FDA clears Lupin's Aurangabad, Mandideep plants

Earlier, both the plants had received adverse observations from the US drug regulator

Drug maker Lupin announced today that the US Food and Drugs Administration has cleared its facilities at Mandideep and Aurangabad following its audit.

Both the plants had received adverse observations from the US drug regulator during inspections in January and February.

Lupin said it has taken appropriate steps to address the regulator's observations and now both the plants are compliant on current good manufacturing practices.

US market contributes to over 40% of Lupin's business and the company expects to grow the business further with launch of new products from its US subsidiary Gavis and contribution from anti diabetes drug Glumetza for which it has 180 day sale exclusivity.

 

However the company's Goa plant continues to be under FDA scanner and the company expects to close the findings in next 3-6 months.