Peptide API manufacturers by molecule

77 listed companies hold active US Type II Drug Master Files (DMFs) for finished peptide APIs, covering 45 molecules. The data comes from FDA's public DMF list; intermediates, side chains and fragments are excluded.

A DMF lets a drug maker reference the API supplier's manufacturing information in its own FDA application. FDA does not approve DMFs, so a DMF is evidence of a regulatory filing, not of approval.

Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.

Companies holding peptide API DMFs (77)

High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
Apicore LLC (RK Pharma)
East Windsor, NJ, USA
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
High
GMP

Aspen Pharmacare's API site in Oss, Netherlands, with roots in 1923; makes peptides with a liquid-phase process plus hormones and heparin. Holds US DMFs for 4 peptide APIs.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
GMP

Tianjin unit of Asymchem, a CDMO listed in Shenzhen and Hong Kong that makes peptides and oligos; US DMFs for liraglutide and semaglutide.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedCDMO
Auro Peptides Ltd
Sangareddy (near Hyderabad), India
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
BCN Peptides SA
Sant Quinti de Mediona (Barcelona), Spain
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
Biocon Ltd
Bengaluru, India
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesale
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
FDC Limited
Mumbai, India
High
GMP

Mumbai drugmaker founded in 1936 with six plants, including a US-FDA-accredited API site at Roha; holds an active US DMF for semaglutide.

Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedUS-FDA Accredited SiteUS DMF HolderIn-House Production
Gland Pharma Ltd
Hyderabad, India
High
GMP

Hyderabad injectables CDMO founded 1978, promoted by Fosun Pharma; FDA-inspected sites; US DMF for glatiramer acetate.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleCDMO
GMPISO

Gwangju peptide API maker founded in 2000 as Anygen, KOSDAQ-listed since 2016, with MFDS-approved GMP peptide plants; holds US DMFs for ganirelix and vasopressin.

Notice: open regulatory issue
Model
CDMO
Manufacturer?
Yes
GMP CertifiedMFDS GMPCDMO ServicesUS DMF HolderCustom Peptides
JSC Grindeks
Riga, Latvia
High
GMP

Riga drug maker operating since 1946 that now offers CDMO services; WHO-inspected oxytocin API site; US DMF for oxytocin.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleCDMO
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
GMP

Indian CDMO whose Turbhe, Navi Mumbai site develops and makes peptide APIs by solid- and solution-phase synthesis. Holds US DMFs for 9 peptide APIs.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
GMP

Hamburg microbial biologics CDMO founded 1987, now wholly owned by Gedeon Richter; FDA-inspected 2013, 2018 and 2026; US DMF for teriparatide.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedCDMO
High
GMP

Raichur API and CDMO subsidiary of Shilpa Medicare; US DMFs for desmopressin, liraglutide and octreotide; Raichur units inspected by US FDA in 2025.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleCDMO
GMP

Neijiang, Sichuan injectables and API maker founded in 2010, listed on Shanghai's STAR Market, with FDA and UK MHRA GMP inspections; holds an active US DMF for lanreotide.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedFDA InspectedCDMO ServicesUS DMF HolderInjectables
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
TAPI NL B.V. (TAPI)
Amsterdam, Netherlands
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
AmbioPharm
North Augusta, South Carolina, USA
High
GMPCOA

US peptide API CDMO with facilities in the US and China.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
Bachem Holding AG
Bubendorf, Switzerland
High
GMPCOA

Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
CBL Patras
Patras, Greece
High
GMPCOA

Greek peptide manufacturer producing GMP and non-GMP peptides and resins.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionCOAs Available
Hybio Pharmaceutical
Shenzhen, China
High
GMP

Chinese peptide drug manufacturer producing APIs and finished products.

Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedIn-House Production
Neuland Laboratories
Hyderabad, India
High
GMPCOA

Indian API manufacturer and CDMO with a peptide synthesis platform.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
PolyPeptide Group
Baar, Switzerland (sites in SE, BE, FR, US, IN)
High
GMPCOA

Peptide-focused CDMO running GMP manufacturing sites on three continents.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
ScinoPharm Taiwan
Tainan, Taiwan
High
GMP

API manufacturer and CDMO focused on complex generics, including peptides.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House Production
High

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
WholesaleInternational Shipping
Amneal Pharmaceuticals LLC
Bridgewater, NJ, USA
High

US generics, specialty and biosimilars company with operations in the US, India and Ireland; US DMF for glatiramer acetate.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Nanjing API subsidiary of Nasdaq-listed Amphastar; US DMF for teriparatide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
C S Bio Co (CSBio)
Milpitas, CA, USA
High
ISO

California peptide synthesizer maker founded 1993 that also runs a cGMP peptide CDMO site in Milpitas; US DMF for triptorelin.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleCDMO
Chemi S.p.A.
Patrica, Italy
High

Italian API maker in the Italfarmaco Group, founded 1973, producing peptides since 1996; US DMFs for leuprolide and octreotide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Chongqing maker of diabetes and obesity drugs, active since 2015 and controlled by Zhifei (300122) since 2025; US DMFs for liraglutide and semaglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
GMP

Chongqing API maker founded in 2016 covering high-potency APIs, peptides and XDC compounds with CDMO services; reports FDA on-site inspections in 2024 and 2025 and holds a US DMF for semaglutide.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedFDA InspectedCDMO ServicesUS DMF HolderHPAPI
CordenPharma
Germany / Switzerland / USA
High
GMPCOA

European CDMO network with a dedicated peptide, lipid and carbohydrate platform.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
Fresenius Kabi iPSUM S.r.l.
Villadose (Rovigo), Italy
High

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
In-House ProductionWholesaleInternational Shipping

Hangzhou recombinant drug maker listed in Hong Kong (02566), formerly Huadong Medicine's gene engineering centre; US DMF for liraglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Hangzhou drug maker incorporated 1993, part of Shenzhen-listed Huadong Medicine; two group entities hold US DMFs for semaglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
GMP

Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleCDMO

Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping

Shenzhen-listed drug maker (002294) selling APIs and finished products; US DMF for bivalirudin.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Suzhou API and intermediate maker founded in 2000 offering CDMO/CMO services; holds an active US DMF for semaglutide.

