01 1Sun Chemical Co., Ltd.
01 1Hibenzate tipepidine
01 1China
Registration Number : 217MF10347
Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2011-09-28
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PharmaCompass offers a list of 31139-87-4 API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right 31139-87-4 manufacturer or 31139-87-4 supplier for your needs.
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A 31139-87-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 31139-87-4, including repackagers and relabelers. The FDA regulates 31139-87-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 31139-87-4 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 31139-87-4 supplier is an individual or a company that provides 31139-87-4 active pharmaceutical ingredient (API) or 31139-87-4 finished formulations upon request. The 31139-87-4 suppliers may include 31139-87-4 API manufacturers, exporters, distributors and traders.
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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 31139-87-4 Drug Master File in Japan (31139-87-4 JDMF) empowers 31139-87-4 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 31139-87-4 JDMF during the approval evaluation for pharmaceutical products. At the time of 31139-87-4 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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