Gland Pharma Receives USFDA Approval for Zoledronic Acid Injection
Gland Pharma received USFDA approval for Zoledronic Acid Injection, 4 mg/100 mL Single-Dose Bags. The product is a generic alternative to InfoRLife's Zoledronic Acid Injection. The US market for this product was approximately USD 6.7 million for the twelve months ending November 2025.
The approval of a new drug product, while positive, is for a specific indication and a market size of USD 6.7 million, which is not substantial enough to have a very high impact on the overall financials of a large company like Gland Pharma. However, it contributes to the company's product portfolio and revenue stream.
The USFDA approval for a new drug product is a positive development for the company, indicating successful product development and regulatory compliance, which is expected to contribute to revenue growth.
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.
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