Akums Strengthens Presence in Regulated Markets with EU GMP Approvals for 2 Haridwar Plants

New Delhi, 23 Jan 205: Akums Drugs & Pharmaceuticals Ltd., a leading Contract Development and Manufacturing Organization (CDMO), has achieved a significant regulatory milestone with the renewal of European Union Good Manufacturing Practice (EU GMP) certification for its Plant 1 facility and the grant of EU GMP certification for its Plant 2 facility, both located in SIDCUL, Haridwar. The certifications were awarded following recent inspections conducted by the European Medicines Agency (EMA).

The EU-GMP audits comprehensively assessed Akums’ manufacturing operations, quality management systems, documentation practices, and compliance with EU GMP guidelines across both facilities. Based on the satisfactory inspection outcomes, the Drug agency renewed the EU GMP approval for Plant 1 and granted fresh certification for Plant 2.

With both facilities now operating under EU GMP norms, Akums is well positioned to expand its presence across Europe and other highly regulated geographies, supporting customers with a broader portfolio of high-quality oral formulations.

Akums Manufacturing Plant 1, located in SIDCUL, Haridwar, continues to serve as a key manufacturing hub for oral solid dosage forms. Under the renewed EU GMP certification, the approved scope includes tablets, hard gelatin capsules, and powder sachets. The facility is supported by advanced automation, precision manufacturing technologies, and robust quality systems designed to ensure consistent compliance with stringent international regulatory requirements.

Another Manufacturing Plant (Plant 2) which received EUGMP Certification, The newly granted EU GMP certification covers oral liquid dosage forms, including liquids, syrups, and suspensions. The facility features modern infrastructure and comprehensive quality control systems to support reliable and scalable manufacturing for regulated markets.

Commenting on the development, Mr. 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.”

Mr. 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 widely recognized as one of the highest benchmarks in pharmaceutical manufacturing and is accepted by regulatory authorities across Europe and several other regulated regions. The certification enables Akums to supply products manufactured at both Haridwar facilities to these markets and supports the company’s continued international expansion.