Mumbai – As regulatory scrutiny intensifies, Sun Pharmaceutical Industries is accelerating efforts to resolve compliance issues at its manufacturing facilities in Halol, Mohali, and Dadra, all of which have come under the radar of the US Food and Drug Administration (USFDA).
In the company’s recently released 2024–25 Annual Report, Chairman and Managing Director Dilip Shanghvi reaffirmed Sun Pharma’s commitment to strengthening quality standards and meeting global regulatory expectations.
Facilities Under Regulatory Lens
Three critical manufacturing units are currently under compliance watch:
- Halol (Gujarat): Under import alert status
- Mohali (Punjab): Received non-compliance letter during FY23
- Dadra (UT of Dadra and Nagar Haveli): Placed under Official Action Indicated (OAI) status in FY24
“We’ve completed CAPA implementation at Halol and are awaiting re-inspection by the USFDA. CAPA processes are also underway at Mohali and Dadra,” said Shanghvi.
Aside from these units, all other Sun Pharma sites remain compliant with USFDA and other international regulatory frameworks.
Strategic Insights for Pharma Leaders
For pharmaceutical professionals, Sun Pharma’s proactive compliance approach underscores a broader shift in global audit preparedness. The company’s increased transparency on CAPA timelines, and alignment with regulatory milestones, signals a growing industry trend toward early risk mitigation and systemic quality fortification.
Regulatory and quality heads at pharma companies can view this as a playbook for managing multi-site compliance risk under USFDA surveillance.
Doubling Down on R&D and Specialty Segments
Sun Pharma is not only focused on compliance but is also channeling significant resources into R&D and Specialty pharma to future-proof growth. Key highlights include:
- FY25 R&D spending at 6.2% of total sales
- Projected R&D investments for FY26 to rise to 6–8%, primarily in Specialty drug development
- FY25 global Specialty revenue hit $1,216 million, marking a 17.1% YoY growth
“Flagship Specialty brands like Ilumya, Winlevi, Cequa, and Odomzo have shown sustained performance,” Shanghvi added.
US Market: Compliance Challenges vs Specialty Momentum
The United States remains a critical geography, contributing approximately 31% of Sun Pharma’s consolidated revenue, which stood at ₹520 billion for FY25. While the Specialty business continues to thrive, the company noted that generics growth in the US was hampered by the operational impact of the compliance issues.
“Despite regulatory headwinds, US revenue grew by 5.8% to ₹162 billion—driven primarily by robust Specialty sales,” noted Shanghvi.
This reflects a larger market trend where innovative portfolios are cushioning regulatory disruptions in legacy generics.
Industry Takeaway
Sun Pharma’s strategic posture offers several cues for pharma professionals:
- CAPA transparency is key to regaining regulatory trust
- Specialty and innovation pipelines can hedge against compliance-related business disruptions
- Balanced geographic growth, even amid FDA scrutiny, is achievable with robust internal systems
As Indian pharma expands its global footprint, investments in regulatory resilience and specialty-driven R&D will be crucial to sustaining leadership.