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, Orchid Pharma intends to improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options, said the company.
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, it added.
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.”
Orchid Pharma is one of the leading pharmaceutical companies in India head quartered in Chennai and involved in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals with exports spanning over 40 countries.
The pharma company’s consolidated net profit tumbled 49.19% to Rs 33.50 crore in Q4 FY24 as compared with Rs 65.93 crore in Q4 FY23. However, income from operations rose 3.43% YoY to Rs 217.10 crore in the quarter ended 31 March 2024.