Archive · 14 Aug 2025
Shilpa Medicare's NorUDCA Gets First NAFLD Approval
Shilpa Medicare has created a new medicine called NorUDCA to help people with a liver problem called NAFLD.
NAFLD happens when too much fat builds up in the liver.
This new medicine is the first of its kind to be approved in the world.
It works by helping with inflammation and bile acid regulation in the liver.
Many people worldwide have NAFLD, so this new medicine is very important.
Clinical trials showed it worked well and was safe for patients.
The company plans to start selling it in India and then in other countries.
Shilpa Medicare received world's first regulatory approval for NorUDCA to treat NAFLD.
NorUDCA is a novel therapy that targets Non-Alcoholic Fatty Liver Disease (NAFLD).
NAFLD affects 1 in 4 people globally, including 188 million in India.
The therapy combines anti-inflammatory benefits with enhanced bile acid regulation.
Clinical trials showed NorUDCA's efficacy and safety with no major adverse events.
- Who
- Shilpa Medicare Limited.
- What
- Approval of NorUDCA, a new therapy for NAFLD.
- When
- Approval date not specified, but recent.
- Where
- India (approval by CDSCO), with global implications.
- Why
- To offer a treatment for NAFLD, a disease affecting millions globally.
- Drug Name
- NorUDCA
- Disease Targeted
- NAFLD (Non-Alcoholic Fatty Liver Disease)
- Approval Granted By
- India's CDSCO
- Company
- Shilpa Medicare Limited
- Mechanism
- Dual-action: anti-inflammatory and bile acid regulation
- Global Prevalence of NAFLD
- 1 in 4 people
- Patients in India
- 188 million