Morepen launches first US prescription generic, eyes further filings

Indian pharmaceutical and healthcare company Morepen Laboratories on Monday announced that it has launched its first prescription generic product, Desloratadine Tablets USP, 5 mg, in the US market, marking its entry into the country's prescription generics segment.

Morepen said in an exchange filing that it is introducing the product in 100-count and 500-count packs through Morepen Bio Inc., the company's wholly owned US subsidiary.

While Morepen has supplied Desloratadine active pharmaceutical ingredient (API) to the US market for several years, the latest launch extends the company’s presence further up the pharmaceutical value chain into finished-dosage medicines and distribution in the US.

Morepen Laboratories Managing Director Sanjay Suri 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 launch follows the company's earlier introduction of over-the-counter (OTC) products in the US market. Morepen has also submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin Phosphate Tablets in strengths of 25 mg, 50 mg and 100 mg. The application is currently under regulatory review.

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