01 1Manac Corporation
01 1Japanese Pharmacopoeia Furopuropion (production only)
01 1Japan
Japanese Pharmacopoeia Flopropion (for manufacturing only)
Registration Number : 217MF10673
Registrant's Address : 92 Minookicho, Fukuyama City, Hiroshima Prefecture
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2007-12-19
A Flopropione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flopropione, including repackagers and relabelers. The FDA regulates Flopropione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flopropione API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Flopropione supplier is an individual or a company that provides Flopropione active pharmaceutical ingredient (API) or Flopropione finished formulations upon request. The Flopropione suppliers may include Flopropione API manufacturers, exporters, distributors and traders.
click here to find a list of Flopropione 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 Flopropione Drug Master File in Japan (Flopropione JDMF) empowers Flopropione 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 Flopropione JDMF during the approval evaluation for pharmaceutical products. At the time of Flopropione 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 Flopropione suppliers with JDMF on PharmaCompass.
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