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Aurobindo Pharma Trades in Red Despite FDA Approval of Eugia Pharma Injection

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Aurobindo Pharma posted a small loss on January 4 amid weaker markets. At 12:01 pm, Aurobindo Pharma was quoted at Rs 440.20, below Re 1, or 0.23% on the BSE. It touched an intraday high of Rs 445 and an intraday low of Rs 440.10.

In a BSE filing, the company announced that its wholly-owned subsidiary Eugia Pharma Specialties Limited had received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market azacitidine for injection, 100 mg single-dose vials.

Azacitidine for injection, 100 mg single-dose vial, is bioequivalent and therapeutically equivalent to Bristol-Myers Squibb Company’s Reference Listed Drug (RLD) Vidaza for injection, 100 mg single-dose vial. The product is expected to launch this month. Aurobindo Pharma added that, according to IQVIA, the market size for the approved product is estimated to be approximately $46 million for the twelve months ending November 2022.

“This is the 153rd ANDA (including 10 tentative approvals received) for the Eugia Pharma Specialty Group (EPSG) facility, which manufactures oral and sterile speciality products,” the company added.

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