Elite Pharmaceuticals Inc
elitepharma.comElite Pharmaceuticals Inc (OTC: ELTP) is a pharmaceutical company that manufactures and markets generic drug products approved via Abbreviated New Drug Applications (ANDAs). Revenue comes from selling FDA-approved generic pharmaceuticals, with the company generating $84.0 million in ANDA segment revenue for the fiscal year ended March 31, 2025, up from $56.6 million in FY2024. The NDA (branded) segment produced $0.0 million in revenue in both FY2025 and FY2024, making the business entirely dependent on generics at present. ELTP competes against substantially larger generic and branded pharmaceutical manufacturers, operates FDA- and DEA-registered manufacturing facilities, and sources raw materials from more than 20 suppliers as of the 10-K filed June 30, 2025. The company also has a paused branded drug development program, SequestOx, an abuse-deterrent opioid formulation pursued under an NDA pathway.
Products & Services
Generic pharmaceutical products approved via ANDAs. Branded pharmaceutical pipeline includes SequestOx, a controlled-release, abuse-deterrent opioid formulation, development of which is currently paused. The company focuses on technically difficult-to-formulate generics and products requiring advanced manufacturing technology.
Revenue Model
Transactional product sales of FDA-approved generic pharmaceuticals (ANDA segment). ANDA segment revenue was $84.0 million in FY2025 and $56.6 million in FY2024. NDA segment revenue was $0.0 million in both periods. Revenue is subject to chargeback reserves reflecting price adjustments negotiated through distribution channels.
Customers & Markets
Pharmaceutical distribution channels typical of the U.S. generic drug market, including entities that negotiate chargeback arrangements. End markets include retail pharmacy and institutional healthcare. No specific customer concentration percentages are disclosed in the filing excerpts.
Geographic Exposure
United States. The filing does not disclose international revenue or operations.
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