Morepen Laboratories Limited has announced its entry into the US prescription generics market with the launch of its first prescription generic product, Desloratadine Tablets USP, 5 mg, in 100-count and 500-count packs.

The product will be distributed in the US market through the company's wholly owned US subsidiary, Morepen Bio Inc.

The launch builds on Morepen's established presence in the US market as a supplier of Desloratadine active pharmaceutical ingredients (API) for several years. With this move, the company is expanding its presence across the pharmaceutical value chain, moving from API supplies into finished-dosage formulations and distribution in the US.

Sanjay Suri, Managing Director of Morepen Laboratories, said the company's long-standing API relationships in regulated markets provide a strong foundation for its next phase of growth. He added that the company is selectively expanding into finished-dosage development and US distribution alongside its growing Contract Development and Manufacturing Organisation (CDMO) business.

The entry into prescription generics follows Morepen's earlier launch of over-the-counter (OTC) products in the US market.

Separately, the company has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin Phosphate Tablets USP in strengths of 25 mg, 50 mg and 100 mg. The application is currently under regulatory review.

Morepen said the submission reflects its growing capabilities in formulation development, analytical science and regulatory filings.

Going forward, the company plans to pursue additional US prescription generic filings and distribution opportunities, leveraging its established API business and pharmaceutical research and development capabilities. It may also explore opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements and market conditions.