Bivalirudin is a direct thrombin inhibitor used during PCI (Angiomax).
8 listed companies hold an active US Type II Drug Master File for Bivalirudin API, based in China (3), Netherlands (1), United States (1), Switzerland (1), Taiwan (1), India (1). 6 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.
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.
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.
US peptide API CDMO with facilities in the US and China.
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
API manufacturer and CDMO focused on complex generics, including peptides.
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.
Shenzhen-listed drug maker (002294) selling APIs and finished products; US DMF for bivalirudin.
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 Bivalirudin include Sinopep-Allsino Biopharmaceutical Co., Ltd., TAPI NL B.V. (TAPI), AmbioPharm, Bachem Holding AG, ScinoPharm Taiwan, ALP Pharm Beijing Co., Ltd., Shenzhen Salubris Pharmaceuticals Co., Ltd and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (3), Netherlands (1), United States (1), Switzerland (1), Taiwan (1), India (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.