Degarelix is a GnRH antagonist used in prostate cancer (Firmagon).
7 listed companies hold an active US Type II Drug Master File for Degarelix API, based in China (4), United States (1), India (1), Italy (1). 4 have a regulator record of GMP manufacturing.
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.
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.
Chinese peptide drug manufacturer producing APIs and finished products.
Fresenius Kabi's Italian API unit; its Villadose site near Venice develops and makes peptide APIs, also offered through Fresenius Kabi contract manufacturing. Holds US DMFs for 6 peptide APIs.
Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.
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.
Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.
Companies holding active US DMFs for Degarelix include Apicore LLC (RK Pharma), Auro Peptides Ltd, Hybio Pharmaceutical, Fresenius Kabi iPSUM S.r.l., Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Shenzhen JYMed Technology Co., Ltd. (JYMed Peptide) and Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd.. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (4), United States (1), India (1), Italy (1).
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.