Akums Achieves EU GMP Certification, Boosting Global Market Ambitions and Opportunities

Akums Secures EU GMP Certification, Strengthening Global Market Presence

Akums Drugs & Pharmaceuticals Ltd., the largest Contract Development and Manufacturing Organization (CDMO) in India, announces a significant milestone in its international growth strategy with the achievement of European Union Good Manufacturing Practice (EU GMP) certification for two of its manufacturing facilities. This includes both the renewal of its oral solid dosage facility, which produces tablets, capsules, and sachets, and fresh certification for its oral liquid dosage facility, responsible for solutions, syrups, and suspensions. These approvals not only enhance Akums’ profile in regulated global markets but also reinforce its capability to deliver high-quality medicines to a larger audience, including the European Union and the UK.

The Indian pharmaceutical giant contributes nearly 10% of the country's total medicine consumption, addressing the needs of a population exceeding 1.46 billion. With a robust push into European markets, Akums recently penetrated the UK healthcare sector by obtaining Medicines and Healthcare products Regulatory Agency (MHRA) approval for Rivaroxaban, an anticoagulant valued at around USD 2.6 billion in the UK market. Sandeep Jain, Managing Director, articulates the company’s ambition to replicate its domestic success on the global stage by leveraging its scale, compliance, and credibility. Co-Managing Director Sanjeev Jain underscores the importance of the company's manufacturing capabilities, regulatory discipline, and development expertise as key enablers for an ambitious expansion into international markets.

Akums boasts an integrated and innovation-driven research and development ecosystem, which supports a diverse portfolio of over 20,000 stock-keeping units (SKUs). The firm's four advanced R&D centers enable it to maintain leadership across more than 60 dosage forms, including complex injectables and nutraceuticals. This end-to-end model allows for quicker technology transfers and strategic collaborations, positioning Akums to comply with stringent regulatory standards while ensuring quality control throughout its operations. The recent EU GMP certifications not only validate Akums’ manufacturing practices but are also expected to foster increased contract manufacturing opportunities and broaden therapeutic coverage, ultimately enhancing patient access to essential medicines globally.

In summary, Akums' proactive strategy towards gaining certifications and approvals is a testament to its commitment to quality and reliability. By focusing on regulated global markets, the company aims to position itself as a household name in the EU and UK while upholding the highest industry standards. As Akums moves forward, it reinforces India’s reputation as the "Pharmacy of the World," showcasing the country’s capability to deliver quality pharmaceuticals on an international scale.

In light of these developments, the industry looks keenly toward Akums’ continued growth and possible future expansions. The successful certification reflects not only an internal commitment to quality but also paves the way for long-term supply partnerships that could significantly impact global healthcare.