QS Pharma Receives Approval From European Medicines Agency For Commercial Manufacture

QS Pharma, a Quotient Clinical business, is now approved to manufacture medicinal products for the US, Europe and Japan

QS Pharma, the Contract Development and Manufacturing Organisation (CDMO), which was acquired by Quotient Clinical (“Quotient”) in February 2017, recently announced it has received approval from the European Medicines Agency (EMA) to manufacture certain medicinal products for commercial use in Europe.

QS Pharma’s manufacturing facility in Boothwyn, Pennsylvania, was inspected in February 2017 by the Dutch Health Care Inspectorate (IGZ) at the request of the EMA. The assessment focused on two NDA filed products, and the overall quality systems of QS Pharma. Following the successful outcome of the inspection, added to past approvals from the FDA and PDMA, QS Pharma is now approved to manufacture medicinal products for the US, Europe and Japan.

Nutan Gangrade, Managing Director, QS Pharma, 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.”

Mark Egerton, Chief Executive Officer, Quotient Clinical, 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.”

About QS Pharma
Founded in 2002, QS Pharma specialises in the formulation development and manufacturing of small molecule drug products, and is capable of supporting customer programs through all stages of development and commercialisation. Of particular relevance is QS Pharma’s capability to work with high potency molecules, which is a fast-growing market need. QS Pharma was acquired by Quotient Clinical in February 2017. Further details of the announcement can be viewed here (http://www.quotientclinical.com/quotient-clinical-announces-second-us-acquisition-qs-pharma/). For more information, visit http://www.qspharma.com.

About Quotient Clinical
Quotient Clinical is a drug development services provider, focused on helping clients reduce the time and cost of bringing a drug to market. We deliver integrated capabilities including formulation development, GMP drug product manufacturing and clinical pharmacology services to biotech and pharmaceutical clients globally. For more information, visit http://www.quotientclinical.com.