Obtaining a CEP for an active substance was preceded by a lengthy authentication process. Łukasiewicz – IChP is so far the only manufacturer in the world that has received this certificate for API Tacalcitol, used in medicinal products indicated for the treatment of dermatological diseases. We are very proud of our achievement, we worked hard to have it!
Lukasiewicz – ICI produces active pharmaceutical ingredients (APIs) in several therapeutic areas: oncology (imatinib, sunitinib, anastrozole), vitamin D metabolites (alfacalcidol, tacalcitol and others), cardiology (carvedilol, clopidogrel), ophthalmics (latanoprost, brinzolamide), antipsychotics (olanzapine) in original polymorphic form and many other APIs for which it has ready-to-implement technologies.
– It took a great deal of effort and commitment on the part of our team to obtain CEP certification for Tacalcitol,” says Wojciech Maszewski, director of the Pharmaceutical Products Department at Lukasiewicz – ICI, and adds: – This synthesis is extremely complicated and time-consuming, and like other API syntheses, we have to perform it under a strict regime of GMP requirements. In addition, all analytics and product documentation had to be verified with the European EDQM agency, which was difficult and often kept us awake at night, but in the end we succeeded! We are very proud of this. As a result, firstly, we have confirmed the quality of our work in the highest European standards, and secondly, our customers – manufacturers of drugs produced on the basis of our Tacalcitol – have a tremendously simplified registration path, which saves them time and significantly reduces their costs.