Orchid Pharma obtains DCGI nod for new antibiotic drug combination, shares up

Orchid Pharma Ltd.’s shares were up 4.26 per cent after the company secured approval from the Drugs Controller General of India (DCGI) to manufacture and market its new antibiotic drug combination of Cefepime and Enmetazobactam. The company said this marks the first time it has developed and produced an antibiotic drug combination in India.

The approval covers both the Active Pharmaceutical Ingredient (API) Enmetazobactam and the Finished Dosage Form (FDF) of the drug combination as a dry powder injectable. This formulation is intended for treating complicated urinary tract infections (cUTI), including acute pyelonephritis, hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and bacteremia associated with these conditions.

The company reported that it aims to enhance the treatment options for serious infections in India with this new antibiotic combination, addressing the critical need to combat antimicrobial resistance (AMR).

Manish Dhanuka, Managing Director of 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.”

The shares were up by 4.26 per cent to ₹1,040 at 12.35 pm on the BSE.

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