Akums receives first UK MHRA approval for Rivaroxaban

Akums Drugs & Pharmaceuticals 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.

Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals 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 our 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 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.

Sandeep Jain, Director, Akums Drugs & Pharmaceuticals said, “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.”

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