By: IPP Bureau
Last updated : November 10, 2026 11:16 am
Desloratadine Tablets launch complements Morepen’s broader API, R&D and CDMO growth strategy
Morepen Laboratories Limited has officially entered the U.S. prescription generics sector by debuting its inaugural prescription (Rx) generic drug, Desloratadine Tablets USP (5 mg). The company is distributing the new product in 100-count and 500-count packaging units through Morepen Bio Inc., its wholly owned U.S. subsidiary.
Morepen has been supplying Desloratadine API to the U.S. market for many years. Building on this established API position, the latest launch extends the company's participation further along the pharmaceutical value chain into finished-dosage medicines and U.S. distribution.
Sanjay Suri, Managing Director, Morepen Laboratories Limited, said, “Our long-standing API relationships in regulated markets provide a strong foundation for Morepen's next phase of growth. Alongside our expanding CDMO business, we are selectively extending our capabilities into finished-dosage development and U.S. distribution. This reflects our strategy to build a more integrated, R&D-led pharmaceutical business with sustainable, long-term growth opportunities.”
The prescription generics expansion follows Morepen's earlier U.S. OTC product introductions. Separately, the company has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. FDA for Sitagliptin Phosphate Tablets USP, 25 mg, 50 mg and 100 mg. This milestone demonstrates Morepen's growing capabilities in formulation development, analytical science and regulatory filings. The application is currently under regulatory review.
Looking ahead, Morepen intends to pursue additional U.S. prescription generic filings and distribution opportunities where its established API and pharmaceutical R&D capabilities provide a competitive advantage. The company may also evaluate selected opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements and market conditions.