Akums Secures First UK MHRA Approval for Rivaroxaban

Delhi | February 10, 2026: Akums Drugs & Pharmaceuticals Ltd. has announced a significant regulatory milestone: the company 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 achievement marks a pivotal step in Akums’ global expansion strategy and underscores its dedication to delivering internationally compliant cardiovascular therapies.

Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., said: “The UK MHRA approval for Rivaroxaban is the outcome of years of meticulous preparation, robust quality systems, and strong regulatory capabilities. It validates our ability to consistently meet stringent global standards and reinforces our commitment to delivering high-quality pharmaceutical products worldwide.”

Sandeep Jain, Director, Akums Drugs & Pharmaceuticals Ltd., added: “This milestone follows our recent EU GMP approval and GMP certification renewals, strengthening our global compliance capabilities. With this approval, we are well-positioned to expand our cardiovascular and specialty medicines portfolio across European markets.”

About Rivaroxaban
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)
• Cardiovascular risk reduction

Market Opportunity

• The UK cardiovascular market represents one of Europe’s largest opportunities, with 1.1 million+ anticoagulation patients annually.
• Rivaroxaban is among the top three most prescribed oral anticoagulants in the UK, accounting for ~25% of community prescriptions.
• The broader European anticoagulant market contributes nearly 30% of global demand, driven by aging populations and rising cardiovascular disease prevalence.

Strategic Impact
This approval strengthens Akums’ ability to:

• Leverage its integrated CDMO capabilities.
• Expand presence in regulated international markets.
• Ensure consistent access to safe, high-quality, globally compliant medicines.

As India’s largest CDMO, serving 1,500+ customers globally, Akums continues to build on its strengths to deliver reliable pharmaceutical solutions across diverse geographies.

About Akums Drugs & Pharmaceuticals Ltd.
Akums Drugs & Pharmaceuticals Ltd. is India’s largest Contract Development and Manufacturing Organisation (CDMO), engaged in the development, manufacturing, and supply of pharmaceutical products across therapeutic categories. With a strong focus on quality, compliance, and innovation, Akums partners with global healthcare companies to deliver medicines that meet international standards.

🌐 Website: www.akums.in