The approval reinforces Shilpa Medicare’s commitment to addressing unmet medical needs in hepatology through innovation and evidence‐based solutions.
This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD.
NorUDCA is the first‐in‐class treatment for non‐alcoholic fatty liver disease (NAFLD) in India, addressing a significant unmet medical need.
NAFLD is currently the most prevalent liver condition globally, affecting about 25% of the world’s population (approximately 1.2 billion people) and impacting an estimated 188 million individuals in India alone.
If not managed early, NAFLD may progress to non‐alcoholic steatohepatitis (NASH) and severe liver complications, underscoring the urgent necessity for effective therapy.
These results collectively demonstrate a significant improvement in both liver structure and function, confirming NorUDCA’s superior efficacy compared to placebo in NAFLD.
Vishnukant Bhutada, managing director, Shilpa Medicare, said: "We are delighted to receive historic approval for NorUDCA, India’s first‐in‐class therapy for NAFLD—making Shilpa the first company globally to obtain approval for NorUDCA in this indication.
This milestone is a moment of immense pride for Shilpa and the nation, as we now pioneer the launch of its finished dosage form. This breakthrough exemplifies Shilpa’s unwavering dedication to innovation and accessible healthcare to millions battling liver disease in India and beyond.
We are excited to introduce NorUDCA tabletsin India immediately, while advancing global regulatory efforts to bring this vital therapy to patients internationally.”
Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.
The company's consolidated net profit fell 40.77% to Rs 14.51 crore, while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24.
The scrip had advanced 1.46% to end at Rs 831.80 on the BSE on Friday.