Gland Pharma Limited, a manufacturer specializing in injectable and ophthalmic pharmaceuticals, has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Zoledronic Acid Injection, 4 mg/100 mL (0.04mg/mL) in single-dose bags. The approved product has been deemed bioequivalent and therapeutically equivalent to the reference listed drug, Zoledronic Acid Injection, 4 mg/100 mL, marketed by InfoRLife.
Zoledronic Acid Injection is used in the treatment of hypercalcemia associated with malignancy, multiple myeloma, and bone metastases from solid tumors. Based on IQVIA data, the product generated approximately USD 6.7 million in US sales during the twelve-month period ending November 2025.
Gland Pharma Limited is a leading Indian pharmaceutical company specializing in injectable formulations and ophthalmic products, with a strong focus on complex generics. Headquartered in Hyderabad, the company has built a reputation for its capabilities in sterile injectables, which are among the most technically demanding segments of the pharmaceutical industry.
Gland Pharma serves regulated and semi-regulated markets, with the United States being its largest market. A significant portion of its revenue comes from supplying generic injectables to global pharmaceutical companies through long-term partnerships, as well as through its own product filings.
The company’s portfolio spans therapeutic areas such as oncology, anti-infectives, cardiovascular, central nervous system, and pain management. The company operates multiple manufacturing facilities in India, most of which are approved by major global regulatory authorities including the US Food and Drug Administration (USFDA).
Its emphasis on compliance, quality systems, and process automation has helped it maintain consistent regulatory standards. Innovation and cost-efficient manufacturing are central to Gland Pharma’s strategy. By focusing on complex molecules, difficult-to-manufacture dosage forms, and limited-competition products, the company aims to strengthen margins and reduce commoditization risks. With a growing pipeline of injectable products and expanding global reach, Gland Pharma continues to position itself as a key player in the global generic injectables market.
