01 1Pfizer Inc
01 1VIDARABINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13730
Submission : 1998-09-01
Status : Inactive
Type : II
A Vidarabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vidarabine, including repackagers and relabelers. The FDA regulates Vidarabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vidarabine 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 Vidarabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vidarabine supplier is an individual or a company that provides Vidarabine active pharmaceutical ingredient (API) or Vidarabine finished formulations upon request. The Vidarabine suppliers may include Vidarabine API manufacturers, exporters, distributors and traders.
click here to find a list of Vidarabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vidarabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Vidarabine active pharmaceutical ingredient (API) in detail. Different forms of Vidarabine DMFs exist exist since differing nations have different regulations, such as Vidarabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vidarabine DMF submitted to regulatory agencies in the US is known as a USDMF. Vidarabine USDMF includes data on Vidarabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vidarabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vidarabine suppliers with USDMF on PharmaCompass.
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