Gland Pharma Gets USFDA Nod for Zoledronic Acid Injection for Cancer-Related Bone Disorders
Hyderabad: Gland Pharma Limited, a generic injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) single-dose bags.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL), marketed by Info RLife. The injection is indicated for the treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases arising from solid tumors.
According to IQVIA data, Zoledronic Acid Injection recorded sales of approximately USD 6.7 million in the United States for the twelve-month period ending November 2025, indicating a modest but stable market opportunity for the product.
With this approval, Gland Pharma continues to strengthen its injectable portfolio in the US market, reinforcing its focus on complex sterile injectables and oncology-related therapies.
Established in 1978 and headquartered in Hyderabad, Gland Pharma operates primarily under a business-to-business (B2B) model and has built a strong global presence across over 60 countries, including the United States, Europe, Canada, Australia, and India. The company has a proven track record in developing and manufacturing sterile injectables across multiple dosage forms such as vials, ampoules, pre-filled syringes, lyophilized products, infusions, oncology injectables, and ophthalmic solutions. It is also recognised for pioneering heparin technology in India.
