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01 1EMA
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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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A Adefovir Diphosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adefovir Diphosphate, including repackagers and relabelers. The FDA regulates Adefovir Diphosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adefovir Diphosphate 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 Adefovir Diphosphate supplier is an individual or a company that provides Adefovir Diphosphate active pharmaceutical ingredient (API) or Adefovir Diphosphate finished formulations upon request. The Adefovir Diphosphate suppliers may include Adefovir Diphosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Adefovir Diphosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adefovir Diphosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Adefovir Diphosphate active pharmaceutical ingredient (API) in detail. Different forms of Adefovir Diphosphate DMFs exist exist since differing nations have different regulations, such as Adefovir Diphosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adefovir Diphosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Adefovir Diphosphate USDMF includes data on Adefovir Diphosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adefovir Diphosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Adefovir Diphosphate suppliers with USDMF on PharmaCompass.
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