Cetrorelix is a GnRH antagonist used in fertility treatment (Cetrotide).
11 listed companies hold an active US Type II Drug Master File for Cetrorelix API, based in China (5), India (4), United States (1), Spain (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.
RK Pharma subsidiary offering API process R&D, custom synthesis and generic APIs, with US offices and plants in Gujarat and Andhra Pradesh. Holds US DMFs for 6 peptide APIs.
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
Hangzhou peptide CRDMO founded in 2001, part of CPC Scientific/Medtide, with production in China and the USA. Holds US DMFs for cetrorelix, semaglutide and tirzepatide.
Indian CDMO whose Turbhe, Navi Mumbai site develops and makes peptide APIs by solid- and solution-phase synthesis. Holds US DMFs for 9 peptide APIs.
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.
Chinese peptide drug manufacturer producing APIs and finished products.
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.
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.
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 Cetrorelix include Apicore LLC (RK Pharma), BCN Peptides SA, Chinese Peptide Company (CPC Scientific), Piramal Pharma Ltd (Piramal Pharma Solutions), Sinopep-Allsino Biopharmaceutical Co., Ltd., Hybio Pharmaceutical, ALP Pharm Beijing Co., Ltd., Biophore India Pharmaceuticals Pvt Ltd, Hemmo Pharmaceuticals Pvt Ltd (Piramal Pharma Solutions), Harbin Jixianglong Biotech Co., Ltd. and 1 more. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (5), India (4), United States (1), Spain (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.