CDSCO
- Status: likely_approved
🇮🇳 Pradaxa in India
Pradaxa (dabigatran etexilate) regulatory status in India.
Marketing authorisation
Pradaxa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in India
Frequently asked questions
Is Pradaxa approved in India?
Yes. CDSCO has authorised it.
Who is the marketing authorisation holder for Pradaxa in India?
Generic (originally Boehringer Ingelheim) is the originator. The local marketing authorisation holder may differ — check the official source linked above.