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