Louvain-la-Neuve, 14th January 2025 Minakem has been manufacturing the Fulvestrant Active Pharmaceutical Ingredient (API), used to treat certain types of breast cancer, for more than 10 years. The original process (generation 1) required a significant quantity of solvents to purify the API to achieve the high quality necessary for injectable applications.
Over the last 5 years, Minakem has developed an innovative generation 2 (Gen2) process and applied for a Certificate of suitability to the Monographs of the European Pharmacopoeia (CEP), which was approved in November 2024 by the EDQM.
This new API process enables the production of significantly improved quality earlier in the process, eliminating the need for the final purification step. The original purification step was highly solvent-intensive, with the solvents being burnt after use. The reduction in solvent consumption not only improves sustainability but also provides an economic advantage by enhancing the competitiveness of Minakem, key in the generics industry.
Ecovamed, a company based in Paris, France, has estimated the carbon footprint reduction between the old and new processes to exceed 3.4 tonnes of CO2 equivalent per kilogram of Fulvestrant.
This business case demonstrates how innovation can combine cost reduction with a significantly improved carbon footprint. Most importantly, the quality of Fulvestrant remains high, a critical requirement for injectable drugs.
About Minakem Louvain-la-Neuve’s Expertise
Minakem Louvain-la-Neuve has been manufacturing Highly Potent Active Pharmaceutical Ingredients (HPAPIs) for over 20 years. The site has long-standing expertise in purification (by HPLC when needed) and the production of vinca derivatives (complex flower extracts derived from natural feedstock) and their transformation into APIs. Additionally, the site has experience in lyophilising APIs for injectable applications, particularly in oncology treatments.
The site also manufactures controlled substances, including Remifentanil API.
Strategically located in the heart of Europe, near Brussels, the site exports 100% of its production globally.
About Minakem
Minakem has 4 different API manufacturing sites, which are all approved by the US FDA and local health agencies
Minakem is a member of the MINAFIN Group and as such has access to all technologies, resources and capabilities to respond to its clients’ needs, especially with Minascent technologies (Leuna, Germany) and Pennakem (Memphis, TN, USA)
About Ecovamed
Ecovamed is an innovative company created in 2020 that supports the healthcare sector to improve its sustainability. With its enhanced Life Cycle Assessment process, Ecovamed allows the healthcare industry and the chemical and biotechnology industries to assess the environmental footprint of their products at a lower cost and with higher quality, which is the first step before setting greenhouse gas emission reduction plans and reducing other environmental impacts. For more information, contact us at contact@ecovamed.com.
Press Contact
Véronique Lutun – Communications Manager
veronique.lutun@minakem.com
Minakem High Potent
8, rue Fond Jean Pâques
BE-1435 Mont-Saint-Guibert
Belgium