27th June 2017 - 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
Philadelphia, US, and Nottingham, UK, 27th June 2017: QS Pharma, the Contract Development and Manufacturing Organisation (CDMO), which was acquired by Quotient Clinical (“Quotient”) in February 2017, today 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.”
For further information please contact:
Tel: +44 (0)7787 502 947
Marketing Director, Quotient Clinical
Tel: +44 (0)115 931 5102
About QS Pharma www.qspharma.com
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.
About Quotient Clinical www.quotientclinical.com
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.
We employ over 600 staff and operate from state-of-the-art manufacturing and clinical facilities in the UK and USA. We can support our clients, working under FDA or MHRA guidelines, and offer a full range of support services, from study set-up right through to data analysis and reporting.