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Summit Biosciences announces successful preapproval inspection for nasal spray

Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is for a new nasal spray. In early 2011, Summit announced that it had received a federal grant for development of a synthetic THC nasal spray.

Summit COO Greg Plucinski commented, “Our team’s expertise, drive and focus on quality have enabled us to secure top tier clients and partners that have put their trust in us to manufacture their products. This trust and our performance have now been validated by a successful FDA inspection. We are extremely pleased with the results of this inspection and believe it is a direct reflection of our high caliber team and their commitment to quality in all areas of our operations.”

According to the UK College of Pharmacy website, the company has raised $2 million for development of the synthetic THC nasal spray for the treatment of nausea and vomiting in patients receiving chemotherapy for cancer.

Read the Summit Biosciences press release.

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published on March 31, 2014

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