01 1Sun Chemical Co., Ltd.
01 1Procainamide hydrochloride
01 1China
Registration Number : 218MF10970
Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2006-12-01
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A MCULE-9726613752 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MCULE-9726613752, including repackagers and relabelers. The FDA regulates MCULE-9726613752 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MCULE-9726613752 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A MCULE-9726613752 supplier is an individual or a company that provides MCULE-9726613752 active pharmaceutical ingredient (API) or MCULE-9726613752 finished formulations upon request. The MCULE-9726613752 suppliers may include MCULE-9726613752 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 MCULE-9726613752 Drug Master File in Japan (MCULE-9726613752 JDMF) empowers MCULE-9726613752 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 MCULE-9726613752 JDMF during the approval evaluation for pharmaceutical products. At the time of MCULE-9726613752 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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