As per the exchange filing dated 25 February 2025, the USFDA had conducted a pre-approval inspection (PAI) for sterile APIs at the company’s facility located at JNPC, Visakhapatnam, between 19 February and 25 February 2025.
The inspection concluded with three Form 483 observations, which the company clarified were procedural in nature. The firm stated that these are not repeated observations and are unrelated to data integrity. The company intends to submit the required corrective and preventive actions (CAPA) to the USFDA within the stipulated timeline.
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's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24.