Akums has received its first product approval from the United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA) for rivaroxaban, with Akums as the Marketing Authorisation (MA) holder. This approval marks a milestone in Akums’s global expansion strategy and reinforces its commitment to deliver high-quality cardio-vascular medicines to patients across international markets.

The UK MHRA approval for rivaroxaban represents a significant milestone for Akums. This approval is the outcome of years of meticulous preparation, robust quality systems, and our strong regulatory capabilities. It reinforces Akums’s ability to consistently meet stringent global regulatory requirements and underscores our continued commitment to delivering high-quality, globally compliant pharmaceutical products,” said Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals.

Rivaroxaban is an oral anticoagulant prescribed for the prevention and treatment of thromboembolic disorders, including Non-Valvular Atrial Fibrillation (NVAF), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and clinically relevant cardiovascular risk reduction.

The UK cardiovascular market represents a substantial opportunity. According to industry data, the UK rivaroxaban market is projected to be one of Europe’s largest, supported by more than 1.1 million anticoagulation patients annually and a strong clinical preference for DOAC therapies in atrial fibrillation and thromboembolism. The broader European anticoagulant market accounts for nearly 30 percent of global rivaroxaban demand, driven by aging populations and rising cardiovascular disease prevalence. In the UK, rivaroxaban has consistently been among the top three most prescribed oral anticoagulants, with about 25 percent of community anticoagulant prescriptions attributable to rivaroxaban — highlighting its strong role in clinical practice.

“Today’s achievement is only the beginning. This comes shortly after our recent EU GMP approval for one of our plants and the renewal of GMP certification for another, further strengthening our global manufacturing and compliance capabilities. With this regulatory milestone, we are well-positioned to bring additional cardiovascular and other specialty medicines to European markets. It is a proud moment that validates our strategy of quality and global reach,” said Sandeep Jain, Director, Akums Drugs & Pharmaceuticals.