US FDA flags Sun Pharma Baska plant with OAI

Sun Pharmaceutical Industries Ltd on Thursday said the US Food and Drug Administration (FDA) has classified its Baska manufacturing facility under Official Action Indicated (OAI) following a recent inspection, even as the company said supplies to the US market from the plant will continue.In an exchange filing, Sun Pharma said, “This is to inform that the US FDA conducted an inspection at the Company’s Baska 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).”The drugmaker, however, sought to reassure investors on business continuity. “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 the filing.According to the US FDA, inspection classifications fall into three categories. Official Action Indicated (OAI) means that regulatory and/or administrative actions are recommended based on the agency’s inspection findings.The regulatory update comes against the backdrop of heightened investor focus on Sun Pharma’s overseas manufacturing footprint, particularly as the company pursues export-led opportunities in high-value therapies. Last week, the Delhi High Court allowed Sun Pharma to manufacture its version of the diabetes and anti-obesity drug semaglutide in India and export it, while restraining domestic sales until March 2026, when Danish drugmaker Novo Nordisk’s secondary patent expires.Justice Manmeet Pritam Singh Arora permitted exports but barred sales in the Indian market, directing Sun Pharma to file an affidavit within two weeks and submit export-related account details. The matter is scheduled for further hearing on February 19. Sun Pharma’s shares were trading at Rs 1,778.20, up 0.12%, following the court’s order.Novo Nordisk had moved the High Court seeking to restrain Sun Pharma from manufacturing and selling semaglutide, alleging patent infringement of its blockbuster weight-loss drug sold under the brand name Wegovy. The Danish drugmaker continues to hold a secondary patent in India related to specific formulations and delivery mechanisms of semaglutide, valid until March 2026, even though its primary compound patent expired in September 2024--an expiry that has opened the door for Indian drugmakers to pursue export-focused generic versions.