01 1Catalent Pharma Solutions
01 1AMPRENAVIR 50 AND 150 MG SOFT GELATIN CAPSULES
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13060
Submission : 1998-07-07
Status : Inactive
Type : II
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PharmaCompass offers a list of Amprenavir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Amprenavir manufacturer or Amprenavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amprenavir manufacturer or Amprenavir supplier.
A AMV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMV, including repackagers and relabelers. The FDA regulates AMV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMV 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 AMV supplier is an individual or a company that provides AMV active pharmaceutical ingredient (API) or AMV finished formulations upon request. The AMV suppliers may include AMV API manufacturers, exporters, distributors and traders.
click here to find a list of AMV suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AMV DMF (Drug Master File) is a document detailing the whole manufacturing process of AMV active pharmaceutical ingredient (API) in detail. Different forms of AMV DMFs exist exist since differing nations have different regulations, such as AMV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMV DMF submitted to regulatory agencies in the US is known as a USDMF. AMV USDMF includes data on AMV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMV suppliers with USDMF on PharmaCompass.
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