PolyPid Ltd. announced on September 16, 2025, the successful completion of a routine Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health. This marks the fourth consecutive successful GMP inspection of PolyPid's manufacturing facility.
The Israeli Ministry of Health operates under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework, which means European regulatory authorities rely on these inspections for EU GMP compliance certification. This confirms the facility's readiness for commercial production in the European market.
This milestone is crucial as PolyPid advances toward its planned New Drug Application (NDA) submission for D-PLEX100 in early 2026. The successful inspection serves as preparation for the subsequent U.S. Food and Drug Administration (FDA) facility inspection, reinforcing the company's path to commercialization in both U.S. and European markets.
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