Elite 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.

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.

Products and 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.

Customers and end 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.

Value-chain role

Manufacturer and marketer of generic pharmaceuticals. Conducts in-house formulation development and regulatory submissions (ANDAs, NDAs). Operates its own FDA- and DEA-registered manufacturing facilities. Sources active pharmaceutical ingredients and raw materials from more than 20 suppliers, with some materials available from only one or a limited number of suppliers.

Geographic exposure

United States. The filing does not disclose international revenue or operations.

Competitors

Pfizer, Sandoz (Novartis), Mylan Laboratories, Teva Pharmaceuticals Industries, Amneal Laboratories, Endo Pharmaceuticals, Mallinckrodt Pharmaceuticals, Aurobindo Pharma USA

Source: SEC 10-K, filed 2025-06-30

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