Morepen Laboratories receives CDSCO clearance for bioequivalence studies on Resmetirom

Morepen Laboratories 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 as per the submitted protocol. This clearance will be followed by clinical trials under approved protocols.

Resmetirom is under development for the treatment of non-alcoholic steatohepatitis (NASH), a form of non-alcoholic fatty liver disease (NAFLD) that can lead to inflammation, liver damage, and fat accumulation. If left untreated, it can progress to scarring (fibrosis), cirrhosis, and liver cancer. It is often associated with obesity, metabolic syndrome, and type 2 diabetes.

“This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market,” said Sanjay Suri, Executive Director, Morepen Laboratories. “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.”

As one of the reportedly first Indian companies entering this therapeutic area, Morepen Laboratories is preparing to serve both domestic and international markets. The company is evaluating out-licensing opportunities with potential marketing partners.

NASH is a progressive liver disease affecting over 115 million people globally. Industry estimates project the global NASH treatment market to grow from USD 2.5 billion in 2024 to over USD 16 billion by 2032, driven by prevalence rates, clinical awareness, and regulatory approvals.

Morepen Laboratories exports APIs and formulations to over 80 countries, including regulated markets such as the United States, Europe, and Japan. The company’s API manufacturing facilities are compliant with USFDA, EU-GMP, and WHO-GMP standards.

Morepen’s position in Resmetirom development, combined with its scale, integration, and regulatory compliance, supports its business strategy in the specialty and chronic care segments. The company’s capabilities in manufacturing and regulatory adherence enable it to act as a partner for global innovators and marketing firms.