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.
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Teriparatide is a recombinant or synthetic fragment of parathyroid hormone used for osteoporosis (Forteo).
11 listed companies hold an active US Type II Drug Master File for Teriparatide API, based in India (4), China (4), Germany (1), United States (1), Taiwan (1). 10 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.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
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.
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.
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.
Hamburg microbial biologics CDMO founded 1987, now wholly owned by Gedeon Richter; FDA-inspected 2013, 2018 and 2026; US DMF for teriparatide.
US peptide API CDMO with facilities in the US and China.
Chinese peptide drug manufacturer producing APIs and finished products.
API manufacturer and CDMO focused on complex generics, including peptides.
Nanjing API subsidiary of Nasdaq-listed Amphastar; US DMF for teriparatide.
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.
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.
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.
Companies holding active US DMFs for Teriparatide include Alembic Pharmaceuticals Ltd, Auro Peptides Ltd, MSN Life Sciences Private Ltd (MSN Group), Richter-Helm BioTec GmbH & Co. KG (Richter BioLogics), AmbioPharm, Hybio Pharmaceutical, ScinoPharm Taiwan, Amphastar Nanjing Pharmaceuticals Inc (ANP), Shenzhen JYMed Technology Co., Ltd. (JYMed Peptide), Harbin Jixianglong Biotech Co., Ltd. and 1 more. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: India (4), China (4), Germany (1), United States (1), Taiwan (1).
Harbin Jixianglong Biotech Co., Ltd. and Sun Pharmaceutical Industries Ltd have an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.