01 1ERCROS S. A.
02 1Northeast Pharmaceutical Group Co. , Ltd.
03 1Shin Poong Pharm. Co. , Ltd.
01 1Fosfomycin Sodium
02 1Fosfomycin sodium
03 1Japanese Pharmacopoeia Fosfomycin sodium (manufactured only)
01 1China
02 1South Korea
03 1Spain
Registration Number : 301MF10083
Registrant's Address : Paseo del Deleite, s/n 28300-Aranjuez, Madrid Spain
Initial Date of Registration : 2019-10-25
Latest Date of Registration : 2019-10-25
JP Fosfomycin Sodium (For manufacturing only)
Registration Number : 218MF10058
Registrant's Address : No. 8, Kunminghu Street, Economic & Technology Development District, Shenyang, China
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2016-03-18
Registration Number : 217MF10754
Registrant's Address : 161, Yeoksam-ro, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2024-03-06
A Fosfomycin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin Sodium, including repackagers and relabelers. The FDA regulates Fosfomycin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin Sodium supplier is an individual or a company that provides Fosfomycin Sodium active pharmaceutical ingredient (API) or Fosfomycin Sodium finished formulations upon request. The Fosfomycin Sodium suppliers may include Fosfomycin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin Sodium 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 Sodium Drug Master File in Japan (Fosfomycin Sodium JDMF) empowers Fosfomycin Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Sodium 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 Sodium suppliers with JDMF on PharmaCompass.
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