Orchid Pharma receives DCGI approval for its antibiotic drug combination of Cefepime and Enmetazobactam (NCE)

Its reportedly company’s first invented and made-in-India drug 

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, Hospital-Acquired 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, the Chennai – based company, aims 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 the UN and WHO and it has contributed to almost 5 million deaths in 2019. In addition to death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in USD 1 trillion additional healthcare costs by 2050, and USD 1 trillion to USD 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.

 Speaking on the approval, Manish Dhanuka, Managing Director, Orchid Pharma, said, “Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India. Orchid Pharma is committed to innovation and is poised to provide an effective solution for patients suffering from severe infections, particularly in the face of rising antimicrobial resistance. We continue our dedicated efforts towards research and development to address unmet medical needs.”

“The company looks forward to the successful launch and distribution of Enmetazobactam and its combination with Cefepime for enhancing the treatment landscape for severe infections in India,” the statement further informs.