01 1Hybio Pharmaceutical Co. , Ltd.
02 1Sekisui Medical Co., Ltd.
01 2Ganirelix Acetate
01 1China
02 1Japan
Registration Number : 230MF10067
Registrant's Address : Hybio Medicine Park, No. 37, Keji C. 2nd St. Shenzhen High-tech Industrial Park, Guan...
Initial Date of Registration : 2018-05-31
Latest Date of Registration : 2018-05-31
Registration Number : 230MF10105
Registrant's Address : 2-1-3 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2018-08-08
Latest Date of Registration : 2018-08-08
A Ganirelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganirelix, including repackagers and relabelers. The FDA regulates Ganirelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganirelix 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 Ganirelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganirelix supplier is an individual or a company that provides Ganirelix active pharmaceutical ingredient (API) or Ganirelix finished formulations upon request. The Ganirelix suppliers may include Ganirelix API manufacturers, exporters, distributors and traders.
click here to find a list of Ganirelix 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 Ganirelix Drug Master File in Japan (Ganirelix JDMF) empowers Ganirelix 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 Ganirelix JDMF during the approval evaluation for pharmaceutical products. At the time of Ganirelix 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 Ganirelix suppliers with JDMF on PharmaCompass.
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