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NerPharMa Approved to Manufacture CTI Drug

The FDA has completed its inspection of Cell Therapeutics, Inc.’s (CTI) facility at NerPharMa, a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences in Nerviano, Italy.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has completed its inspection of Cell Therapeutics, Inc.’s (CTI) facility at NerPharMa, a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences in Nerviano, Italy. FDA found the site in compliance for continued manufacture of CTI’s pixantrone product. CTI’s NDA for pixantrone is currently under review to treat relapsed/refractory aggressive non-Hodgkin’s lymphoma. The FDA is expected to make a final decision on approval by April 23rd. “FDA approval of the Ne...

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