Gland Pharma's Zoledronic Acid Injection Gets USFDA Approval

Gland Pharma has received USFDA approval for its Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL), in single-dose bags, marking a significant milestone in the company's growth.

 It was given the green light on its shortened abbreviated new drug application (ANDA), to confirm that the product is bioequivalent and therapeutically equivalent with respect to the reference listed drug (RLD), Zoledronic Acid Injection, produced by InfoRLife.

This acceptance opens the door to Zoledronic Acid Injection of Gland Pharma to cure hypercalcemia of malignancy, multiple myeloma, and bone metastases of solid tumors. The product will be able to address the needs of patients who are undergoing treatment against these conditions since it has proven bioequivalence with the RLD.

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IQVIA data shows that the US market segment of this drug has a high potential in the market and it is projected to make about 6.7 million dollars in sales over the twelve months until November 2025.

Founded in 1978 in Hyderabad, Gland Pharma has grown to become one of the largest injectable based companies in the world that started as a contract manufacturer of small-volume liquid parenteral products. It is currently working in 60 countries and in some of the key markets such as the United States, Europe, Canada and India, which strengthens its status as a fast growing player in the pharmaceutical industry.