Eugia Pharma receives USFDA approval for Azacitidine for Injection

Aurobindo Pharma Limited's wholly owned subsidiary company, Eugia Pharma Specialities Limited, 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 US$ 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.

- Indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes:

- Refractory Anemia (RA) or Refractory Anemia with Ringed Sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions),

- Refractory Anemia with Excess Blasts (RAEB),

- Refractory Anemia with Excess Blasts in Transformation (RAEB-T),

- Chronic Myelomonocytic Leukemia (CMMoL).

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 441.20 as compared to the previous close of Rs. 434.65. The total number of shares traded during the day was 45342 in over 1527 trades.

The stock hit an intraday high of Rs. 447.25 and intraday low of 433.70. The net turnover during the day was Rs. 20029576.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals EugiaPharmaSpecialities FinalApproval USFDA Azacitidine Injection