By: IPP Bureau
Last updated : September 28, 2026 6:04 pm
First U.S. ANDA submitted for Sitagliptin Tablets USP in three strengths
Morepen Laboratories Limited has achieved a key milestone by filing its first Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). The submission covers Sitagliptin Tablets USP—a generic alternative used to treat Type 2 diabetes—and includes three dosage strengths: 25 mg, 50 mg, and 100 mg.
The Sitagliptin program integrates formulation scale-up, analytical method validation, impurity control, stability studies, and GMP-compliant regulatory batch manufacturing. It also encompasses bioequivalence strategies, contract research organization (CRO) management, and the compilation of study data for regulatory dossier submission.
These capabilities strengthen Morepen’s ability to support specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programs it can undertake.
Sanjay Suri, Managing Director, Morepen Laboratories Limited 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.”
Suri Further added, “Alongside our planned Innovation Hub and investments in advanced chemistry and technology, this milestone strengthens our ability to undertake specialized CDMO assignments and build long-term development partnerships.”
Morepen intends to build on this foundation through customer development programs, technology transfer, co-development and licensing opportunities. Over time, the company aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programs, subject to product-specific studies and regulatory requirements.
Sitagliptin is an established oral treatment for adults with Type 2 diabetes, belonging to the DPP- 4 inhibitor class, commonly known as gliptins. Its innovator product, Januvia, recorded worldwide sales of approximately US$1.604 billion in 2025.1 The relevant U.S. phosphate salt patent is scheduled to expire in November 2026, with associated paediatric exclusivity extending to May 2027; certain manufacturers have separate arrangements permitting earlier entry.
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 applicable patent and exclusivity requirements.