Assamese Scientist Develops 1st Indian Antibiotic Approved By FDA After 16-Year Journey To Market

In a groundbreaking development, Assamese scientist Dr. Mukut Gohain co-invented and supported by Orchid Pharma of Chennai Chennai, India, have achieved a historic milestone as the United States Food and Drug Administration (USFDA) approved their novel antibiotic, 'Enmetazobactam'.

This marks the first time an antibiotic completely developed in India has received FDA approval, after a painstaking 16-year journey from inception to market.

Dr. Gohain, a highly accomplished scientist with a Ph.D. from NEIST, India, and extensive international experience, is the Principal Investigator and Head of Research & Development at CPT.

With a strong background in pharmaceutical research, including roles at Orchid Chemicals & Pharmaceuticals Ltd. and Sanmar Specialty Chemicals Ltd., Dr. Dr. Gohain leads a team in developing cost-effective industrial technologies for various active pharmaceutical ingredients (APIs).

He spearheads projects funded by the BILL and MELINDA GATES FOUNDATION, aiming to develop affordable commercial process technologies for life-saving drugs. Dr. Dr. Gohain is a prolific author and co-inventor of Enmetazobactam, an innovative antibiotic targeting multi-drug resistant gram-negative bacterial infections.

This breakthrough medication, which has completed Phase 3 clinical trials for urinary tract infections (UTI), had earned Fast Track status from the US FDA as a Qualified Infectious Disease Product (QIDP).

The announcement comes on the heels of a recent recommendation for approval by the European Medicines Agency (EMA), solidifying Enmetazobactam's global recognition. Developed as a Beta Lactamase Inhibitor, this innovative antibiotic addresses the pressing need for effective treatments amidst rising concerns of antimicrobial resistance (AMR).

Enmetazobactam, to be marketed as Exblifep (Cefepime and Enmetazobactam), has been authorized for use as an injection in patients aged 18 and above, specifically targeting 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.

The road to approval was arduous, involving rigorous testing and data generation to meet stringent regulatory standards. First discovered in 2008, Enmetazobactam's journey reflects the dedication and perseverance of the research team.

Dr. Mukut Gohain, one of the co-inventors of the antibiotic, expressed his pride, acknowledging the sacrifices and challenges overcome by the team throughout the process. He emphasized the significance of this achievement for Indian innovation, particularly in the biotech and pharmaceutical sectors.

Orchid Pharma's success not only signifies a major breakthrough in India's pharmaceutical landscape but also highlights the country's emergence as a global player in drug discovery and development. With Enmetazobactam poised to make a significant impact on healthcare worldwide, this milestone heralds a new era of innovation and progress in the fight against infectious diseases.

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