Gland Pharma Limited, a pharmaceutical company specializing in generic injectables, has obtained approval from the United States Food and Drug Administration (USFDA) for Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial.
In a statement, the company announced that this product is anticipated to be the first generic approval in the market, with plans for imminent launch through its marketing partner. According to IQVIA, the product has recorded US sales of approximately USD 92 million for the twelve months ending in February 2024.
Collaborating with Orbicular Pharmaceutical Technologies Private Limited, Gland Pharma is co-developing various complex injectables, including Eribulin Mesylate Injection.
Established in 1978 in Hyderabad, Gland Pharma has expanded from being a contract manufacturer of small-volume liquid parenteral products to one of the largest injectable-focused companies globally. It operates across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets, primarily under a business-to-business (B2B) model. Renowned for its expertise in developing, manufacturing, and marketing sterile injectables, Gland Pharma offers a diverse range of products, encompassing vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. Additionally, it has played a pioneering role in Heparin technology within India.
