MHRA Approval for Quay GMP Manufacturing Suites

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MHRA Approval for Quay GMP Manufacturing Suites

Quay Pharma GMP SuitePharmaceutical outsourcing specialist Quay Pharma has received full MHRA approval for its newly installed GMP manufacturing suites at its headquarters in Deeside, UK.

The new suites are part of a £3 million investment, which has increased the company’s overall manufacturing capacity and enabled it to make larger batches of product to continue support through Phase III clinical trials and small-scale commercial manufacture for all non-sterile products.

The GMP facility will also support a number of Quay Pharma’s specialist areas where the company is experiencing increasing demand.  These include the development of orphan drugs and potent products. In addition, one room is equipped to allow the manufacture of products at very low humidity to meet another growing customer requirement for new innovative formulations.

“The establishment of the GMP suites is the next logical step in our continued expansion and will further enhance the level of service and support that we can offer our clients,” comments Quay Pharma CEO Maireadh Pedersen.

Established in 2002 by Professor Mike Rubinstein, Quay Pharma’s range of services includes early stage (preclinical) formulation development, novel drug delivery design, analytical R&D development, stability testing, and clinical trial manufacture, commercial manufacture and packing of new drug compounds.

The company offers particular expertise in oral dosage form design and semi solids formulation and development, in particular new drugs that exhibit poor solubility and bioavailability. Clients include both small and large pharmaceutical and biotechnology companies worldwide, with recent successes in a diverse number of territories including France, Germany, Switzerland, Israel and Japan.