Farmak International Strengthens UK Portfolio with Two New MHRA-Approved Therapies

Farmak International has received marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion and Cetirizine Dihydrochloride 10 mg film-coated tablets. These latest approvals follow the company’s recent announcement of three other newly authorised medicines in the United Kingdom of Great Britain and Northern Ireland, underscoring Farmak International’s rapid expansion in one of Europe’s most competitive markets.

Dexmedetomidine 100 micrograms/ml
• Sedation of adult ICU patients requiring a target depth of RASS 0 to -3
• Procedural (awake) sedation of non-intubated adult patients during diagnostic or surgical interventions

Cetirizine Dihydrochloride 10 mg
• Relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis
• Relief of urticaria symptoms

Momentum in the United Kingdom

Strategic groundwork laid in 2024, including the acquisition of A&S Pharma Holdings Ltd and the award of Manufacturer’s/Importation Authorisation and Wholesale Distribution Authorisation (MIA and WDA(H)) earlier this year, has enabled Farmak International to accelerate dossier submissions. In just a few months, the company has secured five MHRA approvals across respiratory, allergy, analgesia, and critical-care segments, reinforcing its commitment to supply sustainable, high-quality generics for the NHS.

By adding these two products, Farmak International not only widens treatment choice for clinicians today but also lays the groundwork for a pipeline of launches we expect to unfold over the year ahead. Our roadmap includes high-value ICU medicines and specialty generics that will further support NHS sustainability and patient access.

Marc Hourigan Head of UK & Republic of Ireland

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About Farmak Group

Farmak Group is a global pharmaceutical business tracing its roots to Ukraine since 1925. With production facilities in two European countries and 13 international offices, the Group exports products to 60 countries across Europe, Asia, the Middle East and Africa, and Latin America.

About Farmak International

Farmak International, a brand managed by FARMAK AG and headquartered in Switzerland, leads Farmak Group’s global strategy, overseeing business operations, asset management, and expansion into international markets.

Healthcare-professional information and forward-looking statements
This communication is intended solely for healthcare professionals. Medicines described must be used in accordance with local prescribing information. This release may contain forward-looking statements; actual results could differ due to factors beyond the company’s control. Farmak International undertakes no obligation to update forward-looking statements except as required by law.