Mumbai: Morepen Laboratories Ltd announced on 28 September 2026, the submission of its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for Sitagliptin Tablets USP. The submission includes 25 mg, 50 mg, and 100 mg strengths of the tablets.
Expanding CDMO Capabilities
This submission enhances Morepen's capabilities in integrated finished dosage development and regulatory filing. It supports specialised Contract Development and Manufacturing Organisation (CDMO) assignments, covering API development, finished dosage formulation, and regulatory submissions.
Sitagliptin Programme Details
The Sitagliptin programme incorporates formulation development, scale-up, analytical method development, and validation. It also includes impurity control, stability studies, and the manufacture of regulatory batches under Good Manufacturing Practices (GMP) systems.
Management Statement
Sanjay Suri, Managing Director, Morepen Laboratories, said the first ANDA submission integrates the scientific, manufacturing, and regulatory skills required to take an API through finished dosage development to a U.S. filing. Suri added that the milestone strengthens the company's ability to undertake specialised CDMO assignments and build long-term development partnerships.
Market Opportunity
Sitagliptin is used to treat Type 2 diabetes. Its innovator product, Januvia, recorded worldwide sales of approximately ₹13,380 crore in 2025. Morepen expects 24–36 months for approval and commercial supply, subject to FDA review and patent requirements.
Future Plans
Morepen plans to build on this foundation through customer development programmes, technology transfer, co-development, and licensing opportunities. The company aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programmes.
Patent Expiry
The relevant U.S. sitagliptin phosphate salt patent is scheduled to expire on 24 November 2026, with paediatric exclusivity extending to 24 May 2027. Some manufacturers have separate arrangements for earlier entry.
Disclaimer: This story is based on company exchange filings and is for informational purposes only. Investors should evaluate risks before making decisions.
