Gland Pharma Ltd News Today

The FDA conducted the pre-approval inspection (PAI) from Feb. 19, 2025, to Feb. 25, 2025, as part of the regulatory process for sterile APIs.

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EBITDA (Earnings Before Interest, Tax, Depreciation, and Amortization) increased by 1% YoY to ₹360 crore, compared to ₹356.4 crore in the previous year.

Sintilimab is marketed in China as TYVYT (sintilimab injectable) and was co-developed by Innovent and Eli Lilly.

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Gland Pharma stock has gained a total of 12% in the last one year, and 7.37% dip since the beginning of the year.

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The inspection concluded with three 483 observations. Gland Pharma clarified that these observations are procedural and not related to data integrity or repeat issues.