In January management introduced full-year 2026 revenue guidance of $300–$320 million, including $150–$170 million from its lead antimicrobial catheter lock solution. This conservative outlook, assuming flat usage and excluding potential new account wins or reimbursement shifts, triggered investor caution and a 27% share decline over three months.

Amphastar controls the entire enoxaparin manufacturing process, from API synthesis to final drug formulation, enabling cost efficiencies and supply reliability. This vertical integration positions Amphastar to pivot its heparin portfolio toward catheter-related bloodstream infection prevention with minimal incremental capital expenditure.

The catheter-related bloodstream infection prevention market remains underserved, with DefenCath as the only FDA-approved therapy. Amphastar’s technical expertise in heparin derivatives could allow rapid development or repurposing of existing products to capture market share as CorMedix scales cautiously.

Besides Amphastar, large players such as Pfizer, B. Braun and Baxter hold significant heparin capacity and broad pipelines, posing potential threats. Amphastar’s success will depend on securing reimbursement contracts, Medicare Advantage coverage and demonstrating clinical efficacy in CRBSI prophylaxis studies.