US FDA issues 3 Form 483 observations to Gland Pharma's Pashamylaram facility

Gland Pharma said that the United States Food and Drug Administration (US FDA) has conducted an un-announced inspection of the company's Pashamylaram Facility at Hyderabad for good manufacturing practices (GMP).

The said inspection was conducted between 25 July 2024 and 02 August 2024.

The said inspection was concluded with three Form 483 Observations.

"These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity, the company said in a statement.

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 pharma company reported a consolidated net profit of Rs 192.42 crore in Q4 FY24, steeply higher than Rs 78.68 crore posted in Q4 FY23. Revenue from operations soared 95.85% to Rs 1,537.5 crore during the quarter as against Rs 785.01 crore recorded in Q4 FY23.

The scrip fell 2.52% to currently trade at Rs 2074.10 on the BSE.

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