Akums Secures Key EU GMP Certifications for Two Haridwar Plants

Akums Drugs, a major Contract Development and Manufacturing Organization (CDMO), has made an important regulatory step, with the renewal of the European Union Good Manufacturing Practice (EU GMP) certification of their Plant 1 facility and initially the approval of the EU GMP certification of Plant 2 in the new location of Haridwar.

The consents are a result of successful inspections by the European Medicines Agency (EMA), which strengthens Akum's standing in heavily regulated pharmaceutical markets across the world.

The audits of the EU GMP measured the manufacturing activities, quality control systems, documentation standards and the adherence to strict European standards of both plants of Akums. Following the satisfactory inspection results, the regulators renewed the certification of Plant 1 and awarded new EU GMP approval to Plant 2, allowing both plants to work in conditions of the EU GMP.

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Both facilities in Haridwar are now certified, and Akums has an opportunity to increase its presence in Europe and other regulated markets and provide customers with a more diverse range of high-quality oral formulations. Plant 1 is still operating as an expert manufacturing facility of oral solid dosage products such as tablets, hard gelatin capsules, and powder sachets with high automation and accuracy manufacturing technology, which meets international standards.

Plant 2, which is EU GMP approved, can be used in the production of oral dosage forms in a liquid, syrup and suspension form. The facility has a state-of-the-art infrastructure and well-developed quality control measures to enable expansion of production to regulated markets.

Commenting on the development, Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., said: "This milestone goes beyond regulatory approval—it reflects years of focused investment in quality systems, infrastructure, and people. The renewal of EU GMP certification for Plant 1 and the new certification for Plant 2 strengthen our ability to serve regulated markets with confidence."

Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., added: “EU GMP is amongst the most rigorous global manufacturing standards, and achieving certification across two facilities simultaneously underscores the maturity of our compliance and operational capabilities.”