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The Pashamylaram facility received an EIR, which indicates closure of the inspection, Gland Pharma said in a filing.
The USFDA inspected the facility between 25 July 2024 and 2 August 2024 for good manufacturing practices (GMP) and issued three Form 483 observations. These observations were procedural in nature.
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.
On a consolidated basis, the firm’s net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24.
The scrip rose 0.10% to settle at Rs 1,678.95 on Friday, 18 January 2025.
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