The American drug regulator had inspected the company’s facility from 8 September 2025 to 19 September 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI).

“We continue to manufacture and supply approved products from the facility to the US market. We will work with the regulator to achieve fully compliant status,” the company said in a statement.

Sun Pharmaceutical Industries is the world’s leading specialty generics company with a presence in innovative medicines, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as global emerging markets.

The company had reported 2.6% rise in consolidated net profit to Rs 3,118 crore on a 8.6% increase in revenue to Rs 14,405.2 crore in Q2 FY26 as compared with Q2 FY25.