CATALYST PHARMACEUTICALS, INC

Catalyst Pharmaceuticals, Inc. specializes in the manufacturing of specialty pharmaceutical preparations, with a focused expertise in the production of amifampridine phosphate (marketed as FIRDAPSE), a prescription medication used to treat rare neuromuscular disorders such as Lambert-Eaton myasthenic syndrome. The company demonstrates deep technical proficiency in active pharmaceutical ingredient processing, tablet formulation, and packaging of controlled-release dosage forms compliant with FDA cGMP standards. Their capability extends to the supply of bulk pharmaceutical agents and finished dosage products under strict regulatory oversight, ensuring consistent quality and batch traceability for mission-critical therapeutics. The precision required in manufacturing this high-potency compound underscores their specialization in niche, low-volume, high-complexity pharmaceutical production. The Department of Veterans Affairs is the primary federal partner, consistently procuring FIRDAPSE and associated bulk pharmaceutical components to support veterans with rare neurological conditions. This sustained relationship indicates a trusted supplier status within VA’s specialty drug distribution network, likely supporting the Veterans Health Administration’s pharmacy benefit management system and specialty pharmacy programs. Catalyst operates exclusively within NAICS 325412, positioning itself as a niche manufacturer of orphan drugs and specialty pharmaceuticals rather than a broad-spectrum producer. Their market focus is on therapeutics for ultra-rare diseases requiring stringent manufacturing controls and regulatory agility, distinguishing them within the specialty pharma segment. As a privately held entity headquartered in Coral Gables, Florida, Catalyst Pharmaceuticals, Inc. maintains a focused operational footprint aligned with federal pharmaceutical supply chain requirements. While no government certifications are listed, their consistent delivery of FDA-regulated products to federal agencies confirms adherence to federal quality and compliance standards. Their geographic presence supports direct distribution to federal medical facilities, reinforcing their role as a reliable provider in the government’s rare disease treatment ecosystem.