Orchid Pharma has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market its new chemical entity (NCE), the active pharmaceutical ingredient (API) Enmetazobactam.

The DCGI also approved the production and marketing of the finished dosage form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable.

The antibiotic drug combination is specifically indicated for complicated urinary tract infections (cUTI), including the treatment of acute pyelonephritis.

Other indications comprise hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia when associated with or suspected to be linked to either cUTI or HAP.

Orchid Pharma’s new combination drug addresses the urgent need for effective treatments against severe infections caused by resistant bacteria, a critical concern in the global health community’s fight against antimicrobial resistance (AMR).

The United Nations and the World Health Organization have declared AMR to be a “silent pandemic”, attributing to five million deaths in 2019.

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The company anticipates a successful launch and distribution of Enmetazobactam and its combination with Cefepime, aiming to enhance the treatment options available for serious infections in the country.

Orchid Pharma is the only Indian pharmaceutical company to have invented an NCE.

The molecule, which is out-licensed on a royalty basis, has already received approval in the US and Europe.

The company focuses on the production of high-quality cephalosporins, particularly sterile products. It operates one of only three US Food and Drug Administration-approved facilities globally for these products, which is the sole approved facility in India.

Orchid Pharma managing director Manish Dhanuka stated: “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.”