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Morepen Strengthens Integrated CDMO Capabilities with First U.S. ANDA Submission for Sitagliptin Tablets

Morepen Strengthens Integrated CDMO Capabilities with First U.S. ANDA Submission for Sitagliptin Tablets

Sep 28, 2026

Gurugram (Haryana) [India], September 28: Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The submission extends the Company’s established API and CDMO expertise into integrated finished dosage development and regulatory filing.

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