01 1BCN Peptides S. A.
02 1Polypeptide Laboratories, Inc.
01 1Gonadorelin Diacetate
02 1Gonadorelin acetate
01 1Spain
02 1Switzerland
Registration Number : 305MF10023
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, B...
Initial Date of Registration : 2023-02-08
Latest Date of Registration : 2023-02-08
Registration Number : 219MF10020
Registrant's Address : 365 Maple Avenue, Torrance, CA 90503, USA
Initial Date of Registration : 2007-01-22
Latest Date of Registration : 2007-01-22
A Gonadorelin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gonadorelin Acetate, including repackagers and relabelers. The FDA regulates Gonadorelin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gonadorelin Acetate 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 Gonadorelin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gonadorelin Acetate supplier is an individual or a company that provides Gonadorelin Acetate active pharmaceutical ingredient (API) or Gonadorelin Acetate finished formulations upon request. The Gonadorelin Acetate suppliers may include Gonadorelin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Gonadorelin Acetate 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 Gonadorelin Acetate Drug Master File in Japan (Gonadorelin Acetate JDMF) empowers Gonadorelin Acetate 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 Gonadorelin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Gonadorelin Acetate 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 Gonadorelin Acetate suppliers with JDMF on PharmaCompass.
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