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Resiliva 80 mg & 100 mg (Resmetirom)

The manufacturer of the specific Resiliva product is Everest Pharmaceuticals Ltd.

This question should be separated from the documented development history of resmetirom.

Historical development

Resmetirom was initially developed by VIA Pharmaceuticals under license from F. Hoffmann-La Roche. Madrigal Pharmaceuticals acquired VIA’s rights and obligations relating to MGL-3196 in 2011 and continued development.

Reference product

Rezdiffra is the approved reference product containing resmetirom. FDA records Madrigal Pharmaceuticals as the company associated with the U.S. NDA, while the EMA identifies Madrigal Pharmaceuticals EU Limited as the EU marketing authorization holder.

Manufacturer versus developer

The original developer of a medicine does not necessarily manufacture every later product containing the same active ingredient.

For Resiliva, the following remain Everest Pharmaceuticals Ltd.

  • Specific manufacturer
  • Manufacturing site
  • Brand owner
  • Marketing authorization holder
  • Distributor
  • Supplier
  • GMP certification applicable to the product

Official company information

Madrigal’s corporate resources describe its development and commercialization of resmetirom. This does not by itself establish that Madrigal manufactures Resiliva.