Aurobindo Pharma Limited announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (FDA) to manufacture and market plerixafor injection, 24 mg/1.2 mL (20 mg/mL), single-dose vial.
The drug is a 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 $ 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).
The Hyderabad-based Aurobindo Pharma has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including US FDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, anti- retroviral, CVS, antibiotics, gastroenterological, anti-diabetics and anti-allergic, supported by a strong R&D set-up.
