18. SEPTEMBER 2025
Coripharma Successfully Completes Development of Ivacaftor Tablets
Coripharma is pleased to announce the successful completion of development for Ivacaftor tablets in 75mg and 150mg strengths. The company has achieved positive results from both fed and fasted pivotal bioequivalence studies, marking a significant milestone in bringing this important cystic fibrosis treatment to the generic pharmaceutical market.
Regulatory Pathway and Timeline
The comprehensive dossier for Ivacaftor is currently being finalized and is expected to be completed within the coming weeks. Coripharma has secured a Decentralized Procedure (DCP) slot with Iceland as the Reference Member State, scheduled for December 2025.
Commitment to Regulatory Excellence
Coripharma conducted both fed and fasted bioequivalence studies for Ivacaftor in accordance with the latest recommendations outlined in the ICH M13a guidelines. This comprehensive approach ensures the highest standards of regulatory compliance and demonstrates the company's commitment to delivering therapeutically equivalent generic alternatives.
"The successful completion of Ivacaftor development represents our dedication to bringing high-quality generic medications to patients with rare diseases," said Thora Bjorg Magnusdottir, Director of R&D Operations at Coripharma. "Our adherence to the most current regulatory guidelines ensures that healthcare providers and patients can have confidence in the quality and efficacy of our products."
Partnership Opportunities
Coripharma is actively seeking partnership opportunities for the upcoming DCP submission. Pharmaceutical companies interested in collaborating on the commercialization of Ivacaftor tablets are invited to contact the company's Business Development team.
About Ivacaftor
Ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator used in the treatment of cystic fibrosis in patients with specific genetic mutations. The availability of generic versions of this medication will improve patient access to this essential treatment.