- Akums Drugs & Pharmaceuticals Ltd. has secured European Union Good Manufacturing Practice (EU GMP) certification for two manufacturing facilities in India.
- The company has also received UK MHRA approval for Rivaroxaban, marking its entry into the UK anticoagulant market.
Akums Drugs & Pharmaceuticals Ltd., an India-based contract development and manufacturing organization (CDMO), has secured EU GMP certification for two of its manufacturing facilities located in India. The certification includes renewal for its oral solid dosage facility and fresh approval for its oral liquid facility. The development supports the company’s expansion into regulated European markets.
The renewed EU GMP approval covers tablets, capsules, and sachets, while the new certification applies to oral liquid formats including solutions, syrups, and suspensions. The approvals enable Akums to supply regulated European markets under recognized quality and compliance standards.
The company has also received its first UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for Rivaroxaban. This clearance marks Akums’ direct entry into the UK anticoagulant market, which the company states is valued at approximately USD 2.6 billion.
“We built scale, compliance and credibility in India. Our vision now extends with the same commitment to Europe and the UK. What we have achieved domestically, we are determined to replicate globally—with quality, reliability and long-term partnerships.”
Sandeep Jain, Managing Director
Akums operates 14 manufacturing plants, including 12 formulation facilities and two API plants, with an annual production capacity exceeding 50 billion units. The company supports more than 1,500 clients worldwide and maintains four R&D centers focused on concept-to-commercial scale-up across more than 60 dosage forms, including oral solids, liquids, injectables, nutraceuticals, and novel drug delivery systems.
