Gland Pharma Gets USFDA Approval for Zoledronic Acid Injection Used in Cancer Treatment

Gland Pharma Limited has received approval from the US Food and Drug Administration (USFDA) for its Zoledronic Acid Injection, 4 mg/100 mL single-dose bags.
The drug is bioequivalent and therapeutically equivalent to the reference product listed in the US market.

Medical Use of the Drug

Zoledronic Acid Injection is used to treat hypercalcemia caused by cancer, as well as multiple myeloma and bone metastases from solid tumors.
These conditions are commonly linked with advanced stages of cancer and require effective supportive treatment.

Market Opportunity

According to industry data, the approved product generated around $6.7 million in US sales during the twelve months ending November 2025, indicating a moderate but stable market opportunity.

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About Gland Pharma

Founded in 1978 in Hyderabad, Gland Pharma has grown from a small contract manufacturer into a major global injectable-focused pharmaceutical company.
The company operates mainly on a business-to-business model and has a presence in more than 60 countries, including the United States, Europe, Canada, Australia, and India.

Conclusion

The USFDA approval for Zoledronic Acid Injection strengthens Gland Pharma’s oncology and injectable portfolio in the US market. This development supports the company’s steady global expansion and long-term growth strategy.

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