Gland Pharma receives US FDA nod for immunostimulant Plerixafor

The generic injectable-focused pharmaceutical company said that it has has received approval from the United States Food and Drug Administration (US FDA) for Plerixafor Injection.

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a Sanofi Company.

Gland Pharma stated that the product is a hematopoietic stem cell mobilizer indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.

The company expects to launch this product through its marketing partner within FY25.

According to IQVIA, the product had US sales of approximately $152 million for the twelve months ending January 2024.

Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.

The companys consolidated net profit fell 17.28% to Rs 191.86 crore in Q3 FY24 as against with Rs 231.95 crore posted in Q3 FY23. Revenue from operations jumped 64.68% to Rs 1,545.2 crore in Q3 FY24 as against Rs 938.29 crore recorded in Q3 FY23.

The scrip shed 0.33% to currently trade at Rs 1699.50 on the BSE.

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