Aurobindo Pharma trades in red despite FDA nod to Eugia Pharma injection

Aurobindo Pharma’s wholly owned subsidiary company, Eugia Pharma Specialities Limited received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg single-dose vial.

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Aurobindo Pharma was trading marginally in the red on January 4 amid weak market conditions. At 12:01 hrs Aurobindo Pharma was quoting at Rs 440.20, down Re 1, or 0.23 percent on BSE. It has touched an intraday high of Rs 445.00 and an intraday low of Rs 440.10.

In a BSE filing, the company announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg single-dose vial.

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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 USD 46 million for the twelve months ending November 2022, according to IQVIA, Aurobindo Pharma added.

“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,” the firm added.