RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP announced recently that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of the FDA’s rolling review process supporting the New Drug Application for ZYESAMI.
NRx also announced it has received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. NRx awaits a QP Declaration that is required by the EU regulatory authorities for the release of ZYESAMI. The audit was completed in preparation for submission of European Union (EU)-standard ZYESAMI to EU and United Kingdom health regulatory authorities. Under EU law, a QP Auditor is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU or imported into the EU.
“As thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval,” said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.
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