Gland Pharma receives approval for Plerixafor for Injection

Gland Pharma Limited (Gland or Company), a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product).

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

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 USD 152 million for the twelve months ending January 2024.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1706.60 as compared to the previous close of Rs. 1705.15. The total number of shares traded during the day was 25960 in over 2463 trades.

The stock hit an intraday high of Rs. 1763.00 and intraday low of 1674.95. The net turnover during the day was Rs. 44405026.00.

Source : Equity Bulls

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GlandPharma INE068V01023 USFDA Approval PlerixaforInjection