Medicine
Sirturo 100 mg tablet
Sirturo 100 mg tablet is a prescription medicine containing Bedaquiline for oral use, marketed by Janssen Products, 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 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to…
Key facts
- Active ingredient (INN)
- Bedaquiline
- Brand
- Sirturo
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 188 tablets
- Marketing authorisation holder
- Janssen Products
- Manufacturer
- Janssen Products
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store at 25°C (77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Store in original container. Protect from light and moisture. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J04AK05 Bedaquiline
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 December 2012
- Identifiers
- RxCUI 1364509, 1364515, 2373939 +1DailyMed set ID 1534c9ae-4948-4cf4-9f66-222a99db6d0eNDC 59676-701Application NDA204384
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 |
|---|---|---|---|
| 188 tablet in 1 bottle | 59676-701-01 | Janssen Products | 28 December 2012 |
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 Bedaquiline
Clinical summary
Bedaquiline is a diarylquinoline antimycobacterial indicated as part of combination therapy in the treatment of adult, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Bedaquiline 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 BedaquilineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SIRTURO prescribing information (Janssen Products) · U.S. National Library of Medicine, DailyMed
- Sirturo: European public assessment report (EPAR) · European Medicines Agency
Need Sirturo 100 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.