U.S. FDA inspected Sun Pharma’s facility in Baska, Gujarat, from September 8 to 19. File
| Photo Credit: Reuters
Shares of Sun Pharmaceutical Industries closed 2.77% lower on Thursday (December 18, 2025) at ₹1,745.35 apiece on the BSE after the U.S. Food and Drug Administration (U.S. FDA) classified the company’s facility in Baska, Gujarat, as Official Action Indicated (OAI) following the inspection it conducted from September 8 to 19.
The OAI status implies regulatory and/or administrative actions are recommended.
“We continue to manufacture and supply approved products from the facility to the U.S. market… will work with the regulator to achieve fully compliant status,” the company said.
The OAI is one of three classifications the U.S. FDA issues after inspecting facilities. Voluntary Action Indicated (VAI) is another, which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. No action indicated (NAI) is the third classification which means no objectionable conditions or practices were found during the inspection.
Published – December 18, 2025 08:30 pm IST
