01 1ERCROS INDUSTRIAL,S. A.
01 1[Japanese Pharmacopoeia] fosfomycin calcium
01 1Spain
[Japanese Pharmacopoeia] Fosfomycin Calcium
Registration Number : 218MF10649
Registrant's Address : Paseo del Deleite, s/n 28300-Aranjuez, Madrid Spain
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2007-08-01
A Fosfomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin, including repackagers and relabelers. The FDA regulates Fosfomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin 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 Fosfomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin supplier is an individual or a company that provides Fosfomycin active pharmaceutical ingredient (API) or Fosfomycin finished formulations upon request. The Fosfomycin suppliers may include Fosfomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin 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 Fosfomycin Drug Master File in Japan (Fosfomycin JDMF) empowers Fosfomycin 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 Fosfomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin 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 Fosfomycin suppliers with JDMF on PharmaCompass.
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