Orbia Fluor & Energy Materials (Orbia F&EM), has announced a US regulatory milestone for Zephex 152a; its next generation, low global warming potential (low-GWP) propellant for pressurised metered dose inhalers (pMDIs).
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Orbia F&EM has established a US Type IV Drug Master File (DMF) for Zephex 152a as required for excipients, creating a complete, ready-to-use, FDA-formatted data package that pharmaceutical companies can reference directly in their submissions to the US Food and Drug Administration (FDA).
The milestone comes as the respiratory industry accelerates its transition toward more sustainable solutions, driven by the US, European and UK environmental regulations - including the phase down of high-GWP propellants - which are advancing the adoption of lower-carbon alternatives.
Zephex 152a is shown to reduce the carbon footprint of the propellant within pMDIs by 90% and will therefore play a critical role in the performance, quality and safety of the next generation of pMDIs.
The DMF provides FDA reviewers with direct access to detailed information on how the propellant is manufactured, controlled, and tested in accordance with FDA requirements, without requiring companies to recreate or resubmit the same technical data.
By enabling cross-referencing to a single, established excipient file, the DMF helps to reduce regulatory risk, limit repetition in technical work, and support more efficient FDA reviews.
This translates into shorter review timelines and smoother assessments, particularly for companies transitioning existing inhalers or developing new pMDIs using next generation, lower-GWP propellants.
As the same DMF can be used from early development through commercialisation, it also makes it easier to scale from clinical programs to full manufacture, supporting long-term supply and lifecycle management.
Markus Laubscher, head of the pharma business unit at Orbia Fluor & Energy Materials, said: “The launch of the U.S. Type IV DMF marks an important milestone for Zephex 152a, providing our customers with a strong regulatory foundation to develop low-GWP respiratory treatments for the U.S. market and facilitating a smoother transition from development to commercial supply.”
“As the industry works towards this transition, continuity is critical. Orbia F&EM will continue to supply and support our customers with Zephex 134a, the established medical propellant, drawing on decades of experience to act as a trusted and reliable partner - supporting immediate needs while helping customers progress toward their long-term sustainability goals.”