Orbia announces submission of DMF for Zephex 152a LGWP MDI propellant

Orbia Fluor & Energy Materials (previously Koura, Mexichem) has announced the submission of a drug master file for its HFA 152a MDI propellant, marketed as Zephex 152a. The company kicked off the transition to low global warming potential propellants in 2016 when Mexichem began promoting the potential of HFA 152a as an LGWP propellant, and in 2019, Chiesi announced that it had signed an agreement for supply of Zephex 152a as part of its plan to bring an LGWP MDI to market by the end of 2025.

Koura opened a small-scale Zephex 152a manufacturing facility in 2022 and in December 2024, Orbia announced plans for a commercial-scale Zephex 152a manufacturing facility. In October 2025, Orbia announced its first delivery of an ISO tank of Zephex 152a.

Orbia Fluor & Energy Materials Head of the Pharma Business Unit Markus Laubscher commented, “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.” 

Laubscher continued, “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.” 

Read the Orbia press release

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