01 1Corden PharmaChem nv
01 1Bufexamac
01 1Germany
Registration Number : 218MF10882
Registrant's Address : Industrypark Roosveld 2, B6, 3400 Landen, Belgium
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
A Bufexamac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bufexamac, including repackagers and relabelers. The FDA regulates Bufexamac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bufexamac 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 Bufexamac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bufexamac supplier is an individual or a company that provides Bufexamac active pharmaceutical ingredient (API) or Bufexamac finished formulations upon request. The Bufexamac suppliers may include Bufexamac API manufacturers, exporters, distributors and traders.
click here to find a list of Bufexamac 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 Bufexamac Drug Master File in Japan (Bufexamac JDMF) empowers Bufexamac 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 Bufexamac JDMF during the approval evaluation for pharmaceutical products. At the time of Bufexamac 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 Bufexamac suppliers with JDMF on PharmaCompass.
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