Gland Pharma gets EIR from USFDA for Pashamylaram facility

Gland Pharma announced that it has received an establishment inspection report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Pashamylaram facility at Hyderabad.

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 firms 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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