IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Generic Drug Fees: A Fantastic Oppprtunity

7:13 AM MDT | September 1, 2011 |

Girish Malhotra

The U.S. FDA has created a fantastic opportunity for incorporating the best manufacturing technologies in the pharmaceutical hemisphere by charging fees to every generic company globally. The carrot of early approval - if that happens - will be a driver to have the best processes for active pharmaceutical ingredient (API) and formulation if the companies want to produce repeatable quality and safe drugs. Early approvals also will mean quicker profits compared to the current status. It would be a win-win.  Early approval will require that processes meet the...

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