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