Gland Pharma Hyderabad facility gets 1 observation from USFDA; stock gains 3%

The inspection was concluded with one 483 Observation.

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Gland Pharma share price rose 3.5 percent intraday on July 14 despite the United States Food and Drug Administration (US FDA) issuing one observation for its Hyderabad facility.

The United States Food and Drug Administration (US FDA) conducted Good Manufacturing Practice (GMP) Inspection at Gland Pharma‘s Dundigal facility in Hyderabad between July 3 and July 14, 2023.

The inspection was concluded with one 483 observation.

The corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity, said company.

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In the month of June, USFDA conducted a pre-approval inspection (PAI) for seven products and Good Manufacturing Practice (GMP) inspection at the company’s Pashamylaram facility in Hyderabad between June 15 and June 27, 2023.

This observation was procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity, the drugmaker said.