Akums Secures First UK MHRA Approval for Rivaroxaban
New Delhi: Akums Drugs & Pharmaceuticals Ltd. 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.
The approval marks a significant milestone in the company’s global expansion strategy and strengthens its presence in regulated international markets.
Commenting on the development, Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., said, “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 strong regulatory capabilities. It reinforces Akums’ ability to consistently meet stringent global regulatory requirements and underscores our continued commitment to delivering high-quality, globally compliant pharmaceutical products.”
Rivaroxaban is an oral anticoagulant indicated for the prevention and treatment of thromboembolic disorders, including non-valvular atrial fibrillation (NVAF), deep vein thrombosis (DVT), pulmonary embolism (PE), and cardiovascular risk reduction.
The UK cardiovascular market presents a substantial opportunity. Industry data indicates that the UK rivaroxaban market is among the largest in Europe, supported by more than 1.1 million anticoagulation patients annually and strong clinical preference for direct oral anticoagulants (DOACs) in atrial fibrillation and thromboembolism. The broader European anticoagulant market accounts for nearly 30% of global rivaroxaban demand, driven by ageing populations and the rising prevalence of cardiovascular diseases. In the UK, rivaroxaban remains one of the top three most prescribed oral anticoagulants, accounting for nearly 25% of community anticoagulant prescriptions.
Sandeep Jain, Director, Akums Drugs & Pharmaceuticals Ltd., said, “Today’s achievement is only the beginning. This comes shortly after our recent EU-GMP approval for one of our plants and 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 specialty medicines to European markets. It is a proud moment that validates our strategy of quality and global reach.”
Public health systems across the UK and Europe continue to require consistent access to high-quality pharmaceutical therapies. With this approval, Akums aims to leverage its integrated CDMO capabilities and regulatory expertise to expand its footprint in regulated markets. As India’s largest CDMO, serving over 1,500 customers globally, the company remains focused on ensuring reliable access to safe, high-quality, and internationally compliant medicines worldwide.
