01 2Oryza Oil & Fat Chemical Co., Ltd.
02 1Sanyo Chemical Industries, Ltd.
03 1Tsuno Rice Fine Chemicals Co., Ltd.
01 1Benzalkonium chloride solution (GEM)
02 2γ - oryzanol
03 1γ-oryzanol
01 1Gabon
02 3Japan
Registration Number : 224MF10117
Registrant's Address : 1 Numata, Kitakata, Kitakata-cho, Ichinomiya City, Aichi Prefecture
Initial Date of Registration : 2012-07-04
Latest Date of Registration : 2012-07-04
Registration Number : 302MF10120
Registrant's Address : 1 Numata, Kitakata, Kitakata-cho, Ichinomiya City, Aichi Prefecture
Initial Date of Registration : 2020-10-05
Latest Date of Registration : 2020-10-05
Registration Number : 217MF10621
Registrant's Address : 2283 Chonomachi, Katsuragi-cho, Ito-gun, Wakayama Prefecture
Initial Date of Registration : 2005-09-20
Latest Date of Registration : 2009-10-26
Benzalkonium chloride solution (GEM)
Registration Number : 217MF11264
Registrant's Address : 11-1 Hitotsubashi-no-motocho, Higashiyama-ku, Kyoto City, Kyoto Prefecture
Initial Date of Registration : 2005-12-20
Latest Date of Registration : 2008-05-13
A Gamma Oryzanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gamma Oryzanol, including repackagers and relabelers. The FDA regulates Gamma Oryzanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gamma Oryzanol 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 Gamma Oryzanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gamma Oryzanol supplier is an individual or a company that provides Gamma Oryzanol active pharmaceutical ingredient (API) or Gamma Oryzanol finished formulations upon request. The Gamma Oryzanol suppliers may include Gamma Oryzanol API manufacturers, exporters, distributors and traders.
click here to find a list of Gamma Oryzanol 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 Gamma Oryzanol Drug Master File in Japan (Gamma Oryzanol JDMF) empowers Gamma Oryzanol 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 Gamma Oryzanol JDMF during the approval evaluation for pharmaceutical products. At the time of Gamma Oryzanol 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 Gamma Oryzanol suppliers with JDMF on PharmaCompass.
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