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In a major advancement for the Indian pharmaceutical industry, Morepen Laboratories Limited has announced plans to launch Resmetirom, a highly anticipated drug for the treatment of fatty liver disease, specifically non-alcoholic steatohepatitis (NASH). This announcement comes after receiving critical regulatory clearance from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to commence Bioequivalence (BE) studies for Resmetirom 60 mg, 80 mg, and 100 mg tablets.

This regulatory milestone marks a significant step forward for Morepen Laboratories, as it readies itself for clinical trials under approved protocols. The move positions Morepen among the first Indian pharmaceutical companies to introduce Resmetirom globally, emphasizing its leadership and innovation in hepatology — a relatively underexplored therapeutic domain within Indian pharma.

Understanding Resmetirom and Its Importance

Resmetirom is a novel therapeutic agent under development for NASH, a severe form of non-alcoholic fatty liver disease (NAFLD). NASH is characterized by liver inflammation, fat accumulation, and fibrosis, which can escalate to cirrhosis and even liver cancer if untreated. Closely linked to obesity, metabolic syndrome, and type 2 diabetes, NASH is often dubbed a silent killer due to its asymptomatic nature in early stages.

The urgency to address NASH has grown, given that over 115 million people worldwide suffer from this progressive liver disease. Industry estimates project the global NASH treatment market to surge from USD 2.5 billion in 2024 to over USD 16 billion by 2032, driven by increasing disease prevalence, heightened clinical awareness, and emerging regulatory approvals.

In this context, Resmetirom is hailed as a breakthrough therapy due to its mechanism of action targeting liver-specific thyroid hormone receptors (THR-β), leading to reduced liver fat without adverse effects on heart rate or bone density — a common concern with older drug classes.

Morepen’s Strategic Positioning and Future Plans

Sanjay Suri, Executive Director of Morepen Laboratories, emphasized,

“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.”

Morepen’s integrated business model — from Active Pharmaceutical Ingredients (APIs) to finished dosages — gives it an edge in speed, quality, and scalability. Such end-to-end capabilities mean faster development timelines, better regulatory compliance, and competitive cost structures, which are crucial in capturing domestic and global markets effectively.

The company also indicated its intent to explore out-licensing opportunities with potential marketing partners, broadening the reach and commercial success of Resmetirom.

Global Reach and Regulatory Excellence

Morepen’s confidence stems from its established global footprint. The company exports APIs and formulations to over 80 countries, including highly regulated markets like the United States, Europe, and Japan. Its manufacturing facilities meet the stringent standards of USFDA, EU-GMP, and WHO-GMP certifications.

This strong compliance record, combined with early entry into the Resmetirom market, enhances Morepen’s positioning as a trusted player not only in India but also on the international stage. The company's ability to leverage global trends, manufacture at scale, and maintain exceptional quality standards makes it a compelling investment opportunity in the specialty and chronic care segments.

A Look at Morepen Laboratories' Legacy

With a rich history spanning over four decades, Morepen Laboratories has firmly established itself as a leading force in India's pharmaceutical sector. Key highlights of the company include:

• India’s #1 exporter of APIs for six essential molecules.

• Targeting a ₹1,000 crore formulation business scale-up.

• Leadership in medical devices with over 14 million glucometer installations.

• A robust pipeline of future-ready products aligned with global healthcare trends.

These strategic pillars, combined with forward-looking management and state-of-the-art manufacturing capabilities, reflect Morepen's mission to bolster India’s reputation as the pharmacy of the world.

Broader Implications for the Indian Pharma Sector

Morepen’s move to bring Resmetirom to market underscores a critical shift within the Indian pharmaceutical sector — from being primarily a manufacturer of generic medicines to pioneering innovation and driving specialty pharma growth.

This initiative also reflects India's rising potential to address non-communicable diseases (NCDs) such as NASH, which are becoming major public health challenges not just domestically but globally. By entering high-value, unmet medical need spaces, companies like Morepen are not just creating business opportunities but also contributing meaningfully to global healthcare solutions.

Conclusion

In conclusion, the launch of Resmetirom marks a new chapter for Morepen Laboratories and for Indian pharma at large. With regulatory clearances secured, a strong manufacturing base, and a keen focus on innovation, Morepen is well-poised to make a significant impact in the evolving treatment landscape for fatty liver disease.

Investors, healthcare professionals, and patients alike can expect exciting developments as Morepen accelerates its journey towards making Resmetirom a global success story.

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