Resmetirom bulk supplier for pharma manufacturers

Resmetirom 80 mg ,100 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 80 mg ,100 mg

Reference Brands: Rezdiffra (USA)

Resmetirom (Rezdiffra, Madrigal Pharmaceuticals) is a once-daily tablet for MASH (metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis but no cirrhosis. The US FDA approved it in March 2024 as the first medicine for this condition. The dose is 80 mg, or 100 mg for people weighing 100 kg or more.

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Product Description:

Resmetirom is a liver-directed, selective thyroid hormone receptor beta agonist. Hepatic THR-beta drives lipid metabolism, so selective agonism reduces intrahepatic fat without the cardiac and bone effects that come from THR-alpha activity. It was the first drug approved specifically for metabolic dysfunction-associated steatohepatitis with moderate to advanced fibrosis, on accelerated approval against histological endpoints.

Dosing is by body weight rather than titration, and the drug interaction profile is the practical constraint: it is a CYP2C8 substrate, and strong CYP2C8 inhibition is contraindicated. Statin co-prescription needs attention because many of these patients are already on one and exposure can rise.

Sourcing notes. Originator, on patent, no generic. Approval status differs markedly between regions and is still moving, so confirm the position in the destination market rather than assuming it follows the US.

How Resmetirom is supplied today, and licensing ahead of patent expiry

Resmetirom is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Resmetirom, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Resmetirom is used for the treatment of adults with non-cirrhotic metabolic dysfunction–associated steatohepatitis (MASH/NASH) with moderate to advanced liver fibrosis.

Resmetirom is a small-molecule, synthetic thyroid hormone receptor-beta selective agonist designed to target liver tissue.

The trade name of resmetirom is Rezdiffra.

Resmetirom (Rezdiffra) is manufactured and marketed by Madrigal Pharmaceuticals.

The generic name of Resmetirom is resmetirom.

The brand name of Resmetirom is Rezdiffra.

Resmetirom (Rezdiffra) is manufactured for Madrigal Pharmaceuticals, United States, through approved pharmaceutical manufacturing facilities compliant with FDA regulations.

Rezdiffra (Resmetirom) is developed and sold by Madrigal Pharmaceuticals. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.