Amarin Targets Novasep as Fourth Supplier of Vascepa API
Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.
Amarin, a biopharmaceutical company, has filed a supplemental new drug application with FDA seeking approval to make Novasep Group, through its subsidiary Finorga, as an additional supplier of icosapent ethyl, the API in Vaseepa Amarin’s omega-3-fatty acid product supplier. Novasep is part of the previously disclosed Slanmhor consortium with which Amarin announced a global supply agreement in 2012.
Novasep, a provider of purification technologies and API manufacturing, is building a chromatography plant using its proprietary chromatography technologies to produce API on behalf of the Slanmhor consortium and Amarin. Amarin anticipates the Novasep facility, located in Mourenx, France, to be qualified and operational for manufacturing in 2014.
Source: Amarin
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
