01 3Alps Pharmaceutical Co., Ltd.
01 1Glycyrrhetinic Acid
02 2Glycyrrhetinic acid
01 3Japan
Registration Number : 217MF11025
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2008-07-24
Registration Number : 228MF10079
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2016-04-06
Latest Date of Registration : 2016-04-06
Registration Number : 304MF10076
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2022-05-18
Latest Date of Registration : 2022-05-18
A Enoxolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enoxolone, including repackagers and relabelers. The FDA regulates Enoxolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enoxolone 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 Enoxolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enoxolone supplier is an individual or a company that provides Enoxolone active pharmaceutical ingredient (API) or Enoxolone finished formulations upon request. The Enoxolone suppliers may include Enoxolone API manufacturers, exporters, distributors and traders.
click here to find a list of Enoxolone 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 Enoxolone Drug Master File in Japan (Enoxolone JDMF) empowers Enoxolone 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 Enoxolone JDMF during the approval evaluation for pharmaceutical products. At the time of Enoxolone 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 Enoxolone suppliers with JDMF on PharmaCompass.
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