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, Price,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.
PharmaCompass also assists you with knowing the Citicoline Sodium API Price utilized in the formulation of products. Citicoline Sodium API Price is not always fixed or binding as the Citicoline Sodium Price is obtained through a variety of data sources. The Citicoline Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Citicoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citicoline, including repackagers and relabelers. The FDA regulates Citicoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citicoline 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 Citicoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citicoline supplier is an individual or a company that provides Citicoline active pharmaceutical ingredient (API) or Citicoline finished formulations upon request. The Citicoline suppliers may include Citicoline API manufacturers, exporters, distributors and traders.
click here to find a list of Citicoline 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 Citicoline Drug Master File in Japan (Citicoline JDMF) empowers Citicoline 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 Citicoline JDMF during the approval evaluation for pharmaceutical products. At the time of Citicoline 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 Citicoline suppliers with JDMF on PharmaCompass.
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