01 1Hovione LLC
01 1Abakopan drug substance
01 1Portugal
Registration Number : 303MF10022
Registrant's Address : 40 Lake Drive, East Windsor, NJ08520, USA
Initial Date of Registration : 2021-01-28
Latest Date of Registration : 2021-09-09
A Avacopan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avacopan, including repackagers and relabelers. The FDA regulates Avacopan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avacopan 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 Avacopan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avacopan supplier is an individual or a company that provides Avacopan active pharmaceutical ingredient (API) or Avacopan finished formulations upon request. The Avacopan suppliers may include Avacopan API manufacturers, exporters, distributors and traders.
click here to find a list of Avacopan 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 Avacopan Drug Master File in Japan (Avacopan JDMF) empowers Avacopan 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 Avacopan JDMF during the approval evaluation for pharmaceutical products. At the time of Avacopan 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 Avacopan suppliers with JDMF on PharmaCompass.
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