01 1Kyowa Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia calcium hydrogen phosphate hydrate (manufactured only)
01 1Japan
Japanese Pharmacopoeia Calcium Hydrogen Phosphate Hydrate (For manufacturing purposes only)
Registration Number : 221MF10072
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-04-08
Latest Date of Registration : 2009-04-08
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PharmaCompass offers a list of Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate manufacturer or Dibasic Calcium Phosphate Dihydrate supplier for your needs.
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PharmaCompass also assists you with knowing the Dibasic Calcium Phosphate Dihydrate API Price utilized in the formulation of products. Dibasic Calcium Phosphate Dihydrate API Price is not always fixed or binding as the Dibasic Calcium Phosphate Dihydrate Price is obtained through a variety of data sources. The Dibasic Calcium Phosphate Dihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dibasic Calcium Phosphate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dibasic Calcium Phosphate Dihydrate, including repackagers and relabelers. The FDA regulates Dibasic Calcium Phosphate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate supplier is an individual or a company that provides Dibasic Calcium Phosphate Dihydrate active pharmaceutical ingredient (API) or Dibasic Calcium Phosphate Dihydrate finished formulations upon request. The Dibasic Calcium Phosphate Dihydrate suppliers may include Dibasic Calcium Phosphate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate Drug Master File in Japan (Dibasic Calcium Phosphate Dihydrate JDMF) empowers Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate suppliers with JDMF on PharmaCompass.
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