Eugia Pharma receives USFDA Approval for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial

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 Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mozobil Injection, 24 mg/1.2 mL (20 mg/mL) of Genzyme Corporation. The product is being launched in July FY24. The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023, according to IQVIA.

This is the 163rd ANDA (including 8 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 785.15 as compared to the previous close of Rs. 779.40. The total number of shares traded during the day was 43980 in over 1760 trades.

The stock hit an intraday high of Rs. 791.85 and intraday low of 770.80. The net turnover during the day was Rs. 34513488.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 EugiaPharmaSpecialities FinalApproval USFDA PlerixaforInjection