Strides Arcolab’s sterile products manufacturing facility (SPD 1) in Bangalore has once again been approved by USFDA. The principal sterile facility of Agila, which was recently inspected by the US FDA as part of the routine GMP compliance audit and the facility, has been classified as acceptable. This facility manufactures lyophilized, liquid, dry powder injectables and pre-filled syringes. The last inspection and approval of this site was in March 2009.
USFDA has also accorded its approval for Fludarabine Phosphate Injection USP 25 mg/mL, packaged in 50 mg/2 mL Single-dose vials. According to IMS data, the US market for Fludarabine is approximately USD 15 Million. Fludarabine is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly.
Strides Arcolab is a global pharmaceuticals headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceuticals products with an emphasis on sterlite injectables.
