USFDA withholds product approval from Alkem's US facility

Alkem Laboratories on Friday informed the exchanges that it has received a letter from the US Food and Drug Administration directing it to withhold the manufacturing of products till completion of final evaluation. Earlier, the USFDA had issued Form 483 with eight observations during a pre-approval inspection for a product at the company’s manufacturing facility located at St Louis, US. The final decision by the USFDA would be communicated to the company accordingly, it said. Shares of Alkem Laboratories closed 1.24 per cent lower at ₹1,730.45 on the BSE.