Sun Pharma gets USFDA warning for manufacturing practice violations at Dadra unit; stock extends fall

Sun Pharma gets USFDA warning letter for Dadra unit

Sun Pharmaceutical Industries Ltd has got a warning letter from the United States Food and Drug Administration (USFDA) for its Dadra facility, the company said in a stock exchange filing. The warning letter summarises violations with respect to Current Good Manufacturing Practice (cGMP)
regulations, said the pharma major.

The warning letter weighed on Sun Pharma stock, which fell nearly 2 percent to Rs 1,475 on June 20, extending the previous session's fall. On June 19, the stock had fallen more than 1 percent, underperforming benchmark Nifty 50, which ended down 0.15 percent.

Earlier, in April, Sun Pharma had received an Official Action Indicated (OAI) status for its Dadra unit from the USFDA. The US regulator had inspected the facility in December, 2023. The OAI status means that the company or its facilities could face regulatory or administrative curbs.

"We are concerned about the negative outcomes in the audit and I think its our job to find a way to ensure that we come out of whatever the learnings that we have so that we perform better in subsequent audits," Sun Pharma Chairman and Managing Director Dilip Shanghvi had said during its recent earnings call with analysts.

Sun Pharma's Dadra unit is involved in the production of oral solid dosage forms and in the manufacturing of the generic Revlimid. The drug has been a key driver of sales for many pharma companies including Dr Reddy's.

"We have done enough corrections so that we should see a positive outcome in subsequent audits," Shanghvi had said during the earnings call.