NSEPress Release21h ago · 9 Nov 2026, 08:53 am

Press Release

Morepen Laboratories Limited · MOREPENLAB

✦ AI Summary▲ PositiveExpansion

Morepen Laboratories Limited 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.

Analysis Scores

Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk5/10
Liquidity Impact9/10
Market Sentiment8/10

✦ Ask a Question

Ask anything about this announcement — AI will answer based on the filing content.

0/500

Full Announcement

Morepen Laboratories Limited has informed the Exchange regarding a press release dated November 09, 2026, titled "Morepen enters U.S. prescription generics market, building on its established API strengths".

Attachments (1)

📄

MOREPENLAB_09112026085234_SEinPressrelease91126.pdf

pdf

Download →
View document text
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