"The first Indian-discovered antibiotic has received FDA approval after a 16-year journey to reach the market."

Indian Origin Antibiotic:Enmetazobactam

"Orchid Pharma, headquartered in Chennai, India, has gained approval from the United States Food and Drug Administration (USFDA) for its innovative creation, 'Enmetazobactam.' This milestone closely follows the recent recommendation for approval by the European Medicines Agency (EMA). Enmetazobactam marks the debut of India's first entirely developed Beta Lactamase Inhibitor."

"The USFDA approval opens doors for the introduction of Enmetazobactam into the United States, the world's largest pharmaceutical market. The product is anticipated to debut in the US market within the next few quarters."

"The New Drug Approval (NDA) now allows for the use of Exblifep (Cefepime and Enmetazobactam) as an injectable treatment for 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.

Orchid Pharma marks a historic milestone as the first Indian company to invent a product granted NDA approval by the USFDA. This achievement is a significant step forward in addressing the global demand for affordable and effective drugs to combat Antimicrobial Resistance (AMR)."

"In light of this milestone, Mr. Manish Dhanuka, Managing Director of Orchid Pharma, remarked, 'The EMA's recommendation for marketing authorization last month was a significant accomplishment, and the USFDA approval further solidifies Orchid's stance on the safety and necessity of the drug, especially in the face of rising Antimicrobial resistance.'"

"First discovered in 2008, it has been 16 years of painstaking effort to bring this product to market. Throughout this period, numerous tests were conducted to confirm its safety and effectiveness, gathering data for submission to regulatory bodies worldwide," he added.

"Enmetazobactam was originally developed in India by Orchid and subsequently licensed to Allecra Therapeutics for further advancement. With the potential to save numerous lives worldwide, this USFDA approval stands as a testament to Indian innovation. It is a moment of immense pride as India, often referred to as the pharmacy of the world, has now successfully created a new drug for the first time."