PHILADELPHIA & NOTTINGHAM, England--(BUSINESS WIRE)--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.”
ENDS
About QS Pharma http://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 http://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.
