Drug firm Strides Arcolab today said the company has received approval from the US health regulator for its Bangalore-based manufacturing plant.
Besides, the company has received approval from the US food and Drug Administration (USFDA) for marketing fludarabine phosphate injection, used for treating cancer, in the American market, Strides Arcolab said in a filing to the Bombay Stock Exchange (BSE).
"The sterile products manufacturing facility in Bangalore, the principal facility of Agila, which was recently inspected by the USFDA as part of the routine GMP compliance audit and the facility has been classified as acceptable," it added.
The facility produces lyophilised, liquid, dry powder injectables and pre-filled syringes, it said.
Besides, the company's subsidiary Onco Therapies Ltd has received USFDA approval for fludarabine phosphate injection in strengths of 25 mg/ml, packaged in 50 mg/2 ml single dose vials, it added.
According to IMS data, the US market for fludarabine is nearly $15 million. It is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly, it said.
Shares of Strides Arcolab today closed at Rs 391 on the BSE, up 3% from previous close.
