Aurobindo Pharma arm gets USFDA nod for cancer drug

The pharmaceutical company on Wednesday announced that its wholly owned subsidiary, Eugia Pharma Specialities has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lenalidomide Capsules.

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone. The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revlimid Capsules, of Bristol-Myers Squibb Company.

The drug maker said that 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 company reported 18.8% decline in consolidated net profit to Rs 491.26 crore in Q3 FY23 as against Rs 604.73 crore reported in Q3 FY22. Revenue from operations rose 6.7% year on year to Rs 6,387.97 crore in the quarter ended 31 December 2022.

Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.

Shares of Aurobindo Pharma were up 0.33% to Rs 468.05 on the BSE.

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