Sun Pharma shares slip 3% after US FDA flags Baska manufacturing facility

Sun Pharma's Baska plant in Gujarat receives OAI status from the US FDA after inspection, adding near-term regulatory uncertainty but not impacting current US supplies

Sun Pharmaceutical on Thursday informed stock exchanges that the US Food and Drug Administration (US FDA) has classified its Baska manufacturing facility in Gujarat as Official Action Indicated (OAI) following an inspection conducted between September 8 and September 19, 2025.

 

In a regulatory filing under Regulation 30 of the Sebi (Listing Obligations and Disclosure Requirements) Regulations, 2015, the country’s largest drugmaker said the inspection outcome does not impact current manufacturing or supplies to the US market. 

“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. 

An OAI classification indicates that the regulator has identified significant compliance issues that may warrant further regulatory action. However, Sun Pharma has maintained that it will engage with the US FDA to address the observations and restore full compliance at the facility.

 

Market reaction to the disclosure was negative, with Sun Pharma shares declining 2.7 per cent on Thursday to close at Rs 1,745.35 apiece.

 

Analysts said the development adds a layer of regulatory uncertainty in the near term, though the financial impact is expected to be limited.

 

Nirali Shah, pharma analyst at Ashika Group, said the OAI status represents a regulatory setback and could increase uncertainty around future product filings and approvals linked to the Baska site. “While current manufacturing and US supplies remain unaffected, remediation timelines, the risk of repeat inspections, and potential regulatory escalation create a near-term compliance overhang,” she said.

 

According to Shah, the exposure appears manageable as the Baska facility is understood to contribute marginally to Sun Pharma’s overall supply base. “Overall, this remains a monitorable regulatory risk rather than an operational disruption,” she added.