01 1Fujifilm Diosynth Biotechnologies
01 1TRENBOLONE ACETATE
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16347
Submission : 2003-01-03
Status : Inactive
Type : II
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A Finaplix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Finaplix, including repackagers and relabelers. The FDA regulates Finaplix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Finaplix API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Finaplix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Finaplix supplier is an individual or a company that provides Finaplix active pharmaceutical ingredient (API) or Finaplix finished formulations upon request. The Finaplix suppliers may include Finaplix API manufacturers, exporters, distributors and traders.
click here to find a list of Finaplix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Finaplix DMF (Drug Master File) is a document detailing the whole manufacturing process of Finaplix active pharmaceutical ingredient (API) in detail. Different forms of Finaplix DMFs exist exist since differing nations have different regulations, such as Finaplix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Finaplix DMF submitted to regulatory agencies in the US is known as a USDMF. Finaplix USDMF includes data on Finaplix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Finaplix USDMF is kept confidential to protect the manufacturer’s intellectual property.
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