Morepen Laboratories gains CDSCO approval for Resmetirom bioequivalence studies, positioning the company for global NASH treatment market growth.
Morepen Laboratories has received approval from India’s Central Drugs Standard Control Organization (CDSCO) to conduct bioequivalence studies for Resmetirom tablets, a potential treatment for non-alcoholic steatohepatitis (NASH), the company announced today.
The shares of Morepen Laboratories Limited were trading at ₹62.36 up by ₹0.31 or 0.50 per cent on the NSE at 10 am.
The regulatory clearance allows Morepen to proceed with studies for three dosage strengths – 60mg, 80mg, and 100mg tablets. Clinical trials will follow according to approved protocols, positioning the company among the first Indian pharmaceutical firms prepared for this drug’s global launch.
Resmetirom targets NASH, a serious form of non-alcoholic fatty liver disease characterised by inflammation and liver damage that can progress to fibrosis, cirrhosis, and potentially liver cancer. The condition affects over 115 million people worldwide.
“This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market,” said Sanjay Suri, Executive Director at Morepen Laboratories.
Industry estimates project the global NASH treatment market to grow from $2.5 billion in 2024 to over $16 billion by 2032, driven by increasing disease prevalence and awareness.
Morepen, which has been operating for over 40 years, currently exports pharmaceutical products to more than 80 countries. The company manufactures APIs at FDA-approved facilities and aims to leverage its integrated capabilities from API production to finished dosage formulations for this new therapeutic opportunity.
Published on April 29, 2025
