The inspection was done in connection with the Brazilian Ministry of Health’s investigation of the new drug application (NDA) filed with ANVISA for taliglucerase alfa to treat gaucher disease.
Additionally, the US Food and Drug Administration (FDA) and the Israeli Ministry of Health have also approved the manufacturing facility as it adhere GMP compliance.
Protalix president and CEO David Aviezer said the successful audit of the manufacturing facility by Brazil’s ANVISA is an important milestone.
"This important achievement helps demonstrate the viability, quality and commercial potential of our proprietary, plant-cell based technology platform," Aviezer said.