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.SmarketThe initiative is being undertaken through its wholly owned U.Sarm, Morepen Bio Inc.
Desloratadine is a once-daily, second-generation antihistamine for seasonal and perennial allergic rhinitisThe U.SCDC reported that 25.2% of adults were diagnosed with seasonal allergies in 2024The broader U.Sallergic 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.Scustomers for yearsThis 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 growthAlongside our expanding CDMO business, we are selectively extending our capabilities into finished-dosage development and U.SdistributionThis 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.SOTC product introductionsSeparately, the company has submitted its first Abbreviated New Drug Application (ANDA) to the U.SFDA for Sitagliptin Phosphate Tablets USP, 25 mg, 50 mg and 100 mgThis milestone demonstrates Morepen’s growing capabilities in formulation development, analytical science and regulatory filingsThe application is currently under regulatory review.
Looking ahead, Morepen intends to pursue additional U.Sprescription generic filings and distribution opportunities where its established API and pharmaceutical R&D capabilities provide a competitive advantageThe 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 productsThe company serves customers across domestic and international markets.