01 1Esteve Quimica, S. A.
01 1Riluzole
01 1Spain
Registration Number : 224MF10021
Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain
Initial Date of Registration : 2012-02-01
Latest Date of Registration : 2012-02-01
A Riluzole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riluzole, including repackagers and relabelers. The FDA regulates Riluzole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riluzole 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 Riluzole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riluzole supplier is an individual or a company that provides Riluzole active pharmaceutical ingredient (API) or Riluzole finished formulations upon request. The Riluzole suppliers may include Riluzole API manufacturers, exporters, distributors and traders.
click here to find a list of Riluzole 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 Riluzole Drug Master File in Japan (Riluzole JDMF) empowers Riluzole 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 Riluzole JDMF during the approval evaluation for pharmaceutical products. At the time of Riluzole 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 Riluzole suppliers with JDMF on PharmaCompass.
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