5-FLUOROURACIL

drug master file held by dcs pharma

EU-GMP, CEP AND COMPLETE DMF/US-DMF AVAILABLE

5-FU (CAS 51-21-8) – also known as FLUOROURACIL - is a pyrimidine analog used in the treatment of cancer. It is a suicide inhibitor and works through irreversible inhibition of thymidylate synthase. It belongs to the family of antimetabolites.

THERAPEUTIC INDICATION: ONCOLOGY

5-Fluorouracil is one of the most prescribed cytostatics used mainly for the treatment of colorectal and breast cancer.

MARKET INFORMATION

Originator: HOFFMANN LA ROCHE
Core patent exclusivities: 1962 off patent

YOUR ADVANTAGES   

  • DCS Pharma is the DMF holder 
  • We organize the supply chain of the starting material 2EFU and the packaging material.
  • EU-GMP, CEP and full DMF, US-DMF

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