Morepen Laboratories Limited announced the launch of its first prescription (Rx) generic product for the U.S. market through a regulatory filing submitted to the National Stock Exchange of India Ltd. and BSE Limited.
The company launched Desloratadine Tablets USP, 5 mg, available in 100-count and 500-count packs, for distribution in the U.S. market. This initiative is being undertaken through its wholly owned U.S. arm, Morepen Bio Inc.
This launch represents an extension of the company's business further along the pharmaceutical value chain into finished-dosage medicines and U.S. distribution, building on its established position as a supplier of Desloratadine API to the U.S. market for many years.
According to Sanjay Suri, Managing Director of Morepen Laboratories Limited, this move reflects the company's strategy to build a more integrated, R&D-led pharmaceutical business with sustainable, long-term growth opportunities. The expansion leverages the company's long-standing API relationships in regulated markets.
In a separate development, 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 application is currently under regulatory review and demonstrates Morepen's growing capabilities in formulation development, analytical science and regulatory filings.
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.
This prescription generics expansion follows Morepen's earlier U.S. OTC product introductions.