01 1Kohjin Life Sciences Co., Ltd.
02 1Kyowa Hakko Bio Co., Ltd.
03 2Shandong Jincheng Bio-pharmaceutical Co. , Ltd.
01 1Glutathione
02 1Glutathione (drug substance intermediate)
03 1Japanese Pharmacopoeia glutathione
04 1Oxy glutathione Kyowa
01 2China
02 2Japan
Japanese Pharmacopoeia Glutathione
Registration Number : 217MF10303
Registrant's Address : 1-1-3 Yurakucho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-30
Latest Date of Registration : 2010-03-02
Registration Number : 217MF10240
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2014-12-08
Glutathione (pharmaceutical intermediate)
Registration Number : 304MF10007
Registrant's Address : Zichuan Economic Development Zone, Zibo City, Shandong Province, China
Initial Date of Registration : 2022-01-11
Latest Date of Registration : 2022-01-11
Registration Number : 223MF10160
Registrant's Address : Zichuan Economic Development Zone, Zibo City, Shandong Province, China
Initial Date of Registration : 2011-11-14
Latest Date of Registration : 2011-11-14
A Glutathione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutathione, including repackagers and relabelers. The FDA regulates Glutathione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutathione 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 Glutathione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glutathione supplier is an individual or a company that provides Glutathione active pharmaceutical ingredient (API) or Glutathione finished formulations upon request. The Glutathione suppliers may include Glutathione API manufacturers, exporters, distributors and traders.
click here to find a list of Glutathione 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 Glutathione Drug Master File in Japan (Glutathione JDMF) empowers Glutathione 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 Glutathione JDMF during the approval evaluation for pharmaceutical products. At the time of Glutathione 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 Glutathione suppliers with JDMF on PharmaCompass.
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