Orchid Pharma and Pharmasyntez Ink Agreement to Commercialize Exblifep in Russia

Orchid Pharma and Pharmasyntez Ink Agreement to Commercialize Exblifep in Russia​

Orchid Pharma Ltd., a leading pharmaceutical company specializing in complex injectable antibiotics, has signed a licensing and supply agreement with Pharmasyntez JSC of Russia. The deal covers the commercialization of Exblifep® (cefepime/enmetazobactam) across the Russian market.

Exblifep®, a novel combination antibiotic, is designed to treat complicated urinary tract infections (cUTI) and hospital-acquired or ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gramnegative bacterial pathogens. The agreement establishes Pharmasyntez as the exclusive rights holder for registering and commercializing Exblifep in Russia, with Orchid Pharma providing the finished dosage form.

The partnership represents a substantial market opportunity, estimated at approximately USD 178 million over the first decade of the agreement, reflecting the scale of unmet clinical need and procurement volumes within the Russian healthcare system.

Exblifep is noted as a carbapenem-sparing antibiotic developed to combat the growing challenge of ESBL-producing Gram-negative bacteria in serious hospital infections. The product has already received approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), marking it as the first new chemical entity originating from an Indian pharmaceutical company to achieve these dual approvals.

Manish Dhanuka, Managing Director at Orchid Pharma Ltd., stated that the partnership marks a crucial step toward making Exblifep accessible in Russia. He highlighted that Pharmasyntez's deep penetration into the Russian hospital procurement system makes them the ideal partner to deliver the medicine to clinicians and patients who require it.

Natalia Malykh, Vice President of Business Development at the Pharmasyntez group, emphasized the global significance of the achievement. She noted that antimicrobial resistance is a critical challenge in modern medicine, affirming that the licensing agreement enables Russian patients to access this advanced antibacterial therapy.

Company Profiles and Context​

Orchid Pharma Limited:
Orchid is a fully vertically integrated pharmaceutical company, managing processes from Key Starting Materials (KSMs) through Active Pharmaceutical Ingredients (APIs) to Finished Dosage Forms (FDFs). The company focuses on complex injectable antibiotics and operates globally approved manufacturing facilities that adhere to USFDA and EU-GMP standards. Orchid is also recognized as the first Indian pharmaceutical company to invent an NCE approved in both Europe and the United States, with the product commercially marketed across India and Europe.

Pharmasyntez Group:
Pharmasyntez is a prominent Russian biopharmaceutical entity engaged in research, manufacturing, and distribution of socially significant pharmaceuticals. The Group operates eight manufacturing facilities throughout Russia, boasting an annual production exceeding 100 million packages. For 2025, Pharmasyntez projects consolidated revenue of 50.5 billion rubles. It has invested over 25 billion rubles into the production and development within the Russian pharmaceutical industry.

Sathguru Management Consultants advised Orchid Pharma on this transaction.

ORCHPHARMA Stock Price Movement​

Shares of Orchid Pharma Limited slipped today by 1.24% to close at ₹924.65. The stock traded within a range of ₹916.75 and ₹958.35, with a total volume of 49,215 shares recorded during the session.