Gland Pharma Limited has 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) 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) of InfoRLife. This injection is indicated for the treatment of Hypercalcemia of Malignancy and Multiple Myeloma and Bone Metastases of Solid Tumors. According to IQVIA data, the product had US sales of approximately USD 6.7 million (₹55.6 crore) for the twelve months ending November 2025. Gland Pharma, established in 1978, is a generic injectable and ophthalmic-focused pharmaceutical company with a global presence in over 60 countries. The company operates primarily on a business-to-business (B2B) model and has a strong track record in developing, manufacturing, and marketing sterile injectables.
