01 1Merck KGaA
02 1ZaCh System
01 1Saffinamide mesylate
02 1Safinamide Mesylate
01 1Gabon
02 1Germany
Registration Number : 230MF10101
Registrant's Address : Frankfurter Strasse 250 64293 Darmstadt Germany
Initial Date of Registration : 2018-08-02
Latest Date of Registration : 2018-08-02
Registration Number : 304MF10141
Registrant's Address : Z. I. La Croix Cadeau, 49240 Avrille, France
Initial Date of Registration : 2022-10-12
Latest Date of Registration : 2023-10-04
A Safinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide, including repackagers and relabelers. The FDA regulates Safinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide 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 Safinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Safinamide supplier is an individual or a company that provides Safinamide active pharmaceutical ingredient (API) or Safinamide finished formulations upon request. The Safinamide suppliers may include Safinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Safinamide 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 Safinamide Drug Master File in Japan (Safinamide JDMF) empowers Safinamide 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 Safinamide JDMF during the approval evaluation for pharmaceutical products. At the time of Safinamide 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 Safinamide suppliers with JDMF on PharmaCompass.
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