Akums receives EDQM CEP approval for Cefpodoxime Proxetil API
Certification from the European Directorate for the Quality of Medicines & HealthCare supports the company's presence in regulated markets and its manufacturing capabilities for APIs
kums Drugs & Pharmaceuticals 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. According to the company, the approval is expected to support its presence in regulated international markets and strengthen its position as a pharmaceutical manufacturing partner.
The company stated that the development comes at a time when the global pharmaceutical industry is witnessing demand for compliant and traceable APIs. The global API market continues to be driven by healthcare demand, the prevalence of infectious diseases, generic drug consumption, and regulatory requirements across developed markets. Europe remains a regulated pharmaceutical market, with CEP approvals serving as a benchmark for quality compliance and market access.
Cefpodoxime Proxetil, a cephalosporin antibiotic, continues to be used in the treatment of bacterial infections. The company noted that antimicrobial therapies continue to account for a share of pharmaceutical consumption globally, making regulatory-compliant manufacturing capabilities important for pharmaceutical companies seeking global partnerships.
According to Akums, the approval marks another step in its efforts to expand its international regulatory footprint and strengthen its manufacturing capabilities. The company said the milestone reflects the 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, 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.”
The company stated that India continues to contribute to the global pharmaceutical supply chain through generic medicine requirements and API manufacturing capabilities. It added that as pharmaceutical companies seek to diversify and secure compliant supply chains, Indian manufacturers with regulatory capabilities are expected to play a role in regulated markets.
Akums said the CEP approval adds to its portfolio of compliant products and highlights its ability to meet international regulatory requirements. The company added that the development aligns with its focus on strengthening its presence across Europe and other regulated markets.