C2 PHARMA, the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs), announces the approval of a Certificate of Suitability (CEP) for oxybuprocaine hydrochloride by the European Directorate for the Quality of Medicines and Health Care (EDQM). Oxybuprocaine hydrochloride is now commercially available to customers in Europe and other global markets with mutual recognition of the CEP.
Oxybuprocaine hydrochloride, also known as Benoxinate, is a synthetic local anaesthetic used in ophthalmology and otolaryngology for minor surgical procedures. Currently, there are only two approved CEPs for oxybuprocaine HCL, with C2 PHARMA holding the second. “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.
C2 PHARMA is the global leader in ophthalmic active pharmaceutical ingredients (APIs). Founded in 2014 and headquartered in Cork, Ireland, C2 PHARMA ensures a consistent supply of high-quality APIs at competitive prices, serving over 200 pharmaceutical companies worldwide.