Summit Biosciences Receives EU Approval for Commercial Manufacturing of Prescription Nasal Sprays
LEXINGTON, Ky., Sept. 14, 2017 Summit Biosciences Inc. is pleased to announce that it has received a certificate of GMP compliance from the Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of the European Medicines Agency (EMA) after a successful inspection of the company's manufacturing facilities in Kentucky. Certification will permit Summit to produce prescription nasal spray products for export to its customers in Europe.
This regulatory milestone marks another important step forward in Summit's rapid growth in a unique segment of the global pharmaceutical industry. Combination products are difficult to make and require competencies across a range of technical disciplines. Summit has achieved this level of manufacturing excellence in anticipation of the European launch of a prefilled, single-dose, intranasal product for an undisclosed international client.
"I applaud our entire team for their dedication to regulatory excellence and this outstanding achievement," said Edwin Cohen, Summit's Founder and Chief Executive Officer. "The company's unwavering commitment to Current Good Manufacturing Practices (cGMP) provides confidence to customers, doctors, and their patients that our products are manufactured under strict adherence to the highest level of quality standards no matter where they are sold," said Greg Plucinski, Summit's Chief Operating Officer.
Summit Biosciences Inc. is a privately-held pharmaceutical company that develops, manufactures and commercializes prescription and OTC sublingual and nasal spray products. The company has approved and development-stage products across a range of indications. The company's headquarters and base of operations are on the Coldstream Research Campus of the University of Kentucky.