
The European business reported a 54 percent year on year surge in topline during the quarter.

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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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