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Gland Pharma Shares Plunged as Investors Brush Aside USFDA Issue

After the inspection, the USFDA issued a Form 483 with two observations.

On June 28, Gland Pharma’s share price rose 1% in the early trade as investors took the US Food and Drug Administration’s (USFDA) concerns about the firm’s Hyderabad facility.


The US health regulator directed a pre-approval inspection (PAI) for seven products and good manufacturing practices (GMP) at the business’s Pashamylaram Hyderabad unit between June 15, 2023, and June 27.

The inspection was determined with one 483 observation. The observation was technical, and the corrective actions were submitted to the USFDA within the specified period. The observation issued was neither a recurrent observation nor related to data integrity.


At 9:46 am, Gland Pharma was trading at Rs 1,025.00, up Rs 10.40, or 1.03% on the BSE. The share moved a 52-week high of Rs 2,718 on June 30, 2022, and a 52-week low of Rs 861.50 on May 22, 2023.
It trades 62.29% below its 52-week high and 18.98% above its 52-week low.

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