Agila receives FDA approval for Zoledronic Acid

According to IMS data, the US market for Zoledronic Acid 5ml is about $520 million


Agila Specialties, a wholly owned subsidiary of Strides Arcolab (Strides) received ANDA approval for Zoledronic Acid Injection 4 mg (base)/5 ml, packaged in single dose vials. According to IMS data, the US market for Zoledronic Acid 5ml approximately $520 million. The product is expected to be launched shortly.

Zoledronic Acid is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones.

Agila, Specialties business of Strides Arcolab is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from nine world-class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila's marketing network covers 70 countries and it has partnerships with some of the world's leading pharmaceutical companies for both developed and emerging markets.

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