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Morepen Laboratories has got clearance from Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to conduct Bioequivalence (BE) studies for Resmetirom 60 mg, 80 mg and 100 mg tablets as per the protocol submitted. This 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) characterized by inflammation, liver damage, and fat accumulation in the liver, potentially leading to scarring (fibrosis), cirrhosis, and even liver cancer. It is often associated with obesity, metabolic syndrome, and type 2 diabetes, and while it can be a silent disease in the early stages, it can progress to severe liver damage if left untreated.
As one of the first Indian companies to foray into this therapeutic area, Morepen is strategically positioned to serve both domestic and international markets and is also evaluating out-licencing opportunities with potential marketing partners.
Morepen Laboratories announced the launch of four new products—Ticapen, UdoFix, LycoMore, Acifix in the month of April 2025 to cater the domestic market in addition to Empamore launched last month continuing.
This strategic expansion reinforces Morepen's commitment to scaling its finished dosages business while continuing to invest in cutting-edge R&D that powers a robust pipeline of differentiated, high quality medicines. Importantly, all APIs used in these products are manufactured in-house by Morepen at its world-class, USFDA-approved plants, ensuring consistent quality and supply chain control.