Sun Pharma Addresses USFDA Issues at 3 Plants

New Delhi, Jul 7 (PTI) Drug major Sun Pharmaceutical Industries aims to bolster compliance across its manufacturing operations and work towards achieving full regulatory resolution at the three facilities facing USFDA action, according to Chairman and MD Dilip Shanghvi.

In his address to shareholders in its annual report for 2024-25, Shanghvi said the company is facing US Food and Drug Administration (USFDA) compliance-related issues at three of its facilities.

The company is facing an import alert for the Halol facility and also is in receipt of non-compliance letter for the Mohali facility, he stated.

Additionally, the company's Dadra facility was accorded an Official Action Indicated (OAI) status in FY24, he noted.

"We have completed the implementation of Corrective and Preventive Action (CAPA) in the Halol facility, which is currently awaiting USFDA inspection, and we are in the process of implementing CAPA at the Mohali and Dadra facilities," he added.

Besides these three, all facilities remain compliant with global regulatory standards, including those of the US FDA, Shanghvi said.

On the business front, he noted the company expects its R&D investment to be in the range of 6-8 per cent of sales in the current financial year, with enhanced focus on speciality products.


The company aims to expand its product pipeline of global speciality products, he added.

"Our R&D spend in FY26 is likely to be in the range of 6-8 per cent of sales, with increased spending expected on speciality products," Shanghvi stated.

The Mumbai-based drug major invested USD 154 million on speciality products R&D in FY25.

Sun Pharma reported consolidated revenues of Rs 52,041 crore in FY25, with the share of global speciality business increasing from 18 per cent in FY24 to 20 per cent in FY25 sales.

The company sells speciality products like Ilumya, Winlevi, Cequa and Odomzo across markets.

"We anticipate mid to high single-digit consolidated topline growth in FY26, and expect our global speciality business to continue on its growth path," Shanghvi said.

Elaborating on the focus areas, he said the company plans to prepare the business for potential disruptions arising from tariffs and geopolitical issues.

The company would also continue to focus on cost and operational efficiency, he added.