Orchid Pharma Bags DCGI Nod To Manufacture Antibiotic Drug

Orchid Pharma has secured Drugs Controller General of India (DCGI) endorsement for the manufacturing and promoting of its invented New Chemical Entity active pharmaceutical ingredient (API), enmetazobactam. DCGI has  conceded consent to produce and market finished dosage form (FDF) of cefepime and enmetazobactam as a dry powder injectable.

The definition is shown for the treatment of complicated urinary tract infections (cUTI) including intense pyelonephritis, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP), and bacteremia when it is related or thought to be related with either confounded urinary tract infections or hospital-acquired pneumonia.

Anti-microbial resistance (AMR) is announced as the quiet pandemic by UN and WHO and it has added to just about 5 million deaths in 2019. AMR has significant financial consequences, including disability and death. The World Bank assesses that AMR could bring about US$ 1 trillion extra medical care costs by 2050, and US$ 1 trillion to US$ 3.4 trillion GDP (Gross domestic product) losses per year by 2030.

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.”