01 1Active Pharma Inc.
01 1Japanese Pharmacopoeia gabexate (production only)
01 1Japan
Japanese Pharmacopoeia Gabexate Mesilate (For manufacturing only)
Registration Number : 217MF10198
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-08
Latest Date of Registration : 2013-06-07
A Gabexate Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabexate Mesylate, including repackagers and relabelers. The FDA regulates Gabexate Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabexate Mesylate 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 Gabexate Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gabexate Mesylate supplier is an individual or a company that provides Gabexate Mesylate active pharmaceutical ingredient (API) or Gabexate Mesylate finished formulations upon request. The Gabexate Mesylate suppliers may include Gabexate Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Gabexate Mesylate 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 Gabexate Mesylate Drug Master File in Japan (Gabexate Mesylate JDMF) empowers Gabexate Mesylate 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 Gabexate Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Gabexate Mesylate 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 Gabexate Mesylate suppliers with JDMF on PharmaCompass.
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