Orbia Fluor & Energy Materials (Orbia F&EM) has announced that it has created a US Type IV Drug Master File (DMF) for Zephex 152a as required for excipients.
Pharmaceutical companies can now directly reference the complete, ready-to-use, FDA-formatted data package in their submissions to the US Food and Drug Administration (FDA).
Zephex 152a is the company's next-generation, low global warming potential (GWP) propellant for pressurised metered dose inhalers (pMDIs).
Why this matters
The milestone reflects the respiratory industry's shift towards more sustainable solutions, driven by environmental regulations in the US, Europe and the UK.
These regulations include a phasedown of high-GWP propellants, which are encouraging the adoption of lower-carbon alternatives.
Zephex 152a significantly reduces the carbon footprint of propellants used in pMDIs by 90%.
As a result, it will play a crucial role in enhancing the performance, quality and safety of the next generation of pMDIs.
The DMF provides FDA reviewers with direct access to detailed information on propellant manufacturing and testing in compliance with FDA standards, eliminating the need for companies to duplicate technical data.
By allowing cross-referencing to a single excipient file, the DMF reduces regulatory risks and minimises redundant work, leading to shorter review timelines and smoother assessments.
This is particularly beneficial for companies transitioning existing inhalers or developing new low-global warming potential (GWP) propellant pMDIs.
Additionally, using the same DMF from early development through commercialisation simplifies the scaling process from clinical programmes to full production, 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 US 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 US 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."