As Berko expands its pharmaceutical portfolio and contract manufacturing footprint across 23 countries, securing a reliable, cost-effective API source is critical. With Ribociclib (Kisqali) patent expiration approaching (approx. 2029-2030), early supplier qualification will be decisive for a smooth generic launch. We offer GMP-grade Ribociclib API with full DMF/CEP/ASMF documentation and robust nitrosamine control, ensuring compliance for both highly regulated and emerging markets.

Our supply chain combines commercial-scale capacity with flexible batch sizes (clinical to industrial), competitive pricing, and dependable delivery schedules—enabling you to manage pre-launch stability batches, registration, and future commercial production without supply-chain risk. We can also align technical support with Berko’s existing quality and R&D processes to shorten qualification time.

May I send a detailed dossier summary and arrange a call to discuss your specific requirements? I am happy to provide samples for evaluation and propose a tailored supply agreement.