01 1Kyowa Hakko Bio Co., Ltd.
02 1Nissei Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia flavin adenine dinucleotide sodium (production only)
02 1Outsiders regulations adenine (production only)
01 2Japan
Japanese Pharmacopoeia Flavin Adenine Dinucleotide Sodium (For manufacturing only)
Registration Number : 228MF10210
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2016-11-09
Latest Date of Registration : 2016-11-09
Adenine (for manufacturing only)
Registration Number : 218MF10854
Registrant's Address : 4-1-45 Miyahara, Yodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-10-23
Latest Date of Registration : 2024-10-10
A Adenine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adenine, including repackagers and relabelers. The FDA regulates Adenine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adenine 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 Adenine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adenine supplier is an individual or a company that provides Adenine active pharmaceutical ingredient (API) or Adenine finished formulations upon request. The Adenine suppliers may include Adenine API manufacturers, exporters, distributors and traders.
click here to find a list of Adenine 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 Adenine Drug Master File in Japan (Adenine JDMF) empowers Adenine 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 Adenine JDMF during the approval evaluation for pharmaceutical products. At the time of Adenine 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 Adenine suppliers with JDMF on PharmaCompass.
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