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 Urbanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urbanol, including repackagers and relabelers. The FDA regulates Urbanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urbanol 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 Urbanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urbanol supplier is an individual or a company that provides Urbanol active pharmaceutical ingredient (API) or Urbanol finished formulations upon request. The Urbanol suppliers may include Urbanol API manufacturers, exporters, distributors and traders.
click here to find a list of Urbanol 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 Urbanol Drug Master File in Japan (Urbanol JDMF) empowers Urbanol 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 Urbanol JDMF during the approval evaluation for pharmaceutical products. At the time of Urbanol 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 Urbanol suppliers with JDMF on PharmaCompass.
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