01 1Olon S. p. A.
02 3Sumitomo Chemical Co., Ltd.
01 1Bezafibrate "KOA"
02 1Bezafibrate (OK)
03 2Japanese Pharmacopoeia bezafibrate
01 1Italy
02 3Japan
Registration Number : 218MF10019
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2021-08-16
Japanese Pharmacopoeia Bezafibrate
Registration Number : 219MF10226
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration : 2007-07-06
Registration Number : 223MF10164
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-11-28
Latest Date of Registration : 2011-11-28
Japanese Pharmacopoeia Bezafibrate
Registration Number : 222MF10051
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-02-12
Latest Date of Registration : 2010-02-12
A Bezafibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bezafibrate, including repackagers and relabelers. The FDA regulates Bezafibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bezafibrate 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 Bezafibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bezafibrate supplier is an individual or a company that provides Bezafibrate active pharmaceutical ingredient (API) or Bezafibrate finished formulations upon request. The Bezafibrate suppliers may include Bezafibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bezafibrate 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 Bezafibrate Drug Master File in Japan (Bezafibrate JDMF) empowers Bezafibrate 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 Bezafibrate JDMF during the approval evaluation for pharmaceutical products. At the time of Bezafibrate 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 Bezafibrate suppliers with JDMF on PharmaCompass.
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