Celebrating a Milestone: Cyclopentolate CEP approval
On June 5th 2023 we were thrilled to receive a CEP approval for Cyclopentolate
This is a significant team milestone for our team, as it marks the first API that was
spun out of our own R&D at ASM Research Chemicals in Hannover. The
development package (dev-pack) was sent to Laurus Labs in Dec 2019, just prior to
COVID, representing a remarkable turnaround of the process considering the
Cyclopentolate is a synthetic antagonist of muscarinic receptors used for effective
short-term paralysis of the ciliary eye muscles. It was initially developed in the 1950s
by Schieffelin1,2 as a chemical analogue of atropine, and has now emerged as
the preferred medication for patients of all age groups. This recognition has led to its
inclusion on the World Health Organization’s List of Essential Medicine. 3
Through this recent approval of the Certificate of Suitability (CEP) for Cyclopentolate
Hydrochloride, our team can now make this API commercially available throughout
Europe and even in regions beyond, such as South East Asia and Oceania. The
CEP approved of by EDQM is the second existing approval for Cyclopentolate
Hydrochloride and the only approval allowing our GMP certified manufacturing site
to supply to other markets.
To view the full press release click here, or learn more about how we are providing
reliable and high-quality API our ophthalmic customers have come to expect from
us, view the full portfolio of products and services.
- Patent US000002554511A, 1951.
- Treves, G. R., Testa, F. C., J. Am. Chem. Soc. 1952, 74(1), 46–48.
- World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533.