Louvain-la-Neuve, June 19th, 2024 – Vinorelbine is an important drug substance used to treat breast and lung cancers. Minakem is the sole API manufacturer located in Europe.
This molecule remains complex because the raw material is extracted from the Madagascar periwinkle plant, making it subject to seasonality and climatic events. This results in a two-year supply chain timeline, requiring the securing of plants at the farmers’ level well in advance and the necessity to build safety stocks at various points in the manufacturing process.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently validated the update of the Certificate of Suitability (CEP), allowing Minakem to use an alternative natural source of raw material. This change contributes to secure the supply chain and ensures continuity of supply to its customers. This is a significant achievement for the Louvain-la-Neuve site, confirming its ability to manufacture high-quality Active Pharmaceutical Ingredients, which is essential for patient safety.
