BSECompany Update21h ago · 9 Nov 2026, 08:54 am
Please find attached the Press Release
Morepen Laboratories Ltd · 500288
✦ AI Summary▲ PositiveExpansion
Morepen Laboratories Ltd has announced the launch of its first prescription (Rx) generic product, Desloratadine Tablets USP, in the U.S. market, building on its established API position. The company has also submitted its first Abbreviated New Drug Application (ANDA) to the U.S. FDA for Sitagliptin Phosphate Tablets USP. Morepen intends to pursue additional U.S. prescription generic filings and distribution opportunities.
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Morepen Laboratories Ltd - 500288 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
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Date: 09/11/2026
National Stock Exchange of India Ltd. BSE Limited
Exchange Plaza, Bandra Kurla Complex, Phiroze Jeejeebhoy Towers,
Bandra (East), Mumbai- 400 051 Dalal Street, Mumbai- 400 001
Symbol: MOREPENLAB Scrip Code: 500288
Sub.: Press Release – ‘Morepen enters U.S. prescription generics market, building on its established API
strengths’
Dear Sir/ Madam,
Please find enclosed press release with the title ‘Morepen enters U.S. prescription generics market,
building on its established API strengths’.
This is for your information and dissemination on your website.
Thanking you,
Yours faithfully,
For Morepen Laboratories Limited
Vipul Kumar Srivastava
Company Secretary
F-12148
Encl.: a/a
Morepen Laboratories Limited
CIN NO. L24231 HP1984PLC006028
Corp. Off.: 2nd Floor, Tower C, DLF Cyber Park, Udyog Vihar-III, Sector-20, Gurugram, Haryana-122016, INDIA
TEL.: +91 124 4892000, E-mail: corporate@morepen.com, Website: www.morepen.com
Regd. Off.: Morepen Village, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) -173205, INDIA
Tel.: +91 1795 266401-03, 244590, Fax: +91 1795 244591, E-mail: plants@morepen.com
Morepen Enters U.S. Prescription Generics Market, Building on Its
Established API Strengths
Desloratadine Tablets launch complements Morepen’s broader API, R&D and CDMO growth strategy
New Delhi | 9 November 2026
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.
Morepen has been supplying Desloratadine API to the U.S. market for many years. Building on this established
API position, the latest launch extends the company's participation further along the pharmaceutical value chain into
finished-dosage medicines and U.S. distribution.
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.
Media Contacts
Propel Communications
Morepen Laboratories Limited
Girish Singhal
Rajas Suri
Email: propelpr.com@gmail.com
Email: rajas.suri@morepen.com
Mobile: +91 9810206244
Morepen Laboratories Limited
CIN NO. L24231 HP1984PLC006028
Corp. Off.: 2nd Floor, Tower C, DLF Cyber Park, Udyog Vihar-III, Sector-20, Gurugram, Haryana-122016, INDIA
TEL.: +91 124 4892000, E-mail: corporate@morepen.com, Website: www.morepen.com
Regd. Off.: Morepen Village, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) -173205, INDIA
Tel.: +91 1795 266401-03, 244590, Fax: +91 1795 244591, E-mail: plants@morepen.com