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