Strides Arcolab announced the following US FDA approvals for Sterile Products manufacturing facility (SPD 1) in Bangalore and fludarabine phosphate injection USP 25 mg/mL, packaged in 50 mg/ 2 mL Single-dose vials for Onco Therapies Limited (a wholly owned subsidiary of Strides).
The SPD 1, principal sterile facility of Agila 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.
V S Iyer, executive director and CEO, Agila said, “This approval endorses our commitment to continued compliance with cGMP.”
According to IMS data, the US market for fludarabine is approximately US$ 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.
Fludarabine injection is used to treat chronic lymphocytic leukaemia (CLL; a type of cancer of the white blood cells) in adults who have already been treated with at least one other medication and have not gotten better.
Agila Specialties Private Limited is the specialties unit of Strides Arcolab focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars.
Strides Arcolab, a global pharmaceutical company that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.