Gland Pharma Limited 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) in single-dose bags, marking another regulatory milestone for the company’s US generics portfolio.
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) of InfoRLife. Zoledronic Acid Injection is widely used in oncology care and is indicated for the treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases arising from solid tumors. These indications make the product clinically significant in managing skeletal-related complications in cancer patients.
This USFDA approval strengthens Gland Pharma’s presence in the high-value injectable generics segment, where regulatory entry barriers are relatively high and competition is limited compared to oral solids. The product will be marketed in a ready-to-use single-dose bag format, a presentation that is often preferred in hospital settings due to ease of administration and reduced preparation time.
According to IQVIA, Zoledronic Acid Injection recorded US sales of approximately USD 6.7 million for the twelve months ended November 2025. While the market size is modest, such niche injectable products typically offer stable demand and attractive margins, supporting long-term revenue visibility for manufacturers with strong compliance capabilities.
