India's largest drug maker Sun Pharmaceutical Industries said its Halol manufacturing site in Gujarat had been classified as Official Action Indicated (OAI) by USFDA.
The OAI status implies that the USFDA may put all new approvals from the Halol facility on hold till the outstanding corrective actions are completed.
Sun Pharma will be able to manufacture and supply already-approved products from the facility to the US market.
Shares of the company declined Rs 4.5, or 1.33%, to settle at Rs 333.65. The total volume of shares traded was 270,092 at the BSE (Monday).