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Month: March 2020

Pharmaceutics International, Inc. (Pii) Expands Aseptic Filling Capabilities with Fully Robotic Filling Line

Pharmaceutics International, Inc. (Pii) Expands Aseptic Filling Capabilities with Fully Robotic Filling Line

Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), announces the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line. ...  Read more

Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic

Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic

Germantown, MD, USA (March 30, 2020) – On March 27, Amarex executed a rush submission to the US FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result. ...  Read more