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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PharmaCompass offers a list of Fosfomycin Trometamol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fosfomycin Trometamol manufacturer or Fosfomycin Trometamol supplier for your needs.
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PharmaCompass also assists you with knowing the Fosfomycin Trometamol API Price utilized in the formulation of products. Fosfomycin Trometamol API Price is not always fixed or binding as the Fosfomycin Trometamol Price is obtained through a variety of data sources. The Fosfomycin Trometamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fosfomycin Tromethamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin Tromethamine, including repackagers and relabelers. The FDA regulates Fosfomycin Tromethamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin Tromethamine 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 Fosfomycin Tromethamine supplier is an individual or a company that provides Fosfomycin Tromethamine active pharmaceutical ingredient (API) or Fosfomycin Tromethamine finished formulations upon request. The Fosfomycin Tromethamine suppliers may include Fosfomycin Tromethamine 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 Fosfomycin Tromethamine Drug Master File in Japan (Fosfomycin Tromethamine JDMF) empowers Fosfomycin Tromethamine 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 Tromethamine JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Tromethamine 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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