01 2Kyowa Hakko Bio Co., Ltd.
01 1Japanese Pharmacopoeia Citicoline (for manufacturing purposes only)
02 1Japanese Pharmacopoeia citicoline (production only)
01 2Japan
Japanese Pharmacopoeia Citicoline (for manufacturing purposes only)
Registration Number : 217MF10245
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2017-04-14
Japanese Pharmacopoeia Citicoline (for manufacturing purposes only)
Registration Number : 307MF10110
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2025-08-28
Latest Date of Registration : 2025-08-28
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PharmaCompass offers a list of Citicoline Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Citicoline Sodium manufacturer or Citicoline Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Citicoline Sodium manufacturer or Citicoline Sodium supplier.
A cdp-choline sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of cdp-choline sodium, including repackagers and relabelers. The FDA regulates cdp-choline sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. cdp-choline sodium 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 cdp-choline sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A cdp-choline sodium supplier is an individual or a company that provides cdp-choline sodium active pharmaceutical ingredient (API) or cdp-choline sodium finished formulations upon request. The cdp-choline sodium suppliers may include cdp-choline sodium API manufacturers, exporters, distributors and traders.
click here to find a list of cdp-choline sodium 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 cdp-choline sodium Drug Master File in Japan (cdp-choline sodium JDMF) empowers cdp-choline sodium 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 cdp-choline sodium JDMF during the approval evaluation for pharmaceutical products. At the time of cdp-choline sodium 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 cdp-choline sodium suppliers with JDMF on PharmaCompass.
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