Eugia Pharma receives USFDA approval for Plerixafor Injection
Drug Approval

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023

  • By IPP Bureau | July 26, 2023

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).

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