QS Pharma receives EMA approval for medicinal products manufacturing
US-based pharmaceutical company QS Pharma has received approval from the European Medicines Agency (EMA) to produce certain medicinal products for commercial use in Europe.
The Contract Development and Manufacturing Organisation (CDMO), QS Pharma, was purchased by UK-based early phase drug development services provider Quotient Clinical in February this year.
QS Pharma managing director Nutan Gangrade said: “QS Pharma is dedicated to maintaining a robust quality system, underpinned by our excellent regulatory history.
“This approval by the EMA ensures we are able to support customers with interests in Europe, creating further growth opportunities for the business.”
The approval was granted after the company’s manufacturing facility in Boothwyn, Pennsylvania, US, was inspected in February by the Dutch Health Care Inspectorate (IGZ) at the request of the EMA.
The inspection focused on two new drug application (NDA)-filed products and the overall quality systems of QS Pharma.
Following the successful outcome of the inspection, in addition to the past approvals received from the US Food and Drug Administration (FDA) and the Prescription Drug Marketing Act (PDMA), the company has currently been granted permission to manufacture medicinal products for the US, Europe and Japan.
Quotient Clinical chief executive officer Mark Egerton said: “QS Pharma is becoming a major global player in the commercial manufacture of market products, with a focus on high-potency manufacturing, and niche therapies and markets such as orphan drugs, for tablets, capsules and oral liquids. This latest inspection and approval adds further value to the business.”