Cayman Chemical Receives CEP for Latanoprost API from EDQM

ANN ARBOR, MI, SEPTEMBER 12, 2023—Cayman Chemical, a world leader in the manufacture of prostaglandins for both research use and as active pharmaceutical ingredients (APIs), has been granted a Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) by the European Directorate for the Quality of Medicines and HealthCare (EDQM) for its latanoprost API, effective August 28th, 2023. Cayman Chemical is the first company in the USA to receive a CEP for latanoprost.

A CEP is granted to a manufacturer of an active substance that has demonstrated that the chemical purity and microbiological quality of their substance is adequately controlled by the relevant European Pharmacopoeia monograph and meets European Union (EU) pharmaceutical legislation requirements.

A CEP harmonises data exchange between regulatory agencies and industry. It confirms that the active substance produced by the manufacturer has met quality standards under Good Manufacturing Practices (GMPs) that make it appropriate and safe for use in medicines. A CEP may be used to simplify the drug application process, as the CEP can be used in the application dossier for marketing authorization, making it easier to receive approval from licensing authorities.

CEPs are recognised by the signatory parties of the Convention on the Elaboration of a European Pharmacopoeia, which includes all European Pharmacopoeia member states and the EU. They are also accepted (some with conditions) by other countries and regulatory authorities. The EDQM has also established a list of authorities and organizations that are allowed access to certification assessment and/or inspection reports from manufacturer sites.