01 1Katsura Chemical Co., Ltd.
01 1Gabexate mesylate
01 1Japan
Registration Number : 219MF10238
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2007-07-17
Latest Date of Registration : 2007-07-17
A Gabexato manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabexato, including repackagers and relabelers. The FDA regulates Gabexato manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabexato 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 Gabexato supplier is an individual or a company that provides Gabexato active pharmaceutical ingredient (API) or Gabexato finished formulations upon request. The Gabexato suppliers may include Gabexato API manufacturers, exporters, distributors and traders.
click here to find a list of Gabexato 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 Gabexato Drug Master File in Japan (Gabexato JDMF) empowers Gabexato 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 Gabexato JDMF during the approval evaluation for pharmaceutical products. At the time of Gabexato 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 Gabexato suppliers with JDMF on PharmaCompass.
We have 1 companies offering Gabexato
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
