Akums Drugs Achieves EU GMP Certification, Enhancing Global Expansion and Market Presence

Akums Drugs Secures EU GMP Certification, Strengthening Global Footprint

In a significant advancement for its global operations, Akums Drugs & Pharmaceuticals Ltd., India's foremost Contract Development and Manufacturing Organization (CDMO), attains European Union Good Manufacturing Practice (EU GMP) certification for two of its Indian manufacturing plants. This accomplishment not only emphasizes Akums' commitment to maintaining rigorous quality standards but also enhances its positioning within the competitive landscape of regulated pharmaceutical markets. The certification encompasses a renewal for its facility dedicated to solid oral dosage forms, which include tablets, capsules, and sachets, alongside a re-certification for its liquid oral dosage forms, such as solutions, syrups, and suspensions. With a production capacity that serves over 1.46 billion people, Akums' role in India's pharmaceutical sector is critical, as the company accounts for nearly 10% of the nation's total consumption.

The latest certifications facilitate Akums' strategic expansion plans, particularly in Europe and the UK. By entering the UK market with its recent approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the anticoagulant Rivaroxaban, Akums positions itself strategically within a sector valued at around USD 2.6 billion. This entry is not just a market penetration but signifies the company’s capability to navigate complex regulatory environments successfully. Sandeep Jain, Managing Director, asserts the imperative of building a global reputation that mirrors its domestic successes, while Co-Managing Director Sanjeev Jain points out that the firm's strengths—including its regulatory discipline and advanced development capabilities—are critical for their endeavors in regulated markets.

In tandem with its robust manufacturing capabilities, Akums is determined to replicate its domestic success on the global stage through a focus on quality and reliability. The company's ambition is to establish and nurture long-term partnerships that enhance its competitiveness and sustainability in international markets. Each step reflects India's growing prominence as the "Pharmacy of the World," highlighting Akums' pivotal role within this narrative. By ensuring compliance with international standards, the company not only bolsters its market entry but furthers the advancement of the global pharmaceutical industry as a whole.

On another note, Akums' recent successes underscore a broader trend within the Indian pharmaceutical landscape, where local companies are increasingly recognizing the importance of compliance and quality in expanding their footprints beyond national borders. As Akums drives towards international recognition, its proactive measures in regulatory adherence may inspire other manufacturers in India to enhance their capabilities, contributing to the overall growth and reputation of the Indian pharma sector on the world stage.