The Nuceiva Manufacturing Facility acquires GMP Approval from Health Canada

The Nuceiva Manufacturing Facility acquires GMP Approval from Health Canada - Passed audit by Health Canada conducted from May 14-18 Daewoong Pharmaceutical (CEO Sengho Jeon) announced that the Nuceiva manufacturing facility acquired GMP approval from Health Canada on May 18, after acquiring US FDA cGMP approval on May 15. For this approval for Daewoong Pharmaceutical’s botulinum toxin, Nuceiva, Daewoong Pharmaceutical was under an audit from May 14 to 18. The result came out on the 18th with a C, for compliant. Last July, Daewoong Pharmaceutical filed NDS(New Drug Submission) to Health Canada, which was accepted in October. Canada’s GMP approval is a must-have for sales permit in Canada. With the approval, it was confirmed that the Nuceiva manufacturing facility complies with Canadian pharmaceutical products manufacturing regulations and that Daewoong Pharmaceutical safely and methodically produces and manages pharmaceutical products. Canada is a member of G7 and an advanced nation in terms of pharmaceuticals as it was the 5th member of ICH, after US, EU, Japan and Switzerland. Seongsu Park, head of Nabota Business HQ, said, “For a successful global business for Daewoong's botulinum toxin product, we methodically prepared for GMP approval for each major country. We finally acquired approval in Canada after the US.” With Canadian GMP approval for the manufacturing facility, Daewoong Pharmaceutical expected final approval within this year, given the remaining procedure goes unhindered. #   #   # [Photo] Daewoong’s Manufacturing Facility for its botulinum toxin product

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