Farmak has received a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for its in-house produced active pharmaceutical ingredient (API) — naphazoline nitrate. The certificate was issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in September 2025. The company obtained its first CEP in 2024 for the API dimetindene maleate.
The active pharmaceutical ingredient naphazoline nitrate is used in nasal drops indicated for acute rhinitis, as an adjuvant in the treatment of inflammation of the paranasal sinuses and middle ear, and to reduce mucosal swelling during diagnostic procedures.
Only two companies in the world hold a CEP for this API — and Farmak is among them. The company received the certificate without any observations, confirming the high professional standards and competence of Farmak’s specialists.
Obtaining the CEP opens new opportunities for Farmak in the European market. The certificate confirms that the production and quality of the API comply with the highest standards established in the EU. It also significantly simplifies the registration procedures for finished pharmaceutical products containing the certified ingredient and enables Farmak to accelerate their time to market in Europe.
