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The drug regulator conducted the PAI inspection for seven products as well as GMP inspection and issued one observation.
The company stated that this observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity.
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.
The scrip rose 0.81% to Rs 1022.80 on the BSE.
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