Morepen Submits First ANDA for Sitagliptin Tablets USP in US Market

Morepen Laboratories Ltd, an Indian pharmaceutical company, has taken its first step into the US market by submitting an Abbreviated New Drug Application (ANDA) to the FDA. The application is for Sitagliptin Tablets USP in three dosage strengths: 25 mg, 50 mg, and 100 mg. This marks a significant milestone for Morepen as it enters the realm of finished dosage regulatory submissions in the US.

Sitagliptin is a Type 2 diabetes treatment belonging to the DPP-4 inhibitor class, which has seen global sales of approximately $1.604 billion in 2025 through its branded version, Januvia, marketed by Merck. The relevant US phosphate salt patent for Sitagliptin is set to expire in November 2026.

Managing Director Sanjay Suri described the submission as a capability-building milestone that brings together scientific, manufacturing, and regulatory skills needed to take an API through to a US regulatory filing. Morepen estimates a 24 to 36-month timeline from submission to potential approval and commercial supply, subject to FDA review, facility inspection, and patent clearance.