Gland Pharma receives USFDA approval for Eribulin Mesylate injection

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

Gland Pharma Limited, a generic injectable-focused pharmaceutical 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 said in a statement.

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

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and has an excellent track record in the development, manufacturing, and marketing of sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions, and also enjoys the distinction of having pioneered Heparin technology in India.