Gland Pharma shares rise most in 16 weeks, with US FDA's pre-approval inspection at its JNPC facility

Shares of Gland Pharma gained about 5 percent on February 25, clocking its best day in 16 weeks, ahead of its investor meet on Feb 27-28 during the analyst day with Emkay and BoB Capital. This comes following the United States Food and Drug Administration (US FDA)
Pre-approval inspection (PAI) for Sterile APIs at the Company’s Facility at JNPC, Visakhapatnam between February 19, 2025 and February 25, 2025.

The inspection concluded with three (3) Form 483 observations, which are procedural in nature. Corrective and preventive actions for these observations will be submitted to the US FDA within the required timeframe. These observations are not repeats and are unrelated to data integrity issues.

Business daily Livemint had reported earlier this in February citing sources that Blackstone, Brookfield, and Warburg Pincus were in talks to acquire a majority stake in Gland Pharma, a maker of generic injectables. The deal, involving three global private equity majors and Shanghai-based Fosun Pharma - which holds a majority stake - is expected to value Gland Pharma at approximately $3 billion.

Gland Pharma's performance for the December quarter has been underwhelming, with weak revenue growth in its core business. The injectables company also faced challenges from its recently acquired Cenexi business, which weighed on its performance. Gland Pharma anticipates a recovery in its core business in Q4FY25 but has extended the breakeven timeline for Cenexi by another year.