Orchid Pharma has received Drugs Controller General of India (DCGI) approval for the manufacturing and marketing of its invented New Chemical Entity Active Pharmaceutical Ingredient (API), Enmetazobactam.
DCGI has also granted permission to manufacture and market Finished Dosage Form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. This formulation is indicated for the treatment of complicated Urinary Tract Infections (cUTI) including acute Pyelonephritis, HospitalAcquired Pneumonia (HAP) including Ventilator-associated pneumonia (VAP), and Bacteremia when it is associated or suspected to be associated with either complicated urinary tract infections or hospital-acquired pneumonia.
With this approval, Orchid Pharma intends to improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options.
Anti-Microbial resistance (AMR) is declared as the silent pandemic by UN and WHO and it has contributed to almost 5mn deaths in 2019. In addition to death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in US$ 1 trillion additional healthcare costs by 2050, and US$ 1 trillion to US$ 3.4 trillion gross domestic product (GDP) losses per year by 2030.
This new Combination Drug, provides a powerful treatment option against a range of severe infections caused by resistant bacteria, addressing a critical need in combating antimicrobial resistance.