Lupin Slapped With Fresh FDA Warning Letter

Lupin has announced that the US FDA has slapped its Mandideep plant in central India with a warning letter after the company failed to fix compliance problems detected by inspectors in late 2018.

Warning
Lupin has received a further FDA warning • Source: Shutterstock

Lupin, which has been struggling to resolve regulatory compliance problems at its plants for years, has received another warning letter from the US Food and Drug Administration. This time, the warning letter concerns Lupin’s Mandideep Unit 1 facility in central India. The new FDA notice brings to three the number of Lupin plants under warning letters. 

Lupin told the Bombay Stock Exchange there were no drug master files or abbreviated new drug applications pending approval from...

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