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PolyPid has received Certificate of GMP Compliance of a manufacturer

July 7, 2018 at 8:00 AM EDT
During July 2018, PolyPid has received Certificate of Good Manufacturing Practice (GMP) Compliance of a manufacturer. Manufacturer’s / Importer’s Authorization (MIA)  was issued following an inspections in accordance with the requirements of GMP, of the Israeli laws and regulations, and issued under the provision of the Conformity Assessment and Acceptance of Industrial Products (CAA) Agreement between the European Union and Israel . The Certificate applies to D-PLEX investigation medicinal product under phase III clinical study stage.

Technology

PolyPid’s PLEX targeted drug delivery platform enables localized, controlled, continuous release of medication over prolonged periods of time for better patient outcomes.

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D-PLEX100

D-PLEX100

Provides safe and effective local antibiotic protection against SSI (surgical Site Infection) at the needed tissues or organs by administration during surgical procedures.

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D-PLEX1000

D-PLEX1000

Comprised of antibiotic eluting ß tri-calcium phosphate (ßTCP) granules, designed for bone related infections applications.

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