Ritedose expands BFS packaging capacity as FDA ends albuterol shortage
The FDA has formally declared the four-year albuterol inhalation solution shortage resolved, and US contract manufacturer Ritedose says the sterile blow-fill-seal (BFS) capacity it built during the shortage is now permanent infrastructure. The Columbia, South Carolina-based CDMO added a seventh Syntegon packaging line and a new logistics centre at its Performance Park site, and gained FDA approval in 2025 for a fourth albuterol strength, completing a four-strength product line.
Why this mattersSustained domestic BFS capacity for a critical respiratory drug reduces reliance on diversified or offshore sourcing for US hospital systems.
- FDA declared the albuterol inhalation solution 0.5% shortage, which began in 2022, formally resolved.
- Ritedose installed a seventh Syntegon packaging line as part of its capacity expansion.
- Ritedose commissioned a logistics and distribution centre at its Performance Park site.
- FDA approved Ritedose's 2.5 mg/0.5 mL concentrated albuterol dosage in 2025, completing a four-strength portfolio.
- Ritedose describes itself as the largest US manufacturer of BFS products.
- The US albuterol patient base exceeds 26 million, including about 7 million paediatric asthma patients.
Sources
pharmanow.live