Akums Drugs & Pharmaceuticals has secured a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its active pharmaceutical ingredient (API), Cefpodoxime Proxetil.
Cefpodoxime Proxetil is a commonly used cephalosporin antibiotic for the treatment of multiple bacterial infections. The CEP certification confirms that Akums’ manufacturing process and quality standards for this API comply with the stringent requirements of the European Pharmacopoeia.
The approval is expected to strengthen Akums’ position in regulated international markets, particularly in Europe, and reinforce its reputation as a reliable pharmaceutical manufacturing partner.
Commenting on the achievement, 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.”
She added that the approval further supports the company’s ability to cater to regulated markets while aligning with its vision of making high-quality and affordable pharmaceutical products accessible globally.
The development comes amid growing global demand for high-quality, compliant, and traceable APIs. Europe remains one of the world’s most tightly regulated pharmaceutical regions, making CEP approvals a key benchmark for quality compliance and market access.
Akums said that the CEP approval further expands its portfolio of globally compliant products and also aligns with its strategic focus on strengthening its presence across Europe and other regulated markets
The company added that the achievement reflects the coordinated efforts of its Research & Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, and Operations teams.
India continues to play a significant role in the global pharmaceutical supply chain, particularly in generic medicines and API manufacturing. With international pharmaceutical companies increasingly seeking diversified and compliant supply chains, Indian manufacturers with strong regulatory credentials are expected to play a more strategic role in regulated markets.
