Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for sitagliptin USP tablets in three dosages: 25 mg, 50 mg, and 100 mg. This move marks the company's entry into the U.S. market for finished dosage form development and regulatory reporting.
This submission expands Morepen's existing capabilities in Active Pharmaceutical Ingredients (API) and Contract Development and Manufacturing Organization (CDMO), including formulation development, bioequivalence, analytical validation, stability studies, and manufacturing processes for regulatory batches.
Sitagliptin is a DPP-4 inhibitor used to treat type 2 diabetes. The innovative product, Januvia, recorded global sales of $1.6 billion in 2025, according to Merck's 2025 annual report.
Management Statements
Sanjay Suri, Managing Director of Morepen Laboratories, noted that the first ANDA submission integrates the scientific, manufacturing, and regulatory expertise required to advance an API through finished dosage form development for submission in the US. Suri also added that alongside the planned Innovation Center and investments in advanced chemistry and technology, this strengthens the company's ability to undertake specialized CDMO assignments and build long-term development partnerships.
Morepen forecasts that from the date of submission to approval and commencement of commercial supply will take between 24 and 36 months, contingent upon FDA review, appropriate site inspections, and compliance with patent and exclusivity requirements.
The relevant patent for sitagliptin phosphate salt in the US expires in November 2026, and parenteral exclusivity is extended until May 2027. Morepen reported that some manufacturers have separate agreements allowing them to enter the market earlier.
The company emphasized that this program enhances its potential in executing specialized CDMO assignments, covering API development, finished dosage form formulation, and regulatory filings. It plans to develop this competency through customer development programs, technology transfer, joint development, and licensing opportunities.
ANDA number 221758 was filed on September 25, 2026. Morepen clarified that this filing alone does not signify acceptance by the FDA for substantive review, product approval, or authorization for commercial supply in the US.