Morepen Labs Enters US Prescription Generics Market; Shares Rise 4.31%

Mumbai, November 09: Morepen Laboratories Limited has entered the US prescription generics market with the launch of its first prescription generic product, Desloratadine Tablets USP, in 5 mg strength. The medicine is available in 100-count and 500-count packs and will be distributed through the company’s wholly owned US subsidiary, Morepen Bio Inc.

The launch marks an expansion of Morepen’s presence in the US pharmaceutical market, where it has been supplying Desloratadine active pharmaceutical ingredient (API) for several years. The latest move takes the company further along the pharmaceutical value chain, from supplying drug ingredients to marketing finished-dose medicines.

Morepen Expands Beyond API Business in the US

The company said its established API relationships in regulated markets provide a foundation for expanding into finished-dose pharmaceuticals and strengthening its research and development (R&D) capabilities.

Managing Director Sanjay Suri said the prescription generics launch complements Morepen’s expanding contract development and manufacturing organisation (CDMO) business and reflects its strategy to build a more integrated, R&D-led pharmaceutical business.

The company has also 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.

Morepen Plans Additional Generic Drug Filings

Looking ahead, Morepen intends to pursue additional US prescription generic filings and distribution opportunities by leveraging its established API and pharmaceutical R&D capabilities.

The company may also evaluate opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements and market conditions.

Stock Market Snapshot

The Morepen Laboratories share price was trading at ₹98.50, up ₹4.07 or 4.31% on Monday, November 9, 2026, at 9:20:15 AM IST, compared with the previous close of ₹94.43. The stock opened at ₹93.50.

About Morepen Laboratories

Morepen Laboratories Limited is an Indian pharmaceutical and healthcare company with businesses spanning active pharmaceutical ingredients, contract development and manufacturing services, formulations and healthcare products. It serves customers across domestic and international markets.

Conclusion

Morepen’s entry into the US prescription generics market marks a move beyond its established API supply business. The Desloratadine launch, alongside the pending Sitagliptin ANDA application, reflects the company’s efforts to expand its finished-dose portfolio and build a broader presence in the US pharmaceutical market.

Source:

• https://www.nseindia.com/get-quote/equity/MOREPENLAB/Morepen-Laboratories-Limited
• https://nsearchives.nseindia.com/corporate/MOREPENLAB_09112026085234_SEinPressrelease91126.pdf