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Protalix Wins FDA Approval as Multi-Product Facility

To support the potential manufacture of pegunigalsidase alfa and taliglucerase alfa on a commercial scale

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By: Kristin Brooks

Managing Editor, Contract Pharma

Protalix BioTherapeutics received approval from the FDA for a Supplemental New Drug Application (sNDA) allowing the company to convert its manufacturing facility in Carmiel, Israel, from a single dedicated product facility to a multi-product facility. The conversion of the facility will serve the company’s production needs for the anticipated commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease together with the current and expected increase in the manufactur...

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