Sincalide is a cholecystokinin fragment used in gallbladder diagnostics (Kinevac).
4 listed companies hold an active US Type II Drug Master File for Sincalide API, based in India (3), Switzerland (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.
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
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 Sincalide include MSN Life Sciences Private Ltd (MSN Group), Bachem Holding AG, Biophore India Pharmaceuticals Pvt Ltd and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: India (3), Switzerland (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.