Morepen climbs on strengthening integrated CDMO capabilities with first U.S. ANDA submission
Morepen Laboratories is currently trading at Rs. 123.75, up by 3.30 points or 2.74% from its previous closing of Rs. 120.45 on the BSE.
The scrip opened at Rs. 121.00 and has touched a high and low of Rs. 126.10 and Rs. 119.40 respectively. So far 982753 shares were traded on the counter.
The BSE group 'B' stock of face value Rs. 2 has touched a 52 week high of Rs. 126.90 on 21-Sep-2026 and a 52 week low of Rs. 33.44 on 30-Mar-2026.
Last one week high and low of the scrip stood at Rs. 126.90 and Rs. 115.95 respectively. The current market cap of the company is Rs. 6761.75 crore.
The promoters holding in the company stood at 35.65%, while Institutions and Non-Institutions held 2.75% and 61.59% respectively.
Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (USFDA) for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The submission extends the company’s established API and CDMO expertise into integrated finished dosage development and regulatory filing.
The Sitagliptin program brings together formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacture of regulatory batches under GMP systems. It also incorporates bioequivalence strategy, coordination with contract research organizations and integration of development and study data into the regulatory dossier. These capabilities strengthen the company’s ability to support specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programs it can undertake.
The company is targeting to build on this foundation through customer development programs, technology transfer, co-development and licensing opportunities. These capabilities can also support product and dossier development for regulated markets across Europe and Asia, tailored to each jurisdiction’s requirements. Over time, the company aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programs, subject to product-specific studies and regulatory requirements.
