01 1Kaneka Corporation
02 1Mitsubishi Gas Chemical Co., Ltd.
03 1Nisshin Pharma Co., Ltd.
01 1Day stations ubidecarenone (production only)
02 1Japanese Pharmacopoeia ubidecarenone
03 1Ubidecarenone
01 2Japan
02 1U.S.A
JP Ubidecarenone (for manufacturing only)
Registration Number : 217MF10446
Registrant's Address : 2-4 Nakanoshima 3-chome, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2009-09-04
Japanese Pharmacopoeia Ubidecarenone
Registration Number : 218MF10222
Registrant's Address : 2-5-2 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2009-12-09
Registration Number : 217MF11113
Registrant's Address : 25 Kanda Nishikicho 1-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-06-16
A Ubidecarenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ubidecarenone, including repackagers and relabelers. The FDA regulates Ubidecarenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ubidecarenone 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 Ubidecarenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ubidecarenone supplier is an individual or a company that provides Ubidecarenone active pharmaceutical ingredient (API) or Ubidecarenone finished formulations upon request. The Ubidecarenone suppliers may include Ubidecarenone API manufacturers, exporters, distributors and traders.
click here to find a list of Ubidecarenone 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 Ubidecarenone Drug Master File in Japan (Ubidecarenone JDMF) empowers Ubidecarenone 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 Ubidecarenone JDMF during the approval evaluation for pharmaceutical products. At the time of Ubidecarenone 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 Ubidecarenone suppliers with JDMF on PharmaCompass.
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