01 1Bihoku Powder Industry Co., Ltd.
01 1Japanese Pharmacopoeia precipitated calcium carbonate (production only)
01 1Japan
"Japanese Pharmacopoeia Precipitated Calcium Carbonate" (for manufacturing 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
A Calcium Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Carbonate, including repackagers and relabelers. The FDA regulates Calcium Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Calcium Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Carbonate supplier is an individual or a company that provides Calcium Carbonate active pharmaceutical ingredient (API) or Calcium Carbonate finished formulations upon request. The Calcium Carbonate suppliers may include Calcium Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Carbonate 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 Calcium Carbonate Drug Master File in Japan (Calcium Carbonate JDMF) empowers Calcium Carbonate 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 Calcium Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Carbonate 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 Calcium Carbonate suppliers with JDMF on PharmaCompass.
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