Akums Drugs & Pharmaceuticals Ltd has received its first product approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Rivaroxaban, marking a major regulatory milestone in the company’s global expansion strategy. Akums will serve as the Marketing Authorisation holder for the product in the UK.
The approval reinforces Akums’ regulatory and quality capabilities and strengthens its position in regulated international markets, particularly within Europe’s cardiovascular therapeutics segment. Rivaroxaban is an oral anticoagulant used for the prevention and treatment of thromboembolic disorders, including non-valvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and cardiovascular risk reduction.
The UK approval comes at a time of sustained demand for direct oral anticoagulants (DOACs), driven by an ageing population and the rising prevalence of cardiovascular diseases. The UK rivaroxaban market is among the largest in Europe, supported by more than 1.1 million anticoagulation patients annually and a strong clinical preference for DOAC therapies.
Across Europe, anticoagulants account for nearly 30% of global rivaroxaban demand, with rivaroxaban consistently ranking among the top three most prescribed oral anticoagulants in the UK.
The milestone follows recent EU GMP approval for one of Akums’ manufacturing facilities and the renewal of GMP certification for another, further strengthening the company’s manufacturing and compliance infrastructure. Together, these developments position Akums to expand its portfolio of cardiovascular and specialty medicines across European markets.
As India’s largest contract development and manufacturing organisation (CDMO), serving more than 1,500 customers globally, Akums continues to leverage its integrated manufacturing capabilities and regulatory expertise to support public health systems with reliable access to high-quality, internationally compliant pharmaceutical products.
