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The receipt of the EIR marks the formal closure of the US health regulator’s pre-approval inspection, which was conducted between February 19 and February 25, 2025.
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Gland Pharma also established that its version is bioequivalent and therapeutically equivalent to the reference listed drug.
Gland Pharma net profit was at ₹186.5 crore as against ₹192.4 crore in the year-ago quarter of FY24.
Gland Pharma has secured exclusive rights as the first-to-file sponsor of this generic product. This makes it eligible for 180 days of marketing exclusivity in the US
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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