Mumbai: Sun Pharmaceutical Industries Ltd on Tuesday said the US Food and Drug Administration (US FDA) has classified its Halol facility in Gujarat as “Official Action Indicated” (OAI), following an inspection conducted between June 2 and June 13, 2025.
The facility, already under import alert, will continue to face restrictions, with shipments to the US refused except for products exempted due to shortage considerations.
The company noted that the classification reflects non-compliance with certain current good manufacturing practices (cGMP). “Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally,” the company said in a statement.
The development comes as the stock closed at ₹1,594 on the NSE, up 0.82%.
In late August, BofA Securities downgraded Sun Pharma to “underperform” from “neutral” and cut its price target to ₹1,570, citing valuation concerns and risks to consensus earnings estimates.
India’s largest drugmaker had reported a mixed June quarter, with consolidated revenue of ₹13,821 crore, EBITDA rising 19.2% year-on-year to ₹4,302 crore, and margins expanding to 31%. Net profit, however, slipped to ₹3,172.7 crore due to a one-time charge of ₹818 crore.
