01 1Ercros
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01 2FOSFOMYCIN SODIUM
01 1Spain
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01 2Active
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14341
Submission : 1999-08-04
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40622
Submission : 2024-09-29
Status : Active
Type : II
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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.
A Fosfomycin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin Sodium DMFs exist exist since differing nations have different regulations, such as Fosfomycin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosfomycin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin Sodium USDMF includes data on Fosfomycin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosfomycin Sodium suppliers with USDMF on PharmaCompass.
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