Ritedose Expands Capacity As Albuterol Shortage Ends

With the FDA formally designating the albuterol inhalation solution 0.5% shortage as resolved, Ritedose Corporation is signaling that the domestic sterile manufacturing infrastructure built during nearly four years of constrained supply is now a standing capability, not a temporary response. For hospital formulary managers and QA directors evaluating inhaled-solution supply chains, that distinction carries operational weight.

The Columbia, S.C.-based CDMO expanded production across multiple albuterol inhalation solution strengths during the shortage period, which began in 2022. In 2025, FDA approved Ritedose's 2.5 mg/0.5 mL concentrated dosage, completing a portfolio that now spans four strengths: 2.5 mg/3 mL (0.083%), 1.25 mg/3 mL, 0.63 mg/3 mL, and the newly approved concentrate. The breadth of that line matters for health systems managing formulary continuity across patient populations, including the approximately 7 million pediatric asthma patients in the U.S.

Capacity additions underpinning that portfolio include the expansion of sterile Blow-Fill-Seal (BFS) manufacturing lines, the installation of a seventh Syntegon packaging line, and the commissioning of a logistics and distribution center at Performance Park. Ritedose describes itself as the largest U.S. manufacturer of BFS products, a form-fill-seal technology that supports sterility assurance without secondary container closure steps, a relevant consideration for sterile inhalation products under 21 CFR Part 211 and current GMP expectations.

The shortage resolution does not reduce near-term demand. Albuterol inhalation solution addresses bronchospasm in patients with reversible obstructive airway disease, and the U.S. patient base exceeds 26 million. Health systems that shifted sourcing arrangements during the shortage period will now face formulary decisions about whether to consolidate inhaled-solution supply with a domestic CDMO or maintain diversified sourcing as a hedge against future disruption.

President and CEO Jody Chastain noted that investments made since 2022 position the company as a long-term inhaled-solutions partner for hospitals and health systems, with the capacity infrastructure now in place to absorb sustained demand beyond the shortage period.

The measurable test of that positioning will be Ritedose's ability to maintain supply continuity and regulatory compliance across all four albuterol strengths as market demand normalizes following the FDA's shortage resolution designation.

Source: The Ritedose Corporation via GlobeNewswire, September 24, 2026.