01 1Bihoku Powdering Industry Co., Ltd.
01 1Japanese Pharmacopoeia precipitated calcium carbonate (production only)
01 1Japan
"Japanese Pharmacopoeia Precipitated Calcium Carbonate" (For manufacturing purposes only)
Registration Number : 217MF10309
Registrant's Address : 704 Nishikata, Niimi City, Okayama Prefecture
Initial Date of Registration : 2005-07-11
Latest Date of Registration : 2006-11-15
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A R Jutan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of R Jutan, including repackagers and relabelers. The FDA regulates R Jutan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. R Jutan 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 R Jutan supplier is an individual or a company that provides R Jutan active pharmaceutical ingredient (API) or R Jutan finished formulations upon request. The R Jutan suppliers may include R Jutan API manufacturers, exporters, distributors and traders.
click here to find a list of R Jutan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 R Jutan Drug Master File in Japan (R Jutan JDMF) empowers R Jutan 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 R Jutan JDMF during the approval evaluation for pharmaceutical products. At the time of R Jutan 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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