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- This recognition from the European Medicines Agency (EMA) is one of the most demanding regulatory certifications.
- With this milestone, the company reinforces its commitment to operational excellence.
Sylentis, empresa biofarmacéutica especializada en terapias basadas en ARN, filial de PharmaMar (MSE:PHM), ha anunciado que su nueva planta, en la localidad madrileña de Getafe, dedicada a la producción de fármacos basados en ARN ha obtenido la certificación de Normas de Correcta Fabricación (NCF) de la Agencia Europea de Medicamentos (EMA).
The NCF certification, granted by the Spanish Agency for Medicines and Health Products (AEMPS), which carried out the audit, confirms that the plant complies with the highest international standards of quality, safety and control in all stages of the manufacture of medicines and active pharmaceutical ingredients.
Andreas Segerros, Chief Executive Officer of Sylentis, comments that “This certification allows us to supply products manufactured at these facilities to companies in the highly regulated European market and worldwide. This opens the door to new international collaborations, improves Sylentis’ competitiveness and strengthens the confidence of our partners and customers in products manufactured according to European standards.”.
The pharmaceutical plant covers an area of 6,000 m² and has been built to the highest standards of sustainability and digitalisation to achieve maximum efficiency. The facility serves a dual purpose: manufacturing RNA-based medicines for third parties and providing manufacturing services for Sylentis’ research and clinical projects. The new plant, backed by Sylentis’ more than ten years of manufacturing experience, significantly increases its production capacity.
Esta planta se construyó a través del proyecto Syoligo, financiado por el fondo NextGenerationEU del Ministerio de Ciencia, Innovación y Universidades y gestionado por el CDTI (Centro para el Desarrollo Tecnológico e Innovación).
