Akums Drugs, a leading Contract Development and Manufacturing Organization (CDMO), has achieved a major regulatory milestone with the renewal of European Union Good Manufacturing Practice (EU GMP) certifications for its two plants in Haridwar. 

 

The approvals for its Plant 1 facility and the first-time EU GMP certification for its Plant 2 facility in SIDCUL follow successful inspections conducted by the European Medicines Agency (EMA).

 

The EU GMP audits evaluated Akums’ manufacturing processes, quality management systems, documentation standards, and overall compliance with stringent EU GMP guidelines across both facilities. Based on the satisfactory inspection outcomes, regulators renewed the certification for Plant 1 and granted fresh EU GMP approval to Plant 2.

 

With both Haridwar facilities now operating under EU GMP norms, Akums is positioned to significantly expand its footprint in Europe and other highly regulated markets, offering customers a wider portfolio of high-quality oral formulations.

 

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms. Under the renewed certification, the facility is approved to manufacture tablets, hard gelatin capsules, and powder sachets, supported by advanced automation, precision manufacturing technologies, and robust quality systems aligned with international regulatory standards.

 

Plant 2, which has now secured EU GMP certification, is approved for the manufacture of oral liquid dosage forms, including liquids, syrups, and suspensions. The facility is equipped with modern infrastructure and comprehensive quality control systems to enable reliable and scalable production for 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. 

 

"As an organisation supplying a significant share of India’s domestic pharmaceutical needs and exporting to over 65 countries, this achievement supports our long-term partnerships and sustained global growth.”

 

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. 

 

"This enables our partners to rely on Akums for consistent quality across both oral solid and oral liquid dosage forms, while enhancing our access to Europe and other regulated markets. Our focus remains on building a globally respected manufacturing platform that delivers safe, effective, and affordable medicines worldwide.”

 

EU GMP certification is regarded as one of the highest benchmarks in pharmaceutical manufacturing and is recognized by regulatory authorities across Europe and several other regulated regions.