EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Germany GmbH
01 1Clobazam
01 1France
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 218MF10337
Registrant's Address : Brueningstrasse 50, 65926 Frankfurt am Main, Germany
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2010-01-07
A Onfi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onfi, including repackagers and relabelers. The FDA regulates Onfi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onfi 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 Onfi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Onfi supplier is an individual or a company that provides Onfi active pharmaceutical ingredient (API) or Onfi finished formulations upon request. The Onfi suppliers may include Onfi API manufacturers, exporters, distributors and traders.
click here to find a list of Onfi 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 Onfi Drug Master File in Japan (Onfi JDMF) empowers Onfi 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 Onfi JDMF during the approval evaluation for pharmaceutical products. At the time of Onfi 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 Onfi suppliers with JDMF on PharmaCompass.
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