Orchid Pharma Secures USFDA Nod For Enmetazobactam

Photo:Representative Image

Orchid Pharma has been granted approval by the USFDA for their novel invention, Enmetazobactam. This comes soon after a recommendation for approval by the European Medicines Agency (EMA).

Enmetazobactam is the first beta-lactamase inhibitor to be completely invented in India. The approval of this product by the USFDA opens doors for its introduction into the largest pharmaceutical market in the world, the United States. Enmetazobactam is expected to be launched in the US market within the next few quarters.

The drug Exblifep, which contains Cefepime and Enmetazobactam, has received New Drug Approval (NDA) for injection-based treatment of complicated urinary tract infections (cUTI) in patients aged 18 and above. This treatment is effective against cUTI caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.

Orchid is an Indian pharmaceutical firm that has achieved a noteworthy milestone by inventing a product that has received New Drug Approval (NDA) from the USFDA. This is a major breakthrough in the global fight against Anti-Microbial Resistance (AMR) as this affordable and effective drug will help address the growing need for such treatments.

Orchid Pharma Ltd. (Orchid) was established in 1992 as an export-oriented unit (EOU). It is a vertically integrated company that covers the entire pharmaceutical value chain, from discovery to delivery. The company has established research, manufacturing, and marketing credentials across multiple therapeutic segments such as anti-infectives, anti-inflammatory, central nervous system (CNS), cardiovascular segment (CVS), nutraceuticals, and other oral and sterile products.