Gland Pharma Gains USFDA Nod for Zoledronic Acid Injection

Gland Pharma Limited has received approval from the United States Food and Drug Administration (USFDA) for its Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) Single-Dose Bags. This approval pertains to the company’s Abbreviated New Drug Application. The product is bioequivalent and therapeutically equivalent to the reference listed drug, Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) by InfoRLife. The product is indicated for the treatment of Hypercalcemia of Malignancy, Multiple Myeloma, and Bone Metastases of Solid Tumors.

According to IQVIA, the Zoledronic Acid Injection had US sales of approximately USD 7 million for the twelve months ending November 2025. This financial data highlights the market presence of the product in the United States. The approval from the USFDA allows Gland Pharma to market this product in the US, potentially expanding its market share in the injectable pharmaceutical segment.

The Zoledronic Acid Injection is designed as a single-dose bag with a concentration of 4 mg/100 mL (0.04 mg/mL). It is used in the medical management of conditions such as Hypercalcemia of Malignancy and Multiple Myeloma. The product’s bioequivalence to the reference listed drug ensures its therapeutic efficacy and safety for patients. This approval is part of Gland Pharma’s strategy to enhance its portfolio of generic injectables.

Gland Pharma, established in 1978, has evolved from a contract manufacturer of small-volume liquid parenteral products to a significant player in the injectable pharmaceutical industry. The company operates in over 60 countries, including the United States, Europe, Canada, Australia, and India. It follows a business-to-business (B2B) model and has a comprehensive range of sterile injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

The approval from the USFDA is effective immediately, allowing Gland Pharma to commence distribution and marketing of the Zoledronic Acid Injection in the United States. The company will manage the production and supply chain to ensure the availability of the product in the US market. The approval process was conducted in compliance with the regulatory requirements set by the USFDA, ensuring adherence to quality and safety standards.

Gland Pharma Limited focuses on developing, manufacturing, and marketing sterile injectables. The company has a strong track record in the pharmaceutical industry and has pioneered Heparin technology in India. Gland Pharma continues to expand its global footprint and enhance its product offerings in the injectable segment.