FDA — authorised 22 April 2025
- Application: ANDA218444
- Marketing authorisation holder: RICONPHARMA LLC
- Local brand name: SIPONIMOD
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 BAF312 in United States
FDA authorised BAF312 on 22 April 2025
Marketing authorisations
FDA — authorised 6 March 2026
- Application: ANDA218459
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: SIPONIMOD
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA218228
- Marketing authorisation holder: CIPLA LTD
- Local brand name: SIPONIMOD
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA218393
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: SIPONIMOD
- Indication: TABLET
- Status: approved
BAF312 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is BAF312 approved in United States?
Yes. FDA authorised it on 22 April 2025; FDA authorised it on 6 March 2026; FDA has authorised it.
Who is the marketing authorisation holder for BAF312 in United States?
RICONPHARMA LLC holds the US marketing authorisation.