|
This New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.
This USFDA approval paves the way for the introduction of Enmetazobactam in the United States, the largest pharmaceutical market in the world. The product is expected to be launched within the next couple of quarters in the US market.
Manish Dhanuka, managing director, Orchid Pharma, said, “While EMA recommendation for 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.”
Orchid Pharma is one of the leading pharmaceutical companies in India head quartered in Chennai and involved in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals with exports spanning over 40 countries.
The pharmaceutical company reported consolidated net profit of Rs 29.43 crore in Q3 FY24, steeply higher than Rs 7.59 crore posted in Q3 FY23. Revenue from operations increased 38.07% YoY to Rs 220.59 crore in the quarter ended 31 December 2023.
Orchid Pharma rose 5.76% to end at Rs 1,217.20 on the BSE.
|