Sun Pharma shares drop over 3% as USFDA issues OAI status for Dadra facility

Shares of Sun Pharmaceutical Industries declined over 3% during the morning session on Friday, April 12, on the NSE, following USFDA’s classification of the company’s Dadra facility as Official Action Indicated (OAI).

The OAI status by the United States Food and Drug Administration (USFDA) signifies that regulatory or administrative actions have been advised.

The US drug regulator conducted the inspection at the Dadra facility of the pharma major in December 2023, the company informed in a stock exchange filing.

“The USFDA conducted an inspection at the Company's Dadra facility from December 4, 2023 to December 15, 2023. The USFDA has subsequently determined the inspection classification status of this facility as Official Action Indicated (OAI),” Sun Pharma said.

The company informed the stock exchanges that it will work with the US regulator to achieve fully compliant status.

Sun Pharma shares opened lower at ₹1,595 apiece on the NSE on Friday and further tanked 3.5% to a low of ₹1,546.45 apiece. The stock, however, recovered some losses to trade 3.9% lower at ₹1,539.6 apiece at 13:15 pm.

This development comes on the heels of a setback a month ago when Sun Pharma had to recall around 55,000 bottles of a generic medication used to treat gout from the American market due to deviations from manufacturing practice norms. The recall pertained to Febuxostat Tablets in 40 mg and 80 mg strengths, as detailed in the Enforcement Report by the USFDA.

Sun Pharmaceutical Industries’ hit its 52-week high on April 5, 2024, when the stock traded at ₹1,638.85, while its 52-week low was recorded on May 18, 2023, with the stock trading at ₹922.45 apiece on the NSE.