Gland Pharma Limited (Gland or Company) has received approval from the United States Food and Drug Administration (USFDA) for Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial (Product). The Product is expected to be the first generic approval on the market, and the Company expects to launch this product in the near term through its marketing partner. The Product has US sales of approximately USD 92 million for twelve months ending in February 2024, according to IQVIA.

The Company is co-developing several complex injectables, including this Product, with Orbicular Pharmaceutical Technologies Private Limited.