Teriparatide API manufacturers

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.

Teriparatide API DMF holders (11)

Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.

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
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
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

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
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
Hybio Pharmaceutical
Shenzhen, China
High
GMP

Chinese peptide drug manufacturer producing APIs and finished products.

Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedIn-House Production
ScinoPharm Taiwan
Tainan, Taiwan
High
GMP

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

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House Production

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

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
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
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

Other peptide APIs

Related

Frequently asked questions

Who manufactures Teriparatide API?

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.

Where are Teriparatide API manufacturers based?

Among listed DMF holders: India (4), China (4), Germany (1), United States (1), Taiwan (1).

Do any Teriparatide API holders have FDA warning letters?

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.

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.