Morepen Laboratories Limited (MOREPENLAB)
Press Release
Morepen Laboratories submitted its first U.S. ANDA for Sitagliptin Tablets in 25 mg, 50 mg, and 100 mg strengths, marking a key milestone in integrated CDMO capabilities. The submission enhances formulation, bioequivalence, and regulatory dossier expertise, supporting specialized CDMO projects in regulated markets. The ANDA was filed on September 25, 2026, with approval expected in 24-36 months, subject to FDA review and patent conditions. This advances Morepen's API-to-finished dosage development and regulatory filing capabilities.
Source: Original filing PDF
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