-Peptido (Shanghai) Biopharmaceutical Co., Ltd
MediumShanghai, China
Shanghai bulk peptide maker supplying wholesalers; holds US DMFs for bremelanotide, semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Fujian Genohope Biotech Ltd
MediumPutian, China
Putian, Fujian peptide API maker founded in 2019 by New Hope and Taiwan's Genovior, focused on GLP-1 APIs. Holds US DMFs for semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Guizhou Utide Biotechnology Co., Ltd.
MediumZunyi, China
Zunyi, Guizhou peptide manufacturer offering development and kg-scale production; holds active US DMFs for tirzepatide and other peptides.
- Model
- CDMO
- Manufacturer?
- Yes
Hangzhou Apextide Biomedical Technology Co., Ltd.
MediumHangzhou, China
Hangzhou peptide and oligonucleotide CRDMO supporting projects from preclinical to commercial supply; holds active US DMFs for tirzepatide and inclisiran.
- Model
- CDMO
- Manufacturer?
- Yes
Hangzhou Hotide Biotech Co., Ltd.
MediumHangzhou, China
Hangzhou peptide developer offering peptide APIs, intermediates, impurities and ADC/PDC linkers plus custom synthesis and process development; holds an active US DMF for tirzepatide.
- 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
Nanjing Cellnuo Biopharmaceutical Co., Ltd
MediumNanjing, China
Nanjing supplier of insulin and metabolic peptide APIs with technology transfer services; US DMFs for semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Ningxia LabsChem Co., Ltd.
MediumShizuishan, China
Ningxia API and peptide maker founded in 2016 in Pingluo, offering peptide API development and manufacturing; holds US DMFs for semaglutide and tirzepatide.
- Model
- CDMO
- Manufacturer?
- Yes
Shenzhen Alvantis Pharma Co., Ltd.
MediumShenzhen, China
Shenzhen peptide company founded in 2020 making GLP-1 peptide APIs, sterile vials and peptide reference materials at a Zhongshan plant; holds an active US DMF for tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Sichuan Jisheng Biopharmaceutical Co., Ltd
MediumLeshan, China
Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Suzhou Motif Biotech Co., Ltd
MediumSuzhou, China
Suzhou peptide CRDMO with GMP workshops built to ICH Q7; US DMFs for semaglutide and tirzepatide.
- Model
- CDMO
- Manufacturer?
- Yes
Suzhou Ryway Biotech Co., Ltd.
MediumSuzhou, China
Suzhou API and intermediates producer offering customized manufacturing. Holds US DMFs for semaglutide, thymalfasin and tirzepatide.
- Model
- CDMO
- Manufacturer?
- Yes
Xiushi Biopharma (Nantong) Co., Ltd.
MediumNantong, China
Nantong company founded in 2020 that makes peptides by biosynthesis and offers peptide CMC development. Holds US DMFs for semaglutide and tirzepatide.
- Model
- CDMO
- 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
Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
LowNanjing, China
Nanjing maker of peptide, protein and polysaccharide APIs and finished products, registered in 2017. Holds US DMFs for semaglutide and tirzepatide. FDA warning letter issued Nov 2026.
Notice: open regulatory issue
- Model
- Manufacturer
- Manufacturer?
- Yes
Other peptide APIs
- Semaglutide API manufacturers (45)
- 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 Tirzepatide API?
Companies holding active US DMFs for Tirzepatide include Alembic Pharmaceuticals Ltd, Apicore LLC (RK Pharma), Biocon Ltd, Changzhou Pharmaceutical Factory (CPF), Chinese Peptide Company (CPC Scientific), MSN Life Sciences Private Ltd (MSN Group), Sinopep-Allsino Biopharmaceutical Co., Ltd., TAPI NL B.V. (TAPI), Yangzhou Aurisco Pharmaceutical Co., Ltd. (Aurisco), Hybio Pharmaceutical and 18 more. Other manufacturers may supply it without a US DMF.
Where are Tirzepatide API manufacturers based?
Among listed DMF holders: China (23), India (3), United States (1), Netherlands (1).
Do any Tirzepatide API holders have FDA warning letters?
Harbin Jixianglong Biotech Co., Ltd. and Nanjing Hanxin Pharmaceutical Technology 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.