Orchid Pharma Receives DCGI Nod for Novel Antibiotic to Combat Rising Drug Resistance

Orchid Pharma, a leading pharmaceutical company, has secured a major milestone with the approval of its innovative antibiotic by the Drugs Controller General of India (DCGI). This approval paves the way for the manufacturing and marketing of Enmetazobactam, a New Chemical Entity Active Pharmaceutical Ingredient (API) discovered and developed entirely within India.

About Enmetazobactam

The DCGI approval extends to the Finished Dosage Form (FDF) of Cefepime and Enmetazobactam, a dry powder injectable combination therapy. This formulation targets complicated Urinary Tract Infections (cUTI), including acute Pyelonephritis, Hospital-Acquired Pneumonia (HAP), including Ventilator-associated pneumonia (VAP), and Bacteremia associated with these conditions. With this approval, Orchid Pharma aims to revolutionise the treatment landscape for serious infections within India, empowering healthcare professionals with a novel and effective therapeutic option.

Addressing the Global Challenge of AMR

The World Health Organization (WHO) and the United Nations have classified Anti-Microbial Resistance (AMR) as a “silent pandemic,” claiming nearly 5 million lives globally in 2019. Beyond its human cost, AMR poses a significant economic threat. The World Bank estimates that AMR could lead to an additional USD 1 trillion in healthcare expenses by 2050 and annual GDP losses ranging from USD 1 trillion to USD 3.4 trillion by 2030. Orchid Pharma’s new combination drug stands as a powerful weapon in this global fight, offering a potent solution against a broad spectrum of infections caused by resistant bacteria.

Enhancing the Treatment Landscape in India

Orchid Pharma expresses its commitment to the successful launch and distribution of Enmetazobactam, both as a standalone API and in its combination with Cefepime. This novel therapy holds immense promise for treating severe infections in India, providing patients with greater access to advanced and lifesaving options. This approval marks a significant victory in the ongoing battle against AMR and positions Orchid Pharma as a leader in developing innovative solutions for this critical global health challenge.

“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,” said Mr Manish Dhanuka, Managing Director of Orchid Pharma.

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