01 1Aurisco Pharmaceutical
01 19-(2-PHOSPHONYLMETHOXYPROPYL) ADENINE
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22581
Submission : 2009-02-10
Status : Inactive
Type : II
88
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A Adefovir & Pmpa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adefovir & Pmpa, including repackagers and relabelers. The FDA regulates Adefovir & Pmpa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adefovir & Pmpa 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 & Pmpa supplier is an individual or a company that provides Adefovir & Pmpa active pharmaceutical ingredient (API) or Adefovir & Pmpa finished formulations upon request. The Adefovir & Pmpa suppliers may include Adefovir & Pmpa API manufacturers, exporters, distributors and traders.
click here to find a list of Adefovir & Pmpa suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Adefovir & Pmpa DMF (Drug Master File) is a document detailing the whole manufacturing process of Adefovir & Pmpa active pharmaceutical ingredient (API) in detail. Different forms of Adefovir & Pmpa DMFs exist exist since differing nations have different regulations, such as Adefovir & Pmpa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adefovir & Pmpa DMF submitted to regulatory agencies in the US is known as a USDMF. Adefovir & Pmpa USDMF includes data on Adefovir & Pmpa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adefovir & Pmpa USDMF is kept confidential to protect the manufacturer’s intellectual property.
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