The FDA found the facility not fully compliant with current Good Manufacturing Practices (CGMP).
Halol is one of Sun Pharma’s key plants but has been under an import alert since December 2022, leading to the refusal of shipments from the site into the US, except for certain exempted products in cases of drug shortages.
The company had earlier received a warning letter for the Halol facility.
Compliance with FDA and CGMP standards is required before shipments can resume.
Recently, BofA Securities downgraded Sun Pharma to ‘Underperform’ from its earlier rating of ‘Neutral’, and slashed the price target to ₹1,570 from ₹1,730.
The downgrade was driven by two key concerns: a potential risk to consensus earnings and premium valuations.
Although Sun Pharma’s earnings, driven by its specialty portfolio, offer medium-term visibility, BofA expects only a gradual ramp-up from its new launches, falling short of market expectations.
The brokerage also said that while Sun Pharma may continue to pursue M&A activity in the specialty space, the upside is already priced in, with a downside risk if the recently acquired or launched specialty assets fail to scale as anticipated.
Additionally, Most Favoured Nation (MFN)-related newsflow continues to weigh on Ilumya, the company’s largest specialty drug, according to BofA.
Shares of Sun Pharma settled 0.82% higher on Tuesday at ₹1,594. However, the stock is down 16% year-to-date in 2025.
