01 1Aurobindo Pharma Limited
02 1Viatris
01 1INDINAVIR SULFATE USP
02 1INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE)
01 1India
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19851
Submission : 2006-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18495
Submission : 2005-07-12
Status : Inactive
Type : II
A Indinavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indinavir, including repackagers and relabelers. The FDA regulates Indinavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indinavir 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 Indinavir supplier is an individual or a company that provides Indinavir active pharmaceutical ingredient (API) or Indinavir finished formulations upon request. The Indinavir suppliers may include Indinavir API manufacturers, exporters, distributors and traders.
click here to find a list of Indinavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indinavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Indinavir active pharmaceutical ingredient (API) in detail. Different forms of Indinavir DMFs exist exist since differing nations have different regulations, such as Indinavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indinavir DMF submitted to regulatory agencies in the US is known as a USDMF. Indinavir USDMF includes data on Indinavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indinavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indinavir suppliers with USDMF on PharmaCompass.
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