Rockwell Medical, Inc., a healthcare company, announced that its international partner, Drogsan Pharmaceuticals, submitted a Marketing Authorization application and GMP application for Triferic AVNU to the Turkish Medicines and Medical Devices Agency (TMMDA), for which Drogsan received priority status and high priority status, respectively.
Triferic AVNU (ferric pyrophosphate citrate injection) is an iron replacement product indicated to maintain haemoglobin in adult patients undergoing haemodialysis. In June 2021, Rockwell entered into license and supply agreements with Drogsan, one of the leading pharmaceutical companies in Turkey, for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms of the agreements, Drogsan will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, Rockwell received an upfront payment and will be eligible for milestone payment and royalties on net sales. Drogsan will be responsible for all regulatory approval and commercialization activities, and the company will supply the product to Drogsan for Turkey.
"Rockwell
