C2 PHARMA Secures EDQM CEP Approval for Oxybuprocaine Hydrochloride

C2 PHARMA has disclosed the approval of a Certificate of Suitability (CEP) for Oxybuprocaine Hydrochloride from the European Directorate for the Quality of Medicines and Health Care (EDQM). Oxybuprocaine Hydrochloride is presently accessible to consumers in Europe and various international markets with reciprocal acknowledgment of the CEP. Oxybuprocaine Hydrochloride, commonly referred to as Benoxinate, is a man-made local anesthetic applied in ophthalmology and otolaryngology for minor surgical operations. At present, there are just two sanctioned CEPs for Oxybuprocaine HCL, and C2 PHARMA possesses the second one.

“Achieving this approval demonstrates our dedication to meeting the highest regulatory standards and positions us as a key player in the market for this product,” states Katrien Oosterom, senior vice-president of regulatory affairs. Oxybuprocaine Hydrochloride is manufactured by C2 PHARMA’s trusted CMO, Laurus Labs, at their new site in Anakapalli, India.

The application for Oxybuprocaine HCL, submitted in July 2024, has been approved in a record review timeline of just seven months. It underscores the quality and compliance of this submission. “This achievement highlights our company's commitment to excellence, efficiency, and integrity, further solidifying our reputation as the trusted leader in ophthalmic APIs,” states Andrew Badrot, CEO of  C2 PHARMA. The CEP approval was secured on January 9th, 2025, and is officially published on the EDQM website.