Gland Pharma gets EIR from USFDA for Dundigal facility

Gland Pharma informed that it has received establishment inspection report (EIR) from the US drug regulator for its Dundigal facility in Hyderabad, indicating closure of the inspection.

The United States Food and Drug Administration (USFDA) conducted a surprise inspection of the companys Dundigal Facility for good manufacturing practices (GMP) between 22 July 2024 and 25 July 2024.

Earlier, on 25 July, the durg maker stated that the inspection was concluded with 2 483 observations. These observations were procedural in nature and also were neither repeated observations nor related to data integrity. Now, the company has received an EIR from the USFDA stating closure of the inspection.

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 0.24% to currently trade at Rs 1,676.75 on the BSE.

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