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Strides Arcolab, developer of IP-led niche pharmaceutical products, has got USFDA approval for its Agila Specialties’ sterile products manufacturing facility in Bangalore.
According to Mr V.S. Iyer, Executive Director and CEO – Agila Specialties, “Our facility was recently inspected by the USFDA as part of the routine GMP compliance audit and the facility has been classified as acceptable.”
This facility manufactures lyophilised, liquid, dry powder injectables and pre-filled syringes. The last inspection and approval of this site was in March 2009.
The company also announced that it got USFDA approval for fludarabine phosphate injection USP 25 mg/mL, packaged in 50 mg/ 2 mL single-dose vials.
According to IMS statistics, the market for fludarabine in US is about $15 million and it 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 leukemia (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.
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