01 1BMS Chemie
02 1Excella GmbH & Co. K.G.
03 1Ipca Laboratories Limited
04 1Sanwa Chemical Co., Ltd.
01 1BENZBROMARONE JP
02 1Benzbromarone
03 1Japanese Pharmacopoeia Benzbromarone
04 1Japanese Pharmacopoeia benzbromarone (production only)
01 1Gabon
02 1India
03 1Japan
04 1Serbia
Japanese Pharmacopoeia Benzbromarone
Registration Number : 222MF10115
Registrant's Address : 10, Lalita Apartment, 36 Nandanvan Society, Alkapuri, Vadodara. Gujarat. India
Initial Date of Registration : 2010-03-25
Latest Date of Registration : 2010-03-25
Registration Number : 218MF10913
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (West), Mumbai 400 067, India
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2013-04-05
Japanese Pharmacopoeia Benzbromarone (for manufacturing only)
Registration Number : 218MF10555
Registrant's Address : 24-8 Tamura 9-chome, Hiratsuka City, Kanagawa Prefecture
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2010-04-01
Registration Number : 220MF10049
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2008-02-05
Latest Date of Registration : 2008-02-05
A Benzbromarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzbromarone, including repackagers and relabelers. The FDA regulates Benzbromarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzbromarone 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 Benzbromarone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzbromarone supplier is an individual or a company that provides Benzbromarone active pharmaceutical ingredient (API) or Benzbromarone finished formulations upon request. The Benzbromarone suppliers may include Benzbromarone API manufacturers, exporters, distributors and traders.
click here to find a list of Benzbromarone 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 Benzbromarone Drug Master File in Japan (Benzbromarone JDMF) empowers Benzbromarone 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 Benzbromarone JDMF during the approval evaluation for pharmaceutical products. At the time of Benzbromarone 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 Benzbromarone suppliers with JDMF on PharmaCompass.
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