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
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PharmaCompass offers a list of Calcium Carbonate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Calcium Carbonate manufacturer or Calcium Carbonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Carbonate manufacturer or Calcium Carbonate supplier.
PharmaCompass also assists you with knowing the Calcium Carbonate API Price utilized in the formulation of products. Calcium Carbonate API Price is not always fixed or binding as the Calcium Carbonate Price is obtained through a variety of data sources. The Calcium Carbonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Neolite SP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neolite SP, including repackagers and relabelers. The FDA regulates Neolite SP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neolite SP 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 Neolite SP supplier is an individual or a company that provides Neolite SP active pharmaceutical ingredient (API) or Neolite SP finished formulations upon request. The Neolite SP suppliers may include Neolite SP API manufacturers, exporters, distributors and traders.
click here to find a list of Neolite SP 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 Neolite SP Drug Master File in Japan (Neolite SP JDMF) empowers Neolite SP 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 Neolite SP JDMF during the approval evaluation for pharmaceutical products. At the time of Neolite SP 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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