Sun Pharma Ramps Up USFDA Compliance Efforts at Key Plants

Sun Pharmaceutical Industries is working toward a complete regulatory resolution for three of its manufacturing facilities that are being reviewed by the US Food and Drug Administration (USFDA).

Sun Pharmaceutical has completed way of corrective and preventive actions (CAPA) for its Halol plant in Gujarat, which has an import alert and is awaiting a follow-up inspection. The Mohali plant in Punjab received a non-compliance letter and is in various stages of CAPA implementation. The Dadra plant received an Official Action Indicated (OAI) classification in FY24 and is in process of addressing several compliance issues.

Despite regulatory issues, Sun Pharma's remaining manufacturing sites in India are fully compliant with global manufacturing standards. The company reiterated its continued focus on quality system improvements at every level of all its units. From a business perspective, Sun Pharma is continuing to pivot to their global specialty portfolio. The global specialty portfolio made 20% of overall revenue in FY25 and was a 2% increase from FY24's 18% - the overall revenue for FY25 was Rs 52,041 crore and FY26 is expected to have mid-to-high single digit topline growth driven by specialty products and operational efficiencies.

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With R&D investment projected at 6–8% of sales in FY26, Sun Pharma is positioning itself to expand its footprint in complex therapies while simultaneously addressing regulatory expectations with a proactive long-term approach.