Morepen Laboratories shares jump 5% after first US ANDA filing for diabetes drug; zoom 267% in 6 months

Shares of Morepen Laboratories rose nearly 5% on Monday after the company announced that it has submitted its first abbreviated new drug application (ANDA) to the US food and drug administration (FDA) for Sitagliptin Tablets, used in the treatment of type 2 diabetes.

Extending its gains for the second consecutive session, Morepen Laboratories shares gained as much as 4.7% to hit an intraday high of ₹126.10 on the BSE. At the time of reporting, Morepen Laboratories was trading 2.5% higher at ₹123.55, with a market capitalisation of around ₹6,770 crore.

The small-cap pharma stock gained despite a sharp sell-off in the broader market, with the Sensex plunging more than 1,000 points in early trade and the Nifty slipping below the 23,000 mark amid weak global cues.

Last week, Morepen Laboratories shares touched an all-time high of ₹126.90 on September 21, 2026, rebounding nearly 280% from their 52-week low of ₹33.44, recorded on March 30. The small-cap stock has gained around 200% so far in 2026, while it has risen 267% over the past six months. The stock has added more than 16% in the past month and 157% over the past year.

What fuelled the rally in the healthcare stock?

Gurugram-based Morepen Laboratories said in an exchange filing today that it has submitted its first ANDA to the USFDA for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths.

The filing marks an expansion of the company’s active pharmaceutical ingredients (APIs) and contract development and manufacturing organisation (CDMO) capabilities into finished dosage development and regulatory submissions.

The Sitagliptin programme brings together formulation development and scale-up, analytical method development and validation, impurity control, stability studies and the manufacture of regulatory batches under GMP systems. It also includes bioequivalence strategy, coordination with contract research organisations and integration of development and study data into the regulatory dossier.

“These capabilities strengthen Morepen’s ability to support specialised CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programmes it can undertake,” the company said.

“Capability building is central to Morepen’s next phase of growth. Our first ANDA submission brings together the scientific, manufacturing and regulatory skills needed to take an API through finished dosage development to a U.S. filing,” said Sanjay Suri, Managing Director, Morepen Laboratories.

“Alongside our planned Innovation Hub and investments in advanced chemistry and technology, this milestone strengthens our ability to undertake specialised CDMO assignments and build long-term development partnerships,” Suri added.

Morepen said it intends to build on the development through customer programmes, technology transfer, co-development and licensing opportunities. The capabilities could also support product and dossier development for regulated markets across Europe and Asia, subject to jurisdiction-specific requirements.

Over time, the company plans to explore differentiated formulations, including potential US 505(b)(2) development programmes, subject to product-specific studies and regulatory requirements.

Sitagliptin is an established oral treatment for adults with Type 2 diabetes and belongs to the DPP-4 inhibitor class of medicines, commonly known as gliptins. Its innovator product, Januvia, recorded worldwide sales of approximately $1.604 billion in 2025.

Morepen currently estimates 24–36 months from submission to progress towards approval and commercial supply, subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements, and patent and exclusivity requirements.

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