Shilpa Medicare has achieved a significant milestone in hepatology by receiving approval for NorUDCA, the world's first approved treatment specifically for non-alcoholic fatty liver disease (NAFLD). This historic approval makes Shilpa the first company globally to obtain regulatory clearance for NorUDCA in this indication, positioning India at the forefront of NAFLD treatment innovation.
Addressing a Global Health Crisis
NAFLD represents the most prevalent liver condition worldwide, affecting approximately 25% of the global population, which translates to about 1.2 billion people. In India alone, an estimated 188 million individuals are impacted by this condition. The disease's progression potential adds urgency to treatment needs, as NAFLD can advance to non-alcoholic steatohepatitis (NASH) and severe liver complications if not managed early.
Clinical Efficacy Demonstrated
Clinical trial results collectively demonstrate significant improvement in both liver structure and function, confirming NorUDCA's superior efficacy compared to placebo in NAFLD patients. These findings support the drug's classification as a first-in-class treatment, addressing a significant unmet medical need in hepatology.
Company Leadership Perspective
Vishnukant Bhutada, managing director of Shilpa Medicare, expressed the significance of this achievement: "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."
Global Expansion Plans
The company plans to introduce NorUDCA tablets in India immediately while simultaneously advancing global regulatory efforts to bring this therapy to patients internationally. This breakthrough exemplifies Shilpa's commitment to innovation and accessible healthcare for millions battling liver disease in India and beyond.
Company Background
Shilpa Medicare operates as a manufacturer of active pharmaceutical ingredients (APIs), formulations, and development services. The company began operations as an API manufacturer in 1987 at Raichur, Karnataka, India. The approval reinforces Shilpa Medicare's commitment to addressing unmet medical needs in hepatology through innovation and evidence-based solutions.
