U.S. Food and Drug Administration (USFDA) has conducted an inspection at Sun Pharmaceutical Industries’ Baska facility from September 08, 2025 to September 19, 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI).
The company continues to manufacture and supply approved products from the facility to the US market. The company will work with the regulator to achieve fully compliant status.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
