India’s Akums secures European Union GMP certification for oral solids, liquids

Indian contract development and manufacturing organization (CDMO) Akums Drugs & Pharmaceuticals has secured European Union Good Manufacturing Practice (EU GMP) certification for two manufacturing facilities in India.

The certification includes renewal for its oral solid dosage facility, which manufactures tablets, capsules and sachets, and new EU GMP approval for its oral liquid facility producing solutions, syrups, and suspensions. The approvals expand Akums’ ability to supply regulated European markets under EU quality and compliance standards, the company said.

Akums also reported receiving its first UK Medicines and Healthcare products Regulatory Agency approval for rivaroxaban, marking its entry into the UK anticoagulant market, which the company said is valued at approximately $2.6 billion. The approval supports its stated strategy to expand into EU and UK markets.

The milestone builds on a previously announced $200 million CDMO agreement signed in December 2024 with an undisclosed global pharmaceutical company to manufacture select oral liquid formulations for Europe. Under that agreement, Akums said it would initiate European regulatory approvals for its oral liquid site, with commercial supply expected to begin in 2027 and continue through 2032.

Akums operates 14 manufacturing plants in India, including 12 formulation facilities and two active pharmaceutical ingredient plants, with total annual production capacity exceeding 50 billion units, according to the company. Its portfolio spans more than 60 dosage forms and includes oral solids, liquids, and injectables.

The CDMO said the EU GMP certifications reinforce its strategy to increase participation in regulated global markets, while maintaining compliance with European manufacturing standards.