New whitepaper details regulatory requirements needed for transition to low-GWP medical propellants

BOSTON, August 13, 2025—Orbia Fluor & Energy Materials’ pharmaceutical business unit has published a new whitepaper about the industry’s ongoing transition to pressurised metered dose inhalers (pMDIs) to low global warming potential (Low-GWP) propellants.

A leader in the development, manufacture and supply of fluoroproducts Orbia Fluor & Energy Materials (Orbia) has published new research outlining the regulatory environment needed to transition successfully to low-GWP medical propellants for pressurised metered dose inhalers (pMDIs).

The whitepaper, developed in partnership with DLRC Group, focuses on guidance that can support switching propellant for existing medical products.

A 2021 study in the BMJ Open Respiratory Research journal found that switching to pMDIs containing low-GWP propellants can achieve an 89 per cent reduction in total CO2 emissions from inhalers.

Next generation medical propellant products like Orbia’s Zephex® 152a are proven to reduce the carbon emissions of the propellant gas by 90 per cent. 

Low-GWP products like Zephex® 152a directly address the aims from the Kigali Amendment to  the Montreal Protocol, which state the need to reduce hydro-fluorocarbon (HFC) production and  consumption by more than 80 per cent by 2050. 

Orbia and DLRC highlight the stepwise approach advocated by the EMA for demonstrating therapeutic equivalence in the research paper, concluding that the higher solvency power of third generation propellants may require less redevelopment of device components than previous  transitions. 

It also highlights the need for increased collaboration between medical propellant manufacturers,  like Orbia, and pharmaceutical companies to produce robust data packages that support the  transition to low-GWP alternatives.  

A growing number of pharmaceutical companies, like AstraZeneca, Chiesi and GSK, are switching  to low-GWP propellants to meet new regulatory requirements. 

Download the full whitepaper by clicking here.

James Murray, Programme Manager at Orbia Fluor & Energy Materials, and one of the authors of  the paper, said: “With new environmental regulations now coming into effect, there’s a growing low-GWP medical  propellants. Through this paper, we are pleased to be able to demonstrate our support for our  customers who need to navigate this complex regulatory landscape” 

Ian Ashurst, Principal Regulatory Consultant at DLRC, said: “This is the second time that the pharmaceutical industry has been through a propellant transition with pMDIs; the first time was in  the 1990s when the ozone depleting CFC-based propellants were replaced with the current HFA  propellants. That was a difficult and prolonged transition. Significant learnings have been taken  from that experience, and the current transition is expected to be much smoother. Our joint  whitepaper will help companies understand the background and the regulatory requirements for  this current transition to ensure their developments are efficient and effective.”  

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About Orbia Fluor & Energy Materials

Orbia’s Fluor & Energy Materials business is a global leader in the development, manufacture and supply of fluoroproducts that play a fundamental role in enhancing everyday lives and shortening the path to a sustainable, circular economy. Backed by over 35 years of experience, Orbia F&EMproducts are used in a vast range of applications, including electric vehicles and energy storage, urban and rural infrastructure, indoor climate management, food and medicine refrigeration, and even treating respiratory conditions through development of healthy and innovative low-GWP propellants for metered- dose inhalers. Orbia has 1,700 employees and eight manufacturing facilities worldwide, serving 60 countries through a global sales and distribution network. To learn more, visit: orbia.com

About DLRC

DLRC is a dedicated consultancy team of highly qualified and experienced Regulatory Affairs professionals who have come from pharmaceutical company and regulatory agency backgrounds. We have provided our services to over 130 © DLRC Group www.kouraglobal.com | www.dlrcgroup.com 10 companies of all sizes and backgrounds, enabling them to achieve their strategic and operational development objectives. DLRC’s expertise and flexible working approach ensure a highly motivated team that interacts effectively with clients and regulators globally and supports both single-issue and long-term commitment to projects. To learn more, visit dlrcgroup.com 

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