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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment of complicated urinary tract infections (cUTI). The new drug EXBLIFEP is a combination drug of Enmetazobactam with Cefixime, a cephalosporin antibacterial. Exblifep is an injection product administered every 8 hours by intravenous infusion over 2 hours for 7 days to 14 days. In a press release to the stock exchanges Orchid Pharma stated the approval as a new milestone for India’s pharmaceutical Industry. Orchid is the first Indian company to have invented a product approved under the New Drug Application (NDA) process by USFDA. In Europe Exblifep had received recommendation for granting approval (Marketing authorisation) in Jan 2024 from Committee for Medicinal Products for Human Use (CHMP) and European Medicines Agency (EMA). Enmetazobactam is the first completely invented-in-India Beta Lactamase Inhibitor. Enmetazobactam was invented in India by Orchid and licensed to Allecra Therapeutics for further development.
Image Courtesy: NCBI
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