Morepen Enters U.S. Prescription Generics Market With The Launch Of Its Desloratadine Tablets, Complementing Broader API, R&D And CDMO Growth Strategy

New Delhi, Delhi, India: Morepen Laboratories Limited announced the launch of its first prescription (Rx) generic product, Desloratadine Tablets USP, 5 mg, in 100-count and 500-count packs, for distribution in the U.S. market. The initiative is being undertaken through its wholly owned U.S. arm, Morepen Bio Inc.

Desloratadine is a once-daily, second-generation antihistamine for seasonal and perennial allergic rhinitis. The U.S. CDC reported that 25.2% of adults were diagnosed with seasonal allergies in 2024. The broader U.S. allergic rhinitis market was valued at approximately USD 5.65 billion in 2025 and is projected to grow about 4.2% annually through 2033.

Morepen has been supplying Desloratadine API to U.S. customers for years. This launch builds on this position, extending Morepen from API supply into finished-dosage distribution with enhanced value addition.

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.

About Morepen Laboratories Limited

Morepen Laboratories Limited is a publicly listed Indian pharmaceutical and healthcare company with businesses spanning active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, formulations and healthcare products. The company serves customers across domestic and international markets.