C2 PHARMA, a company that manufactures and supplies ophthalmic active pharmaceutical ingredients (APIs), has received a Certificate of Suitability (CEP) for Cyclopentolate Hydrochloride by the Quality of Medicines & Health Care (EDQM). This is the second ever CEP granted by the European Directorate for Cyclopentolate Hydrochloride, allowing C2 PHARMA to make the API commercially accessible to customers throughout Europe, Southeast Asia, Oceania and beyond.

The synthesis of the API was developed by a C2 PHARMA affiliate, ASM Research Chemicals, in Hannover, Germany. The manufacturing process was documented by ASM in a development pack (dev-pack) and transferred to Indian manufacturing partners, Laurus Labs Ltd., to leverage their state-of-the-art GMP manufacturing facilities and operations.

“Cyclopentolate Hydrochloride is used to dilate (enlarge) the pupil of the eye and to temporarily paralyze the lens for eye diagnostics,” said James Lawler, general manager. “Classed as an antimuscarinic agent, the API is immediately available for commercial supply globally from our warehouse location in Frankfurt, Germany. With this approval, C2 PHARMA is ready to provide the reliable and high-quality API our ophthalmic customers have come to expect from us.”

Katrien Oosterom, vice president of regulatory affairs said, “A thorough review by the European Agency has confirmed compliance with the strictest quality standards and this CEP complements our US-DMF for Cyclopentolate Hydrochloride and guarantees a global availability of the API. “Working throughout the challenging times of COVID, our team was fortunate to receive an expedited approval process. From the early development work at ASM to receiving the CEP approval took only 3.5 years. Our CEP approval was obtained on the 5th of June 2023 and is now published on the EDQM website.”