Morepen Laboratories Ltd has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin tablets USP in 25 mg, 50 mg and 100 mg strengths, marking the company’s entry into integrated finished dosage development and US regulatory filings.
The submission expands Morepen’s established active pharmaceutical ingredient (API) and contract development and manufacturing organisation (CDMO) capabilities into finished dosage formulation, regulatory development and commercialisation opportunities in regulated markets.
From API to finished dosage
The Sitagliptin programme combines formulation development and scale-up with analytical method development and validation, impurity control, stability studies and manufacturing of regulatory batches under good manufacturing practice (GMP) systems.
The programme also covers bioequivalence strategy, coordination with contract research organisations and integration of development and study data into the regulatory dossier.
Morepen said these capabilities will strengthen its ability to undertake specialised CDMO assignments covering the complete development pathway from API development and finished dosage formulation to regulatory submission.
Morepen Laboratories Ltd, Managing Director Sanjay Suri, 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 US filing.”
Suri, further said that alongside the planned Innovation Hub and investments in advanced chemistry and technology, the milestone strengthens the company’s ability to undertake specialised CDMO assignments and build long-term development partnerships.”
Targeting wider regulated markets
Morepen plans to build on the platform through customer development programmes, technology transfers, co-development and licensing opportunities.
The capabilities developed through the Sitagliptin programme could also support product and dossier development for regulated markets in Europe and Asia, with submissions tailored to individual regulatory requirements.
Over time, the company intends to explore differentiated formulations, including potential US 505(b)(2) development programmes, subject to product-specific studies and regulatory requirements.
$1.6 billion innovator sales
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. The relevant US 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 market entry.
Morepen currently estimates a 24-36 month period from submission to progress towards approval and commercial supply. The timeline remains subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements and compliance with applicable patent and exclusivity requirements.
The first ANDA therefore provides Morepen with a platform to expand beyond API capabilities into higher-value finished dosage development and regulatory services, while creating opportunities to participate in customer-led product development and licensing programmes.