New Delhi : Akums Drugs & Pharmaceuticals Ltd., India’s largest Contract Development and Manufacturing Organization (CDMO), has received a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its active pharmaceutical ingredient (API), Cefpodoxime Proxetil.
The CEP certification confirms that Akums’ manufacturing process and quality standards for Cefpodoxime Proxetil comply with the requirements of the European Pharmacopoeia. The approval is expected to support the company’s presence in regulated international markets and further strengthen its position as a reliable pharmaceutical manufacturing partner.
The development comes at a time when the global pharmaceutical industry is witnessing increasing demand for high-quality, compliant, and traceable APIs. The global API market is projected to continue its strong growth trajectory, driven by rising healthcare demand, increasing prevalence of infectious diseases, growing generic drug consumption, and stricter regulatory expectations across developed markets. Europe remains one of the most regulated pharmaceutical markets globally, with CEP approvals serving as an important benchmark for quality compliance and market access.
Cefpodoxime Proxetil, a widely used cephalosporin antibiotic, continues to remain relevant in the treatment of multiple bacterial infections, With antimicrobial therapies continuing to represent a significant share of pharmaceutical consumption globally, regulatory-compliant manufacturing capabilities are becoming increasingly critical for pharmaceutical companies seeking long-term global partnerships.
The development marks another step in Akums’ efforts to expand its international regulatory footprint and strengthen its globally compliant manufacturing capabilities. It also reflects the coordinated work of teams across Research & Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, and Operations.
Commenting on the development, Arushi Jain, Director, Akums Drugs & Pharmaceuticals Ltd., said: “The CEP approval for Cefpodoxime Proxetil reflects our continued focus on maintaining global quality and regulatory standards. As international regulatory expectations continue to evolve, approvals such as these demonstrate the strength of our manufacturing systems, scientific capabilities, and quality processes. This further supports our ability to cater to regulated markets and aligns with our vision of making high-quality and affordable pharmaceutical products accessible across geographies.
India continues to play a critical role in the global pharmaceutical supply chain, contributing significantly to worldwide generic medicine requirements and API manufacturing capabilities. With global pharmaceutical companies increasingly looking to diversify and secure compliant supply chains, Indian manufacturers with strong regulatory strength are expected to play an increasingly strategic role in regulated markets.
The CEP approval further adds to Akums’ portfolio of globally compliant products and highlights the company’s ability to meet international regulatory requirements.This development also aligns with Akums’ strategic focus on strengthening its presence across Europe and other regulated markets.
