01 1Procos S. p. A.
01 1Clofedanol Hydrochloride
01 1Italy
Registration Number : 217MF11129
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-10-19
A Clofedanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clofedanol, including repackagers and relabelers. The FDA regulates Clofedanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clofedanol 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 Clofedanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clofedanol supplier is an individual or a company that provides Clofedanol active pharmaceutical ingredient (API) or Clofedanol finished formulations upon request. The Clofedanol suppliers may include Clofedanol API manufacturers, exporters, distributors and traders.
click here to find a list of Clofedanol 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 Clofedanol Drug Master File in Japan (Clofedanol JDMF) empowers Clofedanol 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 Clofedanol JDMF during the approval evaluation for pharmaceutical products. At the time of Clofedanol 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 Clofedanol suppliers with JDMF on PharmaCompass.
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