Morepen Labs Launches Desloratadine in US, Files First ANDA for Sitagliptin
New Delhi: Morepen Laboratories Limited 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 Inc.
The product will be available in 100-count and 500-count packs, marking the company's expansion from supplying active pharmaceutical ingredients (APIs) to participating in finished-dosage manufacturing and distribution in the US prescription generics market.
Morepen has been supplying Desloratadine API to the US market for several years. Building on its established position in the API segment, the latest launch represents a further step in expanding its presence across the pharmaceutical value chain.
Sanjay Suri, Managing Director of 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 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 milestone highlights Morepen's expanding capabilities in formulation development, analytical science and regulatory filings. The application is currently under regulatory review.
Looking ahead, Morepen intends to pursue additional US prescription generic filings and distribution opportunities where its established API and pharmaceutical research and development capabilities offer 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.
The latest launch reflects Morepen's strategy to build a more integrated pharmaceutical business by expanding beyond API supplies into finished formulations, CDMO services and international distribution.
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.
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