Aptar Awarded US FDA Contract to Study Opportunities for Low Global Warming Potential Propellants for Metered Dose Inhalers
AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, is announcing a contract with the U.S. Food and Drug Administration (FDA) to study the challenges with developing low Global Warming Potential (low-GWP) propellant metered dose inhalers (MDIs).
- AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, is announcing a contract with the U.S. Food and Drug Administration (FDA) to study the challenges with developing low Global Warming Potential (low-GWP) propellant metered dose inhalers (MDIs).
- View the full release here: https://www.businesswire.com/news/home/20231204794277/en/
Moreover, Aptar’s study will help to define the potential target product profile of low-GWP propellant MDIs to achieve comparability in critical quality attributes (CQAs) to existing MDIs. - Additional capabilities Aptar can provide include pilot manufacturing / process, analytical methods offering alternative pathways to clinical trials, formulation development, metering valve technology and more.
- Moreover, the study is expected to support the ongoing FDA efforts to provide guidance on the regulatory framework with respect to the evaluation and approval of low-GWP propellant MDIs.