Gland Pharma shares jump 5% on zero observation from US FDA

A meeting of the board of directors of the company will be held on August 7, 2023, to consider and approve the unaudited standalone and consolidated financial results for the quarter ended June 30, 2023.

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The Gland Pharma share price was up 5.49 percent at Rs 1,365 at 9:23am on July 31 after the company received a zero-observation certificate from the US drug regulator for its Visakhapatnam facility.

The United States Food and Drug Administration (US FDA) conducted the good manufacturing practice (GMP) inspection at the company’s VSEZ Sterile Oncology facility at Visakhapatnam between July 20 and July 28. The inspection concluded with zero 483 observations and a classification of No Action Indicated (NAI).

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A meeting of the board of directors of the company will be held on August 7 to consider and approve the unaudited standalone and consolidated financial results for the quarter ended June 30.

On July 14, the company received one observation after the USFDA conducted a GMP inspection at Dundigal facility at Hyderabad during July 3-14.

The regulator had last month issued one observation on the company’s Pashamylaram facility at Hyderabad after GMP and pre-approval inspection (PAI) for seven products.