India : Orchid Pharma, headquartered in Chennai, India, has been granted approval by the United States Food and Drug Administration (USFDA) for its groundbreaking innovation, ‘Enmetazobactam.’ This achievement closely follows the recent endorsement for approval by the European Medicines Agency (EMA). Notably, Enmetazobactam stands as the first Beta Lactamase Inhibitor entirely developed in India.
- Orchid Pharma has made history by becoming the first Indian company to invent a product approved under the New Drug Application (NDA) process by the US Food and Drug Administration (USFDA).
- Additionally, Exblifep received approval from the European Medicines Agency in January 2024.
- The approval from the US Food and Drug Administration (USFDA) sets the stage for the introduction of Enmetazobactam into the United States, which is the largest pharmaceutical market globally. The product is anticipated to be launched in the US market within the next few quarters.
The New Drug Approval (NDA) permits the utilization of Exblifep (Cefepime and Enmetazobactam) as an injectable treatment for patients aged 18 years and above who are suffering from 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 has achieved a historic milestone as the first Indian company to invent a product that has obtained New Drug Approval (NDA) from the US Food and Drug Administration (USFDA). This achievement marks a significant advancement in meeting the worldwide demand for affordable and effective medications to combat Anti-Microbial Resistance (AMR).