Summit Biosciences said today that it won a certificate of GMP compliance from the Medicines and Healthcare Products Regulatory Agency on behalf of the European Medicines Agency.
The decision comes after a successful inspection of the company’s manufacturing plant in Kentucky.
The certificate allows Summit to produce prescription nasal spray products to be exported to its customers in Europe. The company said that the move is in anticipation of the European launch of a prefilled, single-dose, intranasal product from an undisclosed international client.
“I applaud our entire team for their dedication to regulatory excellence and this outstanding achievement,” founder & CEO Edwin Cohen said in prepared remarks.
“The company’s unwavering commitment to Current Good Manufacturing Practices 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,” COO Greg Plucinski added.
The privately-held pharmaceutical company, based on the Coldstream Research Campus at the University of Kentucky, develops, manufactures and commercializes prescription and over-the-counter sublingual and nasal spray products.
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