01 1Sogo Pharmaceutical Co., Ltd.
01 1Mepitiostane
01 1Japan
Registration Number : 217MF10430
Registrant's Address : 2-6-2 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2010-03-16
A Mepitiostane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mepitiostane, including repackagers and relabelers. The FDA regulates Mepitiostane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mepitiostane API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mepitiostane supplier is an individual or a company that provides Mepitiostane active pharmaceutical ingredient (API) or Mepitiostane finished formulations upon request. The Mepitiostane suppliers may include Mepitiostane API manufacturers, exporters, distributors and traders.
click here to find a list of Mepitiostane 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 Mepitiostane Drug Master File in Japan (Mepitiostane JDMF) empowers Mepitiostane 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 Mepitiostane JDMF during the approval evaluation for pharmaceutical products. At the time of Mepitiostane 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 Mepitiostane suppliers with JDMF on PharmaCompass.
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