
Morepen Labs Launches First US Prescription Generic: Desloratadine Tablets
Morepen Laboratories Limited has announced the launch of its first prescription (Rx) generic product, Desloratadine Tablets USP, 5 mg, in the U.S. market through its U.S. subsidiary, Morepen Bio Inc. This move builds upon the company's established strength in supplying Desloratadine API to the U.S. for years. The launch signifies Morepen's strategic expansion further along the pharmaceutical value chain into finished-dosage medicines and U.S. distribution. The company has also submitted its first Abbreviated New Drug Application (ANDA) for Sitagliptin Phosphate Tablets USP to the U.S. FDA, which is currently under review. Morepen plans to pursue further U.S. prescription generic filings and distribution opportunities, leveraging its API and R&D capabilities, and may explore high-potency APIs and oncology. This expansion complements their existing CDMO business and OTC product introductions.
Key Highlights
- Morepen launches first US prescription generic, Desloratadine Tablets.
- Expansion into finished-dosage medicines via US subsidiary Morepen Bio Inc.
- First ANDA for Sitagliptin Phosphate Tablets submitted to US FDA.
- Strategy to build integrated, R&D-led pharmaceutical business.
- Leveraging established API strengths for further growth in regulated markets.
Price Impact
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