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Gland Pharma Soars 5% On Zero Observation from USFDA

These injection sales in the US are approximately $92 million for twelve months.

On July 31, Gland Pharma’s share price surged 5.49% to Rs 1,365 after the company acknowledged a zero-observation certificate from the US drug regulator for its Visakhapatnam capability.

The United States Food and Drug Administration (US FDA) showed a good manufacturing practice (GMP) inspection at the business’s VSEZ Sterile Oncology facility in Visakhapatnam between July 20 and July 28. The inspection was determined with zero 483 observations and No Action Indicated (NAI) classification.
A meeting of the company’s board of directors will be held on August 7 to deliberate and approve the unaudited standalone and combined financial results for the quarter ended June 30.
On July 14, the company acknowledged one observation after the USFDA showed a GMP inspection at the Dundigal unit at Hyderabad during July 3-14.
Earlier this month, the regulator delivered one observation on the company’s Pashamylaram unit at Hyderabad after GMP and pre-approval inspection (PAI) for seven products.

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