Orchid Pharma, headquartered in Chennai, India, has achieved a significant milestone with the approval of its novel invention, 'Enmetazobactam', by the United States Food and Drug Administration (USFDA). 

This achievement closely follows a recent recommendation for approval by the European Medicines Agency (EMA), positioning Enmetazobactam as the first completely invented-in-India Beta Lactamase Inhibitor.

The USFDA approval sets the stage for the introduction of Enmetazobactam into the United States, the world's largest pharmaceutical market. The product is anticipated to be launched within the next few quarters in the US market.

Under this New Drug Approval (NDA), Exblifep (Cefepime and Enmetazobactam) is authorized for use as an injection in patients aged 18 and above 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.

Orchid Pharma becomes the first Indian company to have invented a product receiving NDA approval from the USFDA, marking a significant step in addressing the global demand for affordable and effective drugs to combat Anti-Microbial Resistance (AMR).

Manish Dhanuka, Managing Director of Orchid Pharma, expressed his thoughts on this milestone, stating, "While the EMA recommendation for marketing authorization last month was a major achievement, the USFDA approval reinforces Orchid's commitment to the safety and necessity of the drug amid rising Antimicrobial resistance."

He further remarked, "First discovered in 2008, it has taken 16 years of painstaking work to bring the product to market. Countless tests were conducted during this time to establish its safety, efficacy, and generate data for submission to regulatory authorities worldwide."

Enmetazobactam, initially developed by Orchid in India and subsequently out-licensed to Allecra Therapeutics for further development, holds the potential to save numerous lives globally.