C2 Pharma, a global manufacturer of ophthalmic and niche APIs, has secured a Certificate of Suitability (CEP) for Tropicamide from the European Directorate for the Quality of Medicines and Health Care (EDQM). This marks the first CEP for Tropicamide awarded to a European-based company, positioning C2 Pharma to offer the API to customers worldwide.
Tropicamide is utilized in eye examinations and ophthalmic procedures to induce temporary pupil dilation and paralysis of the lens and pupil. “This approval confirms that our API meets European quality standards, simplifying global market access and demonstrating our adherence to rigorous European regulations,” said Katrien Oosterom, Senior Vice President of Regulatory Affairs. Tropicamide is produced by C2 Pharma’s long-term partner, Laurus Labs, who added it to their portfolio in October 2022.
C2 Pharma is prepared to support Tropicamide in international markets, including the US, where the Drug Master File (DMF) has been available since April 18, 2023. “This achievement underscores our commitment to serving the global ophthalmic pharmaceutical sector,” remarked Andrew Badrot, CEO of C2 Pharma. Badrot added, “The approval of our 11th CEP in a decade reinforces our reputation for delivering high-quality, compliant pharmaceutical ingredients and reflects our consistent track record in meeting global regulatory standards”.
As reported by pharmabiz.com, C2 Pharma is a European pharmaceutical group specializing in the manufacturing and distribution of active pharmaceutical ingredients (APIs) and complex chemical compounds derived from both synthetic and natural sources.