Dr. Madhuresh Kumar Sethi is a seasoned leader with vast experience in the pharmaceutical and biopharmaceutical industries, making significant contributions to the evolution of major companies like Matrix, Mylan, and Viatris being instrumental in shaping the growth and success of these organizations. With a keen focus on API development, regulatory compliance, and intellectual property, his leadership has been pivotal in driving innovation and ensuring the long-term sustainability of key pharmaceutical products.
With expertise spanning biocatalysis, green chemistry, and peptide synthesis, he has successfully overseen the full spectrum of API development — from process research and impurity profiling to regulatory documentation, supporting global regulatory approvals.
One of Dr. Madhuresh’s standout strengths is his deep expertise in regulatory affairs and his ability to navigate complex global markets. His strategic approach in leading impurity profiling and safety studies has resulted in FDA and EU approvals for numerous products, a testament to his meticulous attention to detail and technical proficiency. Among his accomplishments, Dr. Madhuresh developed Iron Carbohydrate Complexes, for intravenous use, which went on to receive regulatory approval in the EU — further establishing his reputation as a leader in pharmaceutical innovation.
He also led the impurity profiling and safety studies for multiple injectable peptides, including Glucagon injectable, ensuring U.S. FDA approvals by meticulously characterizing related substances.
Beyond his technical expertise, Dr. Madhuresh has excelled in the legal aspects of the pharmaceutical industry. His leadership in defending Para IV litigations has been crucial in ensuring market exclusivity for essential generics. This ability to balance innovation with legal strategy has allowed him to secure first-to-market generics, including Lansoprazole, Sertraline, and Pitavastatin Calcium.
Dr. Madhuresh’s earlier roles at Aurobindo Pharma, Zydus Cadila, Wockhardt, and JK Industries further highlight his diverse skill set. Whether leading teams on non-infringing synthetic routes at Aurobindo Pharma or managing regulatory affairs and intellectual property at Zydus Cadila, he has consistently demonstrated an exceptional ability to drive results across various aspects of pharmaceutical development. His work at Wockhardt, focused on medicinal chemistry and Multiple Drug Resistance (MDR) research, and his contributions to cost-effective API process development at JK Industries, showcase his versatility and commitment to advancing the industry.
With proven track record of innovation, legal excellence, and leadership, Dr. Madhuresh remains a key figure in shaping the future of the pharmaceutical and biopharmaceutical sectors, ensuring that the companies he works with maintain a competitive edge in a dynamic and complex global market.