01 1Aurobindo Pharma Limited
02 1UQUIFA
03 1Viatris
01 1AG 1346
02 2NELFINAVIR MESYLATE
01 1India
02 1Spain
03 1U.S.A
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18454
Submission : 2005-06-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12326
Submission : 1997-01-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18500
Submission : 2005-07-12
Status : Inactive
Type : II
A Nelfinavir Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nelfinavir Mesylate, including repackagers and relabelers. The FDA regulates Nelfinavir Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nelfinavir Mesylate 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 Mesylate supplier is an individual or a company that provides Nelfinavir Mesylate active pharmaceutical ingredient (API) or Nelfinavir Mesylate finished formulations upon request. The Nelfinavir Mesylate suppliers may include Nelfinavir Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Nelfinavir Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nelfinavir Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nelfinavir Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Nelfinavir Mesylate DMFs exist exist since differing nations have different regulations, such as Nelfinavir Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nelfinavir Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Nelfinavir Mesylate USDMF includes data on Nelfinavir Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nelfinavir Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nelfinavir Mesylate suppliers with USDMF on PharmaCompass.
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