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
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A Monuril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monuril, including repackagers and relabelers. The FDA regulates Monuril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monuril API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Monuril supplier is an individual or a company that provides Monuril active pharmaceutical ingredient (API) or Monuril finished formulations upon request. The Monuril suppliers may include Monuril API manufacturers, exporters, distributors and traders.
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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 Monuril Drug Master File in Japan (Monuril JDMF) empowers Monuril 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 Monuril JDMF during the approval evaluation for pharmaceutical products. At the time of Monuril JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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