C2 PHARMA Receives CEP Approval For Tropicamide

C2 PHARMA the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs), proudly announces the approval of a Certificate of Suitability (CEP) for Tropicamide by the European Directorate for the Quality of Medicines and Health Care (EDQM). This is the first Tropicamide CEP for a European-based company, allowing C2 PHARMA to make the API commercially accessible to customers globally.

Tropicamide is used in eye exams and ophthalmic procedures to induce temporary mydriatic (pupil dilation) and cycloplegic effects (paralysis of the lens and pupil). “Our API meets European quality standards. This approval facilitates easier market access globally, confirming our compliance with stringent European standards,” states Katrien Oosterom, Senior Vice President of Regulatory Affairs. Tropicamide is manufactured by our longtime partner and CMO, Laurus Labs, and was added to our portfolio in October of 2022.
C2 PHARMA is ready to support Tropicamide across global markets, including the US, where the DMF has been available for reference since April 18, 2023. “This shows our commitment to continue serving the pharmaceutical industry in the ophthalmic sector worldwide,” states Andrew Badrot, CEO of C2 PHARMA. “This is our 11th approved CEP in 10 years and further solidifies our reputation for delivering high-quality, compliant pharmaceutical ingredients. Our consistent track record of approvals underscores our dedication to excellence and our capability to meet regulatory standards worldwide.”