C2 Pharma, a global manufacturer and supplier of ophthalmic and niche APIs, has received a certificate of suitability (CEP) for Tropicamide by the European Directorate for the Quality of Medicines (EDQM).
This is the first certificate awarded by the regulatory board for Tropicamide in Europe, which allows the company to make the API commercially accessible to customers globally.
Tropicamide is utilised by ophthalmologists to include temporary pupil dilation, as well as the paralysis of the lens and pupil.
“The approval of Tropicamide facilitates easier market access globally, and we are glad to be compliant with European standards,” states Senior Vice President of Regulatory Affairs, Katrien Oosterom.
“Tropicamide is manufactured by our longtime partner and CMO, Laurus Labs, and was added to its portfolio in October 2022. This is our 11th approved CEP in 10 years; our consistent track record of approvals highlights our dedication to meeting regulatory standards globally,” adds Katrien.
According to C2 Pharma, the company is ready to support the rollout of Tropicamide worldwide.
