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Morepen Laboratories Launches First Prescription Generic Product in the US

Morepen Laboratories Launches First Prescription Generic Product in the US

Morepen Laboratories has launched its first prescription (Rx) generic product, Desloratadine Tablets USP, 5 mg, in the US market through its wholly owned US subsidiary, Morepen Bio. The product is being introduced in 100-count and 500-count packs for distribution in the United States.

Desloratadine is a second-generation antihistamine administered once daily for the treatment of seasonal and perennial allergic rhinitis. According to the US Centers for Disease Control and Prevention (CDC), 25.2 percent of adults were diagnosed with seasonal allergies in 2024. The US allergic rhinitis market was valued at approximately USD 5.65 billion in 2025 and is projected to grow at an annual rate of around 4.2 percent through 2033.

Morepen has been supplying desloratadine Active Pharmaceutical Ingredients (APIs) to US customers for several years. The product launch expands the company's presence in the US pharmaceutical market by extending its operations from API supply to finished-dosage distribution, adding further value to its existing business.

Sanjay Suri, Managing Director of Morepen Laboratories, said the company's established API relationships in regulated markets provide a foundation for expanding its business. He added that the company is selectively extending its capabilities into finished-dosage development and US distribution alongside its growing contract development and manufacturing organisation (CDMO) business.

The prescription generic launch follows Morepen's earlier introduction 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 25 mg, 50 mg and 100 mg strengths. The application is currently under regulatory review.

The ANDA submission marks an expansion of Morepen's capabilities in formulation development, analytical science and regulatory filings. Going forward, the company plans to pursue additional US prescription generic filings and distribution opportunities, focusing on products that align with its existing API and pharmaceutical research and development capabilities.

More news about: market | Published by News Bureau | November - 10 - 2026

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