01 1AMSA S. p. A.
01 1Flecainide acetate
01 1Italy
Registration Number : 223MF10093
Registrant's Address : VIALE DEL GHISALLO, 20 20151 MILAN ITALY
Initial Date of Registration : 2011-06-29
Latest Date of Registration : 2019-03-29
A Flecainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flecainide, including repackagers and relabelers. The FDA regulates Flecainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flecainide 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 Flecainide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flecainide supplier is an individual or a company that provides Flecainide active pharmaceutical ingredient (API) or Flecainide finished formulations upon request. The Flecainide suppliers may include Flecainide API manufacturers, exporters, distributors and traders.
click here to find a list of Flecainide 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 Flecainide Drug Master File in Japan (Flecainide JDMF) empowers Flecainide 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 Flecainide JDMF during the approval evaluation for pharmaceutical products. At the time of Flecainide 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 Flecainide suppliers with JDMF on PharmaCompass.
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