Pharma company Sun Pharmaceutical Industries is planning to strengthen compliance across its manufacturing units and is working towards fully resolving regulatory issues at the three facilities currently under USFDA scrutiny, Chairman and MD Dilip Shanghvi said while addressing shareholders in the company’s annual report for 2024-25,
Compliance-related issues
Shanghvi said the company is facing USFDA compliance-related issues at three of its facilities. These include an import alert at the Halol facility, receipt of non-compliance letter for the Mohali facility, both during FY23. Additionally, its Dadra facility was accorded an Official Action Indicated (OAI) status in FY24.
“We have completed the implementation of Corrective and Preventive Action (CAPA) in the Halol facility, which is currently awaiting US FDA inspection, and we are in the process of implementing CAPA at the Mohali and Dadra facilities,” Shanghvi said.
Besides these three, all of the facilities, he added, remain compliant with global regulatory standards, including those of USFDA.
Focus on Specialty, R&D to drive growth
In terms of business, the company CMD said, Sun Pharma will invest 6.2 per cent as percentage of total sales in FY25. “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 Specialty products,” he added.
During FY25, Sanghvi said, “Our global consolidated revenues grew by 9.0 per cent to Rs 520 billion, while EBITDA grew by 17.3 per cent to Rs 153 billion. Adjusted net profit was up by 19.0 per cent to Rs 120 billion. Our return ratios also continued their upward trend.”
On Specialty products, he maintained, the global specialty revenue posted a 17.1 per cent growth to reach $1,216 million during FY25. “Key products such as Ilumya, Winlevi, Cequa and Odomzo continued to perform well globally. FY25 also proved to be an eventful year in terms of enhancing our Specialty pipeline,” he added.
In the US, Sun Pharma’s revenue went up by 5.8 per cent to Rs 162 billion, accounting for approximately 31 per cent of the consolidated revenues. “Our growth in the US has been driven by Specialty sales, with several products gaining sustained traction,” Sanghvi said. He, however, maintained that the generics business in the US was adversely affected by the ongoing compliance issues at the company’s manufacturing facilities.
Shares of Sun Pharma were down 1.19 per cent at 10:50 am today at a trading price of Rs 1,659.85.