Medicine
Rezdiffra 80 mg tablet
Rezdiffra 80 mg tablet is a prescription medicine containing Resmetirom for oral use, marketed by Madrigal Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Resmetirom
- Brand
- Rezdiffra
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets
- Marketing authorisation holder
- Madrigal Pharmaceuticals
- Manufacturer
- Madrigal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A05 Liver and bile treatments
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 March 2024
- Identifiers
- RxCUI 2677899, 2677905, 2677907 +3DailyMed set ID e67ea09f-a840-439c-86c8-f98585f978b2NDC 82576-080Application NDA217785
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, coated in 1 bottle | 82576-080-30 | Madrigal Pharmaceuticals | 14 March 2024 |
| 90 tablet, coated in 1 bottle | 82576-080-90 | Madrigal Pharmaceuticals | 14 March 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Resmetirom
Clinical summary
Resmetirom is a thyroid hormone receptor beta agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), among other approved uses. MedsAcross supplies Resmetirom for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ResmetiromFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- REZDIFFRA prescribing information (Madrigal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Rezdiffra: European public assessment report (EPAR) · European Medicines Agency
Need Rezdiffra 80 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.