Orchid Pharma gets DCGI nod to market antibiotic drug combination

Orchid Pharma on Thursday said it has received approval from regulator DCGI to manufacture and market an antibiotic drug for the treatment of complicated urinary tract infections.

The Drug Controller General of India (DCGI) has granted permission to manufacture and market the finished dosage form of Cefepime and Enmetazobactam as a dry powder injectable, the drug firm said in a statement.

The formulation is indicated for the treatment of complicated urinary tract infections including acute Pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia (VAP), and bacteremia.

The DCGI has also granted approval for the production and marketing of its invented new chemical entity active pharmaceutical ingredient Enmetazobactam, 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 Managing Director Manish Dhanuka said.

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 the country, the drug firm stated.

Anti-Microbial resistance (AMR) is declared as the silent pandemic by 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 as the World Bank estimates that it 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.