Orchid Pharma has received approval from the Drugs Controller General of India (DCGI) to manufacture and market Enmetazobactam, a new chemical entity (NCE) and active pharmaceutical ingredient (API). Additionally, the DCGI has approved the production and marketing of a finished dosage form (FDF) of cefepime combined with Enmetazobactam as a dry powder injectable.
The antibiotic combination is indicated for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. It is also approved for use in hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia when these conditions are associated with or suspected to be linked to cUTI or HAP.
As reported by Pharmaceutical Technology, Orchid Pharma’s new combination drug meets a critical need for effective treatments against severe infections caused by resistant bacteria, addressing a significant concern in the global health community’s battle against antimicrobial resistance (AMR).
