Aptar Awarded US FDA Contract to Study Opportunities for Low Global Warming Potential Propellants for Metered Dose Inhalers
04 Dezembro 2023 - 10:30AM
Business Wire
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).
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Photo: Aptar
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.
With this study, Aptar will support the FDA with its
industry-leading research and development center and respiratory
team, which is enhanced by state-of-the-art technologies and the
know-how to develop complex orally inhaled and nasal drug products
(OINDP). Additional capabilities Aptar can provide include pilot
manufacturing / process, analytical methods offering alternative
pathways to clinical trials, formulation development, metering
valve technology and more.
The result of Aptar’s study is designed to provide the FDA with
information related to the formulation, manufacture, device design
and quality aspects related to low-GWP propellant MDIs and their
utility to replace existing propellant MDIs. 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. The results of the study will
be reviewed and discussed with the agency as detailed case studies,
which can then be published as scientific publications and
conference presentations.
Guillaume Brouet, VP of Aptar Pharma Analytical Regulatory and
Scientific Affairs, said, “Our leading OINDP research company,
Nanopharm, alongside with our Pharma segment’s research and
development team, is delighted to support the FDA on this important
study to better define the design space for developing low-GWP MDIs
with equivalent performance to existing propellant MDIs.”
The contracted work, including “optional contract line items”,
is valued at up to approximately $6 million.
About Aptar
Aptar Pharma is part of AptarGroup, Inc., a global leader in
drug and consumer product dosing, dispensing and protection
technologies. Aptar serves a number of attractive end markets
including pharmaceutical, beauty, food, beverage, personal care and
home care. Aptar Pharma’s analytical, laboratory and regulatory
services add value at every stage of the drug development process,
accelerating and de-risking the program along the way. Nanopharm
Ltd., an Aptar Pharma company, is a leading provider of specialized
analytical and product development services, with a focus on orally
inhaled and nasal drug products. Aptar is headquartered in Crystal
Lake, Illinois and has 13,500 dedicated employees in 20 countries.
For more information, visit www.aptar.com.
This press release contains forward-looking statements,
including regarding the outcome and value of the Aptar
Pharma/Nanopharm study. Words such as “expects,” “anticipates,”
“believes,” “estimates,” “future,” “potential,” “continues” and
other similar expressions or future or conditional verbs such as
“will,” “should,” “would” and “could” are intended to identify such
forward-looking statements. Forward-looking statements are made
pursuant to the safe harbor provisions of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and are based on our beliefs as well as assumptions
made by and information currently available to us. Accordingly, our
actual results or other events may differ materially from those
expressed or implied in such forward-looking statements due to
known or unknown risks and uncertainties that exist in our
operations and business environment including, but not limited to:
the successful integration of acquisitions; the regulatory
environment; and competition, including technological advances. For
additional information on these and other risks and uncertainties,
please see our filings with the Securities and Exchange Commission,
including the discussion under “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” in our Forms 10-K and Forms 10-Q. We undertake no
obligation to update publicly any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
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Aptar Investor Relations
Contact: Mary Skafidas mary.skafidas@aptar.com +1 347
351 6407
Aptar Pharma Media Contact:
Carolyn Penot Carolyn.penot@aptar.com +33 1 3917 2038
Aptar Media Contact Katie
Reardon katie.reardon@aptar.com +1 815 479 5671
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