Morepen Laboratories spurts on launch of first US prescription generic drug
The launch marks the company's entry into finished-dosage medicines and US distribution, extending its presence beyond API supplies. The move is part of its broader strategy to expand its pharmaceutical research and development (R&D), contract development and manufacturing (CDMO) and formulations businesses.
Separately, Morepen has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin Phosphate Tablets USP in strengths of 25 mg, 50 mg and 100 mg. The application is currently under regulatory review.
The company said it plans to pursue additional US prescription generic filings and distribution opportunities, leveraging its API and pharmaceutical R&D capabilities. It may also evaluate opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements and market conditions.
Morepen Laboratories is an Indian pharmaceutical and healthcare company with operations spanning active pharmaceutical ingredients, CDMO services, formulations and healthcare products. It serves customers in domestic and international markets.
On a consolidated basis, Morepen Laboratories' net profit surged 117.49% to Rs 88.89 crore while net sales rose 81.37% to Rs 746.50 crore in Q2 September 2026 over Q2 September 2025.
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