Receives US FDA approval for Cisplatin injection
Strides Arcolab announced that Agila Specialities (a wholly-owned subsidiary of Strides) has acquired a US FDA approved sterile formulations facility situated at Hosur, Tamil Nadu from Star Drugs and Research Labs. The facility manufactures a wide range of injectable formats. The liquid vials unit with a capacity of 97 million units has recently been approved by the US FDA. The facility in Hosur is in close proximity to the Strides new sterile complex, in the outskirts of Bangalore. Strides expects to ship products to the US from this facility from third quarter of 2012.
The consideration for the facility is approximately Rs 1250 million and is being funded from cash in hand and internal accruals. Commenting on the development, Arun Kumar, Group Chief Executive officer, Strides Arcolab said, “This timely acquisition brings into our fold, an asset which is of immediate importance given the demand for Sterile injectables worldwide.”
Apart from this, Onco Therapies, a wholly-owned subsidiary of Strides Arcolab has received US FDA approvals for Cisplatin Injection, 1 mg/mL packages in 50 mL and 100 mL multiple dose vials. Cisplatin is among the products in the drug shortage list of US FDA. According to IMS data, the US market for generic Cisplatin is approximately $10 million.
Cisplatin is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly.
EP News Bureau — Mumbai