Ganirelix is a GnRH antagonist used in fertility treatment.
8 listed companies hold an active US Type II Drug Master File for Ganirelix API, based in India (2), China (2), United States (1), Netherlands (1), Spain (1), South Korea (1). 8 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.
Aspen Pharmacare's API site in Oss, Netherlands, with roots in 1923; makes peptides with a liquid-phase process plus hormones and heparin. Holds US DMFs for 4 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.
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
Gwangju peptide API maker founded in 2000 as Anygen, KOSDAQ-listed since 2016, with MFDS-approved GMP peptide plants; holds US DMFs for ganirelix and vasopressin.
Chinese peptide drug manufacturer producing APIs and finished products.
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 Ganirelix include Apicore LLC (RK Pharma), Aspen Oss B.V. (Aspen API), Auro Peptides Ltd, BCN Peptides SA, HLB Pep Co., Ltd. (formerly Anygen Co., Ltd.), Hybio Pharmaceutical, Harbin Jixianglong Biotech Co., Ltd. and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: India (2), China (2), United States (1), Netherlands (1), Spain (1), South Korea (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.