01 1Kongo Chemical Co., Ltd.
01 1Hydrochloric acid eprazinone (production only)
01 1Japan
Eprazinone hydrochloride (for manufacturing only)
Registration Number : 217MF11193
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
A 10402-53-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 10402-53-6, including repackagers and relabelers. The FDA regulates 10402-53-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 10402-53-6 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 10402-53-6 supplier is an individual or a company that provides 10402-53-6 active pharmaceutical ingredient (API) or 10402-53-6 finished formulations upon request. The 10402-53-6 suppliers may include 10402-53-6 API manufacturers, exporters, distributors and traders.
click here to find a list of 10402-53-6 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 10402-53-6 Drug Master File in Japan (10402-53-6 JDMF) empowers 10402-53-6 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 10402-53-6 JDMF during the approval evaluation for pharmaceutical products. At the time of 10402-53-6 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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