Nasal spray manufacturer Summit Biosciences gets GMP certificate from MHRA

Summit Biosciences has announced that it can now produce prescription nasal sprays for the the European market after receiving EU GMP certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its manufacturing facilities in Lexington, Kentucky.

According to the company, Summit sought the certification “in anticipation of the European launch of a prefilled, single-dose, intranasal product for an undisclosed international client.”

Summit Biosciences Chief Operating Officer Greg Plucinski commented, “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.”

In 2014, Summit announced that it had successfully completed an FDA pre-approval inspection of the facility in preparation for production of a nasal spray product.

Read the Summit Biosciences press release.