01 1Kyowa Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia magnesium silicate (manufacturing only)
01 1Japan
Japanese Pharmacopoeia Magnesium Silicate (for manufacturing only)
Registration Number : 221MF10246
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-11-16
Latest Date of Registration : 2009-11-16
A CCRIS 3941 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CCRIS 3941, including repackagers and relabelers. The FDA regulates CCRIS 3941 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CCRIS 3941 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 CCRIS 3941 supplier is an individual or a company that provides CCRIS 3941 active pharmaceutical ingredient (API) or CCRIS 3941 finished formulations upon request. The CCRIS 3941 suppliers may include CCRIS 3941 API manufacturers, exporters, distributors and traders.
click here to find a list of CCRIS 3941 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 CCRIS 3941 Drug Master File in Japan (CCRIS 3941 JDMF) empowers CCRIS 3941 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 CCRIS 3941 JDMF during the approval evaluation for pharmaceutical products. At the time of CCRIS 3941 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 CCRIS 3941 suppliers with JDMF on PharmaCompass.
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