Exblifep (cefepime/enmetazobactam), a novel combination antibiotic for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative bacterial pathogens, subject to regulatory approval by the Ministry of Health of the Russian Federation.
Exblifep is a carbapenem-sparing antibiotic developed to address the growing clinical challenge posed by extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria in serious hospital infections. The product is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is included in IDSA and EUCAST treatment guidelines, and is the first new chemical entity originating from an Indian pharmaceutical company to receive both approvals.
Under the agreement, Pharmasyntez will hold the exclusive rights to register and commercialize Exblifep in Russia, with Orchid supplying the finished dosage form. The company said the partnership represents a potential opportunity of approximately $178 million over the first 10 years, driven by significant unmet clinical needs and large hospital procurement volumes in the Russian market.
Manish Dhanuka, managing director, Orchid Pharma, said, 'Our partnership with Pharmasyntez marks an important step in making Exblifep available to patients in Russia. Pharmasyntez's deep reach into the Russian hospital procurement system makes them the right partner to ensure this medicine gets to the clinicians and patients who need it.
Natalia Malykh, vice president of business development at the Pharmasyntez group, said, 'Antimicrobial resistance is one of the most significant challenges facing modern medicine, making the development of new antibiotics critical. Orchid Pharma has met this challenge by developing the novel antibiotic Exblifep (cefepime/enmetazobactam). This licensing agreement with Pharmasyntez enables Russian patients to gain access to modern antibacterial therapy.'
Orchid Pharma is a Chennai-based, fully vertically integrated pharmaceutical company with end-toend capabilities from Key Starting Materials (KSMs) to Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs), The company specializes in the development and manufacturing of complex injectable antibiotics.
The company reported a 6.68% increase in consolidated net profit to Rs 23.78 crore for the fourth quarter ended March 2026, compared with Rs 22.29 crore in the corresponding quarter last year. Revenue from operations rose marginally to Rs 237.61 crore in Q4 FY26 as against Rs 237.48 crore posted in the same period last year.
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