Medicine
Bafiertam 95 mg capsule
Bafiertam 95 mg capsule is a prescription medicine containing Monomethyl for oral use, marketed by Banner Life Sciences, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not…
Key facts
- Active ingredient (INN)
- Monomethyl
- Brand
- Bafiertam
- Strength
- 95 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 120 capsules
- Marketing authorisation holder
- Banner Life Sciences
- Manufacturer
- Banner Life Sciences
- Origin register
- US FDA, United States
- Storage
- Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Opened Bottle Opened bottles may be stored at 20°C to 25°C (68°F to 77°F), excursions between 15°C and 30°C (59°F and 86°F) permitted. Store in original container.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 April 2020
- Identifiers
- RxCUI 2393587, 2393593DailyMed set ID a161f9d4-70f1-4097-957a-eafb35d3274fNDC 69387-001Application NDA210296
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 |
|---|---|---|---|
| 120 capsule in 1 bottle | 69387-001-01 | Banner Life Sciences | 28 April 2020 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 April 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Clinical summary
Monomethyl is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Monomethyl 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 MonomethylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BAFIERTAM prescribing information (Banner Life Sciences) · U.S. National Library of Medicine, DailyMed
Need Bafiertam 95 mg capsule 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.