Protalix Biotherapeutics, Inc. Announces Successful Manufacturing Facility Evaluation By Health Canada
Published: Jan 24, 2014
CARMIEL, Israel, Jan. 23, 2014 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that Health Canada has completed a successful on-site evaluation of the Company's manufacturing facility in Carmiel, Israel, as part of its ongoing review of the new drug submission (NDS) for taliglucerase alfa for the treatment of Gaucher disease. The purpose of the on-site evaluation was to verify the facility's compliance with certain Canadian food and drug regulations and, upon completion of the evaluation, Health Canada recommended approval from a facility perspective. A decision on final marketing approval of taliglucerase alfa in Canada is expected during 2014.
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