USFDA grants QIDP Designation to Venus Remedies’ investigational product VRP-034

United States Food and Drug Administration (USFDA) has granted Qualified Infectious Disease Product (QIDP) Designation to Venus Remedies’ investigational product VRP-034, for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults. 

Developed by Venus Medicine Research Centre (VMRC), the R&D division of Venus Remedies, VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed to address the nephrotoxic effects associated with conventional polymyxin B therapy. The QIDP designation, granted under the Generating Antibiotic Incentives Now (GAIN) Act. provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast-track designation, and an additional five years of market exclusivity upon approval in the United States. This recognition by USFDA strengthens Venus Remedies’ commitment to innovation in the fight against AMR and underlines the company’s dedication to addressing unmet needs in infectious disease therapy. 

Venus Remedies is one of the handful player in pharmaceutical sector to launch world global injectable manufacturers.