NTC and Aspen announce SAHPRA positive outcome for the fixed dose combination of levofloxacin and dexamethasone multidose eye drops

MILAN, Nov. 24, 2021 /PRNewswire/ — NTC Srl, R&D driven pharmaceutical company with headquarters in Italy, and Aspen Pharmacare Holdings Limited (“Aspen”), a South African-headquartered global specialty and branded pharmaceutical company, announced today that the South Africa Health Products Regulatory Authority (“SAHPRA”) has approved the first fixed combination of an ophthalmic quinolone antibiotic (levofloxacin) with an anti-inflammatory steroid (dexamethasone) eye drops solution indicated for the prevention and treatment of inflammation, and the prevention of infection associated with cataract surgery in adults. 

NTC granted the license and commercialization rights of its patented research and development product to Aspen for South Africa and other African countries and has provided full technical and regulatory support to Aspen which has secured market authorization for the product in South Africa. 

“We are proud of this strategic partnership with a leading company such as Aspen,” Riccardo Carbucicchio, President and CEO of NTC, states. “We are excited to have achieved a regulatory approval in half the time compared to standard timeframes. We trust that many patients undergoing cataract surgery will benefit from our innovation in South Africa,” he adds. 

Richelle Crots, Aspen Pharmacare Regional CEO, SA Commercial, said, “Aspen is pleased to enter into a South African partnership with NTC to commercialize this novel combination for the prevention and treatment of eye inflammation and the prevention of infection associated with cataract surgery in adults. This partnerships bolsters Aspen’s vision of providing high quality, affordable products to patients. We are excited to have been offered the opportunity to launch this innovative product in the local ophthalmology market segment.” 

This novel NTC fixed combination product has now been partnered and out-licensed by NTC across nearly 80 countries around the world. 

About NTC 

NTC is a pharmaceutical company headquartered in Milan – Italy, with distributors and partners in over 100 countries in the world, engaged in research, development, registration and commercialization of drugs, medical devices, and food supplements in ophthalmology, but also in other therapeutic areas like gastro-metabolism, gynecology and pediatrics. NTC offers to its partners, currently nearly 250 companies, innovative pharmaceutical products with high quality standards. For more information, please visit www.ntcpharma.com. 

About Aspen 

Headquartered in Durban, South Africa, Aspen is a partner of choice as it is a global specialty and branded multinational pharmaceutical company, with a presence in both emerging and developed markets. Aspen improves the health of patients in more than 150 countries through its high quality, affordable medicines. Active at every stage of the value chain, Aspen is uniquely diversified by geography, product and manufacturing capability. The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. For more information, please visit https://www.aspenpharma.com. 


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