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01 1EMA
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4437
Submission : 1982-01-25
Status : Inactive
Type : II
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PharmaCompass offers a list of Adefovir Diphosphate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Adefovir Diphosphate manufacturer or Adefovir Diphosphate supplier for your needs.
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A EMA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of EMA, including repackagers and relabelers. The FDA regulates EMA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. EMA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A EMA supplier is an individual or a company that provides EMA active pharmaceutical ingredient (API) or EMA finished formulations upon request. The EMA suppliers may include EMA API manufacturers, exporters, distributors and traders.
click here to find a list of EMA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A EMA DMF (Drug Master File) is a document detailing the whole manufacturing process of EMA active pharmaceutical ingredient (API) in detail. Different forms of EMA DMFs exist exist since differing nations have different regulations, such as EMA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A EMA DMF submitted to regulatory agencies in the US is known as a USDMF. EMA USDMF includes data on EMA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The EMA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of EMA suppliers with USDMF on PharmaCompass.
