Sun Pharma shares under pressure after the USFDA flags a key unit

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HomeMarket NewsSun Pharma shares under pressure after the USFDA flags a key unit

Sun Pharma said it continues to manufacture and supply approved products from the facility to the US market.

By Meghna Sen  December 18, 2025, 10:19:56 AM IST (Published)

Shares of Sun Pharmaceutical Industries Ltd. are trading 2.4% lower on Thursday, December 18, after the US Food and Drug Administration classified the company's Baska facility as an Official Action Indicated, or OAI.

The Baska plant was inspected by the US health regulator between September 8 and September 19, 2025. Sun Pharma said it continues to manufacture and supply approved products from the facility to the US market.

Analysts said that Baska is among Sun Pharma's most critical plants, particularly for new complex generics. With the OAI classification, the probability of a positive surprise from the company's generic business could be lower.

However, analysts add that the OAI does not impact current forecasts, as contributions from new complex generics are not factored into estimates yet.

Meanwhile, other Sun Pharma facilities remain under regulatory scrutiny. The Halol plant has been under import alert since June 2022 and was classified as OAI following a June 2025 inspection. The Mohali facility received a consent decree or non compliance letter in 2023.

The Mumbai-based drugmaker expects its India business to continue growing ahead of the market, led by a strong focus on key therapies and brand building, Chief Financial Officer Jayashree Satagopan told CNBC-TV18 last month.

"We have been focused on certain therapies and building strong brands," Satagopan said, citing that consistent engagement with doctors and an expanded sales force have helped sustain growth. "Our intent is to grow the business slightly ahead of the market even in the coming quarters."

On margins, Satagopan refrained from giving product-level guidance but said R&D spending will remain within the company's target range. "We may end up at the lower end of our guidance, around 6% of sales," she said, adding that ongoing clinical trials are progressing as planned.

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