Sun Site Stares At FDA Action But Dent May Be Limited

 
• By Anju Ghangurde
  
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FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.

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Halol unit fails to make FDA compliance cut • Source: Shutterstock

Sun Pharmaceutical Industries Ltd.’s Halol site has failed to make the compliance cut, bringing back unpleasant memories of protracted enforcement action some years ago by the US Food and Drug Administration. The key difference this time round, however, appears to be that the facility is now less critical to the Indian firm’s operations following concerted risk mitigation efforts over the years that included shifting products filings to alternative sites.

Sun said the FDA had indicated that the Halol facility has been classified as "Official Action Indicated (OAI)" which it...

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