Model
CDMO
Manufacturer?
Yes
In-House ProductionCDMO ServicesUS DMF HolderAPIs & Intermediates

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
In-House ProductionWholesaleInternational Shipping
Zydus Worldwide DMCC
Dubai, United Arab Emirates
High

Dubai-incorporated subsidiary of Zydus Lifesciences, the Ahmedabad drug group listed in India; US DMF for semaglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Beijing biotech founded in 2018 that develops and produces recombinant protein and peptide drugs in E. coli for metabolic disease; holds an active US DMF for semaglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionUS DMF HolderRecombinant Peptides
Medium

Swiss Debiopharm plant in Martigny making triptorelin sustained-release products; US DMF for triptorelin pamoate microgranules.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Shanghai bulk peptide maker supplying wholesalers; holds US DMFs for bremelanotide, semaglutide and tirzepatide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
Medium

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
In-House ProductionWholesaleInternational Shipping

Zunyi, Guizhou peptide manufacturer offering development and kg-scale production; holds active US DMFs for tirzepatide and other peptides.

Model
CDMO
Manufacturer?
Yes
In-House ProductionCDMO ServicesUS DMF HolderResearch Peptides

Hangzhou peptide and oligonucleotide CRDMO supporting projects from preclinical to commercial supply; holds active US DMFs for tirzepatide and inclisiran.

Model
CDMO
Manufacturer?
Yes
CDMO ServicesIn-House ProductionUS DMF HolderOligonucleotides
ISO

Hangzhou peptide maker founded in 2014 offering pharmaceutical, cosmetic and catalog peptides plus peptide CRO/CDMO work; holds an active US DMF for semaglutide.

Model
CDMO
Manufacturer?
Yes
In-House ProductionCDMO ServicesISO 9001US DMF HolderCustom Peptides
Medium

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
In-House ProductionCDMO ServicesUS DMF HolderPeptide Impurities

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
In-House ProductionWholesaleInternational Shipping
Hetero Drugs Ltd
Hyderabad, India
Medium

Privately held Hyderabad generics and API group with 36+ plants; US DMFs for semaglutide and vasopressin.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Changchun biopharmaceutical maker of somatropin, semaglutide and other APIs; holds active US DMFs for semaglutide and somatropin.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionUS DMF HolderRecombinant APIs

Nanjing supplier of insulin and metabolic peptide APIs with technology transfer services; US DMFs for semaglutide and tirzepatide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
Medium

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
In-House ProductionCDMO ServicesUS DMF HolderAPIs & Intermediates

Weihai Sino-US joint venture founded 2016 making peptide APIs and cosmetic peptides; US DMFs for leuprolide and semaglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesaleCustom Synthesis
Medium

Navi Mumbai biopharma and specialty pharma company; US DMFs for lanreotide and liraglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
Medium

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
In-House ProductionUS DMF HolderReference StandardsCustom Peptides
Medium

Shenzhen synthetic-biology ingredient maker with semaglutide as its lead biopharma product; US DMFs for semaglutide main chain and side chain.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesaleCustom Synthesis
Medium

Suzhou peptide CRDMO with GMP workshops built to ICH Q7; US DMFs for semaglutide and tirzepatide.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleCDMOCustom Synthesis
Medium

Suzhou API and intermediates producer offering customized manufacturing. Holds US DMFs for semaglutide, thymalfasin and tirzepatide.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleInternational Shipping

Wuhan fermentation-based CDMO founded 2008 making GLP-1 APIs, proteases and cell products; US DMFs for semaglutide and its main chain.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleCDMO

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
In-House ProductionWholesaleInternational Shipping
Medium

Hangzhou company founded in 2020 that makes GLP-1 peptides by fermentation plus semi-synthesis; holds an active US DMF for semaglutide API.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionUS DMF HolderGLP-1 Peptides
Cipla Ltd
Mumbai, India
Low
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
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
In-House ProductionWholesaleInternational Shipping

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
In-House ProductionWholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
USV Private Limited
Mumbai, India
Low
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
In-House ProductionWholesaleInternational Shipping
GMP

Large Zhejiang API and generic drug maker founded in 1989 and listed in Shanghai; holds active US DMFs for semaglutide and a semaglutide intermediate. It has an open FDA warning letter from June 2025.

Notice: open regulatory issue
Model
Manufacturer
Manufacturer?
Yes
FDA InspectedUS DMF HolderIn-House ProductionAPIs & Finished Dosage

Peptide APIs

Related

Frequently asked questions

Which peptide APIs have the most DMF holders?

Semaglutide (45), Tirzepatide (28), Liraglutide (20), Octreotide (20), Icatibant (13), Leuprolide (12).

Does a DMF mean the API is FDA approved?

No. FDA reviews a DMF only when a drug application references it, and it does not approve DMFs on their own. Check the holder's FDA inspection history and any warning letters as well.