Orchid Pharma Granted DCGI Approval for Enmetazobactam: New Antibiotic Against AMR

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Orchid Pharma Receives DCGI Approval for New Antibiotic Against Antimicrobial Resistance

Team FS

06/Jun/2024

Key Points:

1: Orchid Pharma receives DCGI approval for Enmetazobactam, a new antibiotic to combat antimicrobial resistance.

2: Enmetazobactam is indicated for the treatment of severe infections, including complicated urinary tract infections and hospital-acquired pneumonia.

3: The approval signifies a significant milestone in India's fight against the AMR pandemic, providing patients with access to advanced and affordable treatment options.

Orchid Pharma, based in Chennai, India, has achieved a remarkable milestone in the fight against antimicrobial resistance (AMR) with the approval of its invented New Chemical Entity (NCE) Active Pharmaceutical Ingredient (API), Enmetazobactam, by the Drugs Controller General of India (DCGI). This groundbreaking approval paves the way for the manufacturing and marketing of Enmetazobactam as a potent antibiotic to combat AMR, addressing the urgent need for effective therapies against resistant bacteria in India.

Enmetazobactam has also received permission from the DCGI to manufacture and market the Finished Dosage Form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. This formulation is specifically indicated for the treatment of severe infections, including complicated urinary tract infections (cUTI), acute pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and bacteremia associated with or suspected to be associated with cUTI or HAP. With this approval, Orchid Pharma aims to improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options.

The approval of Enmetazobactam comes at a crucial time, as AMR is declared as the silent pandemic by the United Nations (UN) and World Health Organization (WHO). AMR poses a significant threat to global health, contributing to almost 5 million deaths in 2019 alone. Additionally, AMR has substantial economic costs, with estimates suggesting that it could result in US$1 trillion additional healthcare costs by 2050 and US$1 trillion to US$3.4 trillion GDP losses per year by 2030. Enmetazobactam, with its powerful treatment options against a range of severe infections caused by resistant bacteria, addresses a critical need in combating AMR and improving patient outcomes.

Mr. Manish Dhanuka, Managing Director of Orchid Pharma, expressed his personal fulfillment with Enmetazobactam's approval in India. He emphasized Orchid Pharma's commitment to innovation and providing advanced and affordable treatment options for patients in India. Orchid Pharma remains dedicated to research and development efforts to address unmet medical needs and enhance the treatment landscape for severe infections in the country.

Moving forward, Orchid Pharma looks forward to the successful launch and distribution of Enmetazobactam and its combination with Cefepime, aiming to further enhance the treatment landscape for severe infections in India. With this approval, Orchid Pharma reaffirms its position as a leading player in the pharmaceutical industry, driving innovation and improving patient care in India and beyond.

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Orchid Pharma Receives DCGI Approval for New Antibiotic Against Antimicrobial Resistance

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