Aurobindo Pharma Limited is pleased to announce 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.

Aurobindo Pharma has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti- Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.