QS Pharma gets nod from EMA for commercial manufacture
The European Medicines Agency (EMA) has approved QS Pharma to manufacture medicinal products for commercial use in Europe.
At the request of the EMA, the Dutch Health Care Inspectorate (IGZ) inspected QS Pharma’s Boothwyn, PA-based manufacturing facility in February 2017.
The contract development and manufacturing organization (CDMO), previously a Charles River Laboratories business, was acquired by Quotient Clinical the same month for approximately $75m in cash.
According to the company, the inspection focused on two NDA filed products and the company’s overall quality systems.
QS Pharma is now approved to manufacture medicinal products for the US, Europe, and Japan.
