Akums Secures EU GMP Milestone for Haridwar Plants, Setting Stage for Global Growth

India’s largest contract manufacturer clinches dual European regulatory approvals, boosting export potential and reinforcing quality credentials.

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Akums Drugs & Pharmaceuticals Ltd., one of India’s leading Contract Development and Manufacturing Organisations (CDMOs), has achieved a significant regulatory milestone with European Union Good Manufacturing Practice (EU GMP) certification for two of its manufacturing facilities in Haridwar, Uttarakhand — a development that broadens the company’s ability to serve highly regulated global markets with pharmaceutical products.

The approvals include a renewal of the EU-GMP certification for the company’s oral solid dosage facility — which manufactures products such as tablets, capsules, and sachets — and a fresh EU-GMP certification for its oral liquid facility, covering syrups, solutions, and suspensions.

EU GMP certification is widely recognised as one of the most stringent quality benchmarks in pharmaceutical manufacturing, ensuring rigorous adherence to manufacturing practices, hygiene controls, documentation standards, and compliance with European regulatory norms.

The certifications, which are valid for three years, will empower Akums to supply products manufactured at both Haridwar facilities to European Union regulated markets and other countries that follow EU-GMP norms, significantly strengthening the company’s export and global manufacturing credentials.

Commenting on the development, Sandeep Jain, Managing Director of Akums Drugs & Pharmaceuticals, framed the certification as more than a regulatory formality but a reflection of long-term strategic investment:

“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.”

Jain added that the dual certification — renewal for Plant 1 and new approval for Plant 2 — fortifies Akums’s operational capabilities and positions the company to serve regulated markets with confidence.

In addition to the EU GMP milestone, Akums has also marked its entry into the UK market with its first approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the anticoagulant drug Rivaroxaban — a validation of its broader regulatory ambition beyond EU borders.

Operating 14 world-class manufacturing plants — including 12 formulation facilities and two API plants — Akums serves more than 1,500 clients worldwide, with an annual capacity of over 50 billion units across diverse dosage forms.

The certification milestone arrives as Indian pharmaceutical manufacturers increasingly pursue global regulatory approvals to deepen their reach into developed markets — a trend driven by rising demand for high-quality, affordable generics and contract manufacturing services from Europe, the UK, and other regulated regions.

By aligning its Haridwar plant operations with EU-GMP and UK MHRA standards, Akums strengthens its competitive position in the global CDMO landscape, potentially unlocking new business opportunities and partnerships across regulated pharmaceutical markets.