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
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PharmaCompass offers a list of Indinavir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Indinavir manufacturer or Indinavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indinavir manufacturer or Indinavir supplier.
PharmaCompass also assists you with knowing the Indinavir API Price utilized in the formulation of products. Indinavir API Price is not always fixed or binding as the Indinavir Price is obtained through a variety of data sources. The Indinavir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A IDV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IDV, including repackagers and relabelers. The FDA regulates IDV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IDV 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 IDV supplier is an individual or a company that provides IDV active pharmaceutical ingredient (API) or IDV finished formulations upon request. The IDV suppliers may include IDV API manufacturers, exporters, distributors and traders.
click here to find a list of IDV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A IDV DMF (Drug Master File) is a document detailing the whole manufacturing process of IDV active pharmaceutical ingredient (API) in detail. Different forms of IDV DMFs exist exist since differing nations have different regulations, such as IDV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A IDV DMF submitted to regulatory agencies in the US is known as a USDMF. IDV USDMF includes data on IDV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The IDV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of IDV suppliers with USDMF on PharmaCompass.
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