In a regulatory filing made during market hours today, the injectibles maker said that the United States Food and Drug Administration (US FDA) had conducted good manufacturing practice (GMP) inspection at the company's Dundigal Facility at Hyderabad between 03 July 2023 and 14 July 2023.

The inspection was concluded with ONE (1) 483 Observation. The corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period.

"The observation issued is neither a repeated observation nor related to data integrity,” Gland Pharma said in a statement.

Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.

The company reported 72% drop in net profit to Rs 78.7 crore in Q4 FY23 from Rs 285.9 crore in Q4 FY22. Revenue from operations fell by 29% YoY to Rs 785 crore during the quarter.