Aurobindo Pharma’s wholly owned subsidiary -- Eugia Pharma Specialities has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg Single-Dose Vial. Azacitidine for Injection, 100 mg Single-Dose Vial, to be bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vidaza for Injection, 100 mg Single-Dose Vial, of Bristol-Myers Squibb Company. The product is expected to be launched by this month. The approved product has an estimated market size of around $46 million for the twelve months ending November 2022, according to IQVIA.
This is the 153rd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
