Agila Specialties Pvt. Ltd., a wholly owned subsidiary of Strides Arcolab Limited has 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 is estimated at approximately US$ 520 million.
Zoledronic Acid is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. It 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
On February 28, 2013, Strides Arcolab entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties Private Limited and its overseas specialties subsidiary, Agila Specialties Asia Pte. Limited, Singapore to Mylan Inc., for US$ 1.6 billion. The deal will be through in around six months as it is dependent on the FIPB (Foreign Investment Promotion Board) approval.
Agila Specialties’ business 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 the country and and amongst the largest lyophilization (freeze drying) capacities in the world. Its marketing network spans 70 countries and it has partnerships with leading global pharmaceutical companies for both developed and emerging markets.