Gland Pharma receives USFDA nod for Zoledronic Acid Injection
Gland Pharma announced that it 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.
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), manufactured by InfoRLife.Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases of solid tumors.
According to IQVIA data, the product recorded US sales of approximately $6.7 million during the twelve months ended November 2025.
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 and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.
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