01 1BCN Peptides S. A.
02 1Corden Pharma Brussels S. A.
01 1Cetrorelix Acetate
02 1Cetrorelix acetate
01 1Germany
02 1Spain
Registration Number : 306MF10147
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, B...
Initial Date of Registration : 2024-11-20
Latest Date of Registration : 2024-11-20
Registration Number : 224MF10121
Registrant's Address : 310, Rue de Ransbeek, B-1120 Brussels, Belgium
Initial Date of Registration : 2012-07-04
Latest Date of Registration : 2021-01-14
A Cetrorelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetrorelix, including repackagers and relabelers. The FDA regulates Cetrorelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetrorelix API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cetrorelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetrorelix supplier is an individual or a company that provides Cetrorelix active pharmaceutical ingredient (API) or Cetrorelix finished formulations upon request. The Cetrorelix suppliers may include Cetrorelix API manufacturers, exporters, distributors and traders.
click here to find a list of Cetrorelix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Cetrorelix Drug Master File in Japan (Cetrorelix JDMF) empowers Cetrorelix API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Cetrorelix JDMF during the approval evaluation for pharmaceutical products. At the time of Cetrorelix JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Cetrorelix suppliers with JDMF on PharmaCompass.
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