The manufacturer of the specific Resiliva product is Everest Pharmaceuticals Ltd.
This should be distinguished from the documented development history of resmetirom.
Resmetirom development
Resmetirom was originally developed by VIA Pharmaceuticals under a license from F. Hoffmann-La Roche. Madrigal Pharmaceuticals acquired VIA’s relevant rights and obligations in 2011 and subsequently continued development of MGL-3196.
Madrigal ultimately developed resmetirom through clinical development and regulatory submission. FDA granted approval of Rezdiffra to Madrigal Pharmaceuticals in March 2024.
Reference product
Rezdiffra is the established reference brand associated with resmetirom in the United States and European Union.
The EMA lists Madrigal Pharmaceuticals EU Limited as the marketing authorization holder for Rezdiffra in the EU.
Important distinctions
- Original developer: historical developer of the molecule.
- Current developer/reference-product company: Madrigal Pharmaceuticals.
- Manufacturer: company manufacturing a particular medicinal product.
- Marketing authorization holder: entity legally responsible for a specific authorization.
- Distributor: entity involved in distribution.
- Supplier: entity supplying a product through a commercial channel.
These roles should not be treated as interchangeable.