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01 1NELFINAVIR
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12178
Submission : 1996-10-22
Status : Inactive
Type : II
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A Nelfinavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nelfinavir, including repackagers and relabelers. The FDA regulates Nelfinavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nelfinavir 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 Nelfinavir supplier is an individual or a company that provides Nelfinavir active pharmaceutical ingredient (API) or Nelfinavir finished formulations upon request. The Nelfinavir suppliers may include Nelfinavir API manufacturers, exporters, distributors and traders.
click here to find a list of Nelfinavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nelfinavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Nelfinavir active pharmaceutical ingredient (API) in detail. Different forms of Nelfinavir DMFs exist exist since differing nations have different regulations, such as Nelfinavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nelfinavir DMF submitted to regulatory agencies in the US is known as a USDMF. Nelfinavir USDMF includes data on Nelfinavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nelfinavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nelfinavir suppliers with USDMF on PharmaCompass.
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