Eugia Pharma Specialities Ltd receives USFDA final approval Lenalidomide Capsules

Aurobindo Pharma Limited has announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, which is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Revlimid Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company. The product is expected to be launched in October 2023 (Volume specific launch).

This is the 155th ANDA (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 466.50 as compared to the previous close of Rs. 460.15. The total number of shares traded during the day was 63781 in over 2662 trades.

The stock hit an intraday high of Rs. 473.85 and intraday low of 460.00. The net turnover during the day was Rs. 29933882.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 Pharmaceuticals FinalApproval USFDA LenalidomideCapsules