Morepen Laboratories Limited has received clearance from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct Bioequivalence (BE) studies for Resmetirom 60 mg, 80 mg, and 100 mg tablets.

• This clearance is for the protocol submitted and will be followed by clinical trials as per approved protocols.
• Resmetirom is a highly promising therapy under development for non-alcoholic steatohepatitis (NASH), a serious form of non-alcoholic fatty liver disease (NAFLD).
• Sanjay Suri, Executive Director, stated, "This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market... We are proud to be one of the first few Indian companies gearing up to launch the finished formulation of Resmetirom. Our end-to-end integration – from APIs to finished dosage – gives us a unique edge in speed, quality, and scalability."
• Morepen is strategically positioned to serve both domestic and international markets and is also evaluating out-licencing opportunities.
• The global NASH treatment market is projected to grow from USD 2.5 billion in 2024 to over USD 16 billion by 2032.
• Morepen highlighted its global footprint, exporting to over 80 countries including regulated markets, and its USFDA, EU-GMP, and WHO-GMP compliant API facilities.