Akums Secures EU GMP Certifications for Two Haridwar Manufacturing Plants, Expanding European Market Access
核心洞察
Akums Drugs & Pharmaceuticals (搜索) has received renewed EU GMP certification for Plant 1 and first-time EU GMP approval for Plant 2 at its Haridwar facilities following European Medicines Agency (搜索) inspections.
Plant 1 maintains approval for oral solid dosage forms including tablets (搜索), hard gelatin capsules (搜索), and powder sachets (搜索), while Plant 2 gains certification for oral liquid formulations.
The dual certifications position Akums to expand its footprint across Europe and other highly regulated markets, supporting the company's exports to over 65 countries.
Akums Drugs & Pharmaceuticals (搜索) 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 first-time grant of EU GMP certification for its Plant 2 facility, both located at SIDCUL, Haridwar.
The certifications were awarded following recent inspections conducted by the European Medicines Agency (搜索) (EMA), which comprehensively assessed Akums' manufacturing operations, quality management systems, documentation practices, and overall compliance with EU GMP guidelines across both facilities.
Enhanced Manufacturing Capabilities
Plant 1, Akums' established manufacturing hub at Haridwar, continues to serve as a key facility for oral solid dosage forms. Under the renewed EU GMP certification, the approved scope includes tablets (搜索), hard gelatin capsules (搜索), and powder sachets (搜索). The facility is supported by advanced automation, precision manufacturing technologies, and robust quality systems designed to ensure consistent compliance with stringent international regulatory requirements.
Plant 2 has received EU GMP certification for the first time, with approval covering oral liquid dosage forms (搜索), including liquids, syrups (搜索), and suspensions (搜索). The facility features modern infrastructure and comprehensive quality control systems to support reliable and scalable manufacturing for regulated markets.
Strategic Market Expansion
With both plants now operating under EU GMP norms, Akums is positioned to expand its footprint across Europe and other highly regulated markets. The dual certification enables the company to offer a broader portfolio of oral formulations to global customers while meeting stringent international quality and compliance requirements.
"This milestone goes beyond regulatory approval—it reflects years of focused investment in quality systems, infrastructure, and people," said Sandeep Jain, Managing Director of Akums Drugs & Pharmaceuticals (搜索). "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."
Global Manufacturing Standards
Sanjeev Jain, Managing Director of Akums Drugs & Pharmaceuticals (搜索), emphasized the significance of the achievement: "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 (搜索), while enhancing our access to Europe and other regulated markets."
The approvals allow Akums to supply products manufactured at both Haridwar facilities to European markets, supporting the company's broader international expansion strategy as it continues to serve customers across more than 65 countries worldwide.