Gland Pharma Share Price Rises as Investors Disregard USFDA Issue

28 Jun 2023 , 01:12 PM

Gland Pharma’s share price saw a 1% increase in early trade on June 28, as investors appeared to overlook the concerns raised by the US Food and Drug Administration (USFDA) regarding the company’s Hyderabad facility.

The US health regulator conducted a pre-approval inspection (PAI) for seven products and assessed the good manufacturing practices (GMP) at Gland Pharma’s Pashamylaram facility in Hyderabad between June 15 and June 27, 2023, according to a statement by the company.

Following the inspection, one observation in the form of a 483 was issued. However, Gland Pharma clarified that the observation was procedural in nature and not related to data integrity. The company stated that the necessary corrective actions would be submitted to the USFDA within the specified timeframe.

Importantly, the observation was not a recurring issue and did not pertain to any concerns regarding data integrity, highlighting the company’s commitment to maintaining quality standards. Despite the USFDA observation, investors remained positive about Gland Pharma’s prospects, leading to a rise in the share price.

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