Elite Pharmaceuticals ELTP

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and the manufacture of generic pharmaceuticals. The company focuses on developing generic versions of controlled-release drug products with high barriers to entry. Elite Pharmaceuticals, Inc. occupies manufacturing, warehouse, laboratory and office space at its Northvale Facility in Northvale, New Jersey, which operates under Current Good Manufacturing Practice and is registered with the United States Drug Enforcement Agency for research, development, and manufacturing.

Elite Pharmaceuticals, Inc. generates revenue through the manufacturing, sale, distribution, and licensing of generic pharmaceutical products. The company owns, licenses, manufactures, sells, distributes, or receives royalties from a range of commercial products including generic equivalents of Adipex-P®, Bontril®, Adderall®, Adderall XR®, Vyvanse®, Norco®, Percocet®, Methadone, and others. Revenue is derived from direct sales under its own label, licensing agreements, royalty collection, and third-party manufacturing arrangements. The company serves wholesale distributors, retail pharmacies, and institutional buyers through its Elite Labs label and partner distribution networks.

The company operates through the following segments:

• ANDA: This segment includes generic pharmaceutical products whose marketing approvals were secured via an Abbreviated New Drug Application. Elite Pharmaceuticals, Inc. develops, manufactures, and distributes generic solid oral dose products, both immediate-release and controlled-release, under this segment. Products include Phentermine 37.5mg tablets, Phentermine 15mg and 30mg capsules, Phendimetrazine 35mg tablets, Naltrexone 50mg tablets, Isradipine 2.5mg and 5mg capsules, Trimipramine 25mg, 50mg, and 100mg capsules, Amphetamine IR and ER tablets and capsules, Dantrolene 25mg, 50mg, and 100mg capsules, Loxapine 5mg, 10mg, 25mg, and 50mg capsules, Methotrexate 2.5mg tablets, APAP Codeine and Hydrocodone tablets, Lisdex capsules, Oxy APAP tablets, and Methadone tablets. These products are manufactured at the Northvale Facility and distributed by Elite Labs or through licensing partners such as Prasco, LLC and Dexcel Ltd. The ANDA segment generated $148.9 million in revenue for the year ended March 31, 2026.

Elite Pharmaceuticals, Inc. operates within the highly regulated generic pharmaceutical industry, where it competes with other generic drug manufacturers and authorized generic products. The company's competitive advantages include its focus on controlled-release formulations with high barriers to entry, its cGMP-compliant and DEA-registered manufacturing facility, and its diversified pipeline of generic products across multiple therapeutic categories. Its strategy of developing generic versions of branded drugs with complex formulations helps mitigate risks associated with market exclusivity periods and pricing pressures.

Elite Pharmaceuticals, Inc. serves wholesale pharmaceutical distributors, retail pharmacy chains, institutional healthcare providers, and government purchasers. Specific customer names are not disclosed in the filing, but the company distributes its products through its own Elite Labs label and via third-party partners including Prasco, LLC for Amphetamine ER Capsules and Dexcel Ltd for the Israeli market distribution of Amphetamine IR Tablets. The company's products are ultimately dispensed to patients through retail and institutional pharmacy channels following prescription by healthcare providers.