Orchid Pharma stock surged over 6 per cent on the NSE on Friday, following the receipt of approval for its Enmetazobactam injection, a Beta-Lactamase Inhibitor invented in the country.
The company based in Chennai has received the United States Food and Drug Administration (USFDA) approval for its Exblifep, it said in a stock exchange filing and added that the development comes in close succession to the recent recommendation for approval by the European Medicines Agency (EMA).
The product is expected to be launched in the US market within a couple of quarters.
The New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.
Manish Dhanuka, Managing Director at Orchid Pharma, said, “While the EMA recommendation for the grant of marketing authorization last month was a big achievement, the USFDA approval reinforces Orchid’s position on the safety of the drug and its innate need in the times of increasing Antimicrobial resistance.”
The stock surged by 6.64 per cent to close at ₹1,225 on Friday.