Exenatide is a GLP-1 receptor agonist; the active ingredient of Byetta and Bydureon.
5 listed companies hold an active US Type II Drug Master File for Exenatide API, based in India (2), Netherlands (1), Switzerland (1), China (1). 4 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.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
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.
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.
Peptide-focused CDMO running GMP manufacturing sites on three continents.
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.
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 Exenatide include MSN Life Sciences Private Ltd (MSN Group), TAPI NL B.V. (TAPI), PolyPeptide Group, ALP Pharm Beijing Co., Ltd. and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: India (2), Netherlands (1), Switzerland (1), China (1).
Sun Pharmaceutical Industries Ltd has 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.