Shares of Morepen Labs Ltd. gained as much as 5% in intraday trade on Monday November 9, snapping an eight session losing streak, after it announced the launch of its first prescription generic product for distribution in the US markets.
The company said that it had launched its first prescription generic product Desloratadine Tablets USP, 5 mg, in 100-count and 500-count packs in the country’s market according to a regulatory filing on Monday.
The distribution will be undertaken through the company’s wholly-owned US arm named Morepen Bio Inc.
Morepen has supplied Desloratadine Active Pharmaceutical Ingredient (API) to the US market for several years. The latest launch marks its entry into finished-dosage medicines and distribution in the US.
“Our long-standing API relationships in regulated markets provide a strong foundation for Morepen’s next phase of growth, said Sanjay Suri, Managing Director of the company. He said the company was selectively expanding beyond its CDMO business into finished-dosage development and US distribution.
The move into prescription generics follows Morepen’s earlier launch of over-the-counter (OTC) products in the US.
Additionally, Morepen has submitted its first Abbreviated New Drug Application (ANDA) to the US FDA for Sitagliptin Phosphate Tablets USP in 25 mg, 50 mg and 100 mg strengths, according to the filing.
An ANDA is the US FDA’s regulatory pathway for approving generic drugs. It allows manufacturers to market generic versions of approved medicines by demonstrating bioequivalence to the original drug, without repeating full clinical trials.
Morepen also plans to pursue additional US prescription generic filings and distribution opportunities, leveraging its existing API and pharmaceutical R&D capabilities, the filing noted.
The company said that it may also explore opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements and market conditions.
Market Reaction
Shares of Morepen Labs are trading 4.8% higher after the announcement on Monday at ₹98.99. The stock has already risen 141% so far this year.
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Morepen Labs shares jump 5%, snap eight-day losing streak on US generic drug market foray