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