Akums Drugs & Pharmaceuticals Ltd. has received European Union Good Manufacturing Practice (EU GMP) certification for two of its production sites in India. The certifications strengthen the company’s ability to supply pharmaceutical products to regulated European markets while meeting internationally recognized quality standards.
The approvals include renewed EU GMP certification for Akums’ oral solid dosage facility, which produces tablets, capsules, and sachets, as well as new certification for its oral liquid manufacturing facility that handles solutions, syrups, and suspensions. These facilities now meet the compliance requirements necessary to export finished dosage forms to the European Union.
In addition to the EU approvals, Akums has gained its first UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for Rivaroxaban, a widely used anticoagulant. This marks the company’s direct entry into the UK pharmaceutical market, where the anticoagulant segment is valued at approximately USD 2.6 billion.
According to Akums Managing Director Sandeep Jain, the certifications align with the company’s long-term strategy to expand into regulated international markets while maintaining a focus on quality and reliability. Co-Managing Director Sanjeev Jain said the company’s progress reflects its manufacturing strength, regulatory discipline, and development capabilities, supporting a “calibrated yet ambitious” global expansion.
Akums operates four R&D centers with expertise across more than 60 dosage forms and manages a commercial portfolio exceeding 20,000 stock-keeping units (SKUs). Its operations cover complex injectables, oral solids, oral liquids, nutraceuticals, and novel drug delivery systems—supporting both domestic and international partners from formulation development through commercial production.