Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program

Rhea-AI Summary

AptarGroup, Inc. (NYSE: ATR) announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. FDA's Emerging Technology Program (ETP). N-Sorb uses Aptar CSP Technologies' 3-Phase Activ-Polymer™ platform to address N-nitrosamine impurities in pharmaceuticals, which are classified as probable human carcinogens.

The technology can be integrated into blister packaging or container closure systems, reacting with nitrosamine precursors and scavenging impurities. This active packaging intervention could eliminate the need for drug reformulation, supporting compliance with FDA and EMA regulations. The FDA's acceptance of N-Sorb into the ETP is seen as a significant step, as the program is highly selective and reserved for promising healthcare solutions.

Positive

• N-Sorb accepted into FDA's Emerging Technology Program, indicating potential for industry adoption
• Technology addresses critical issue of N-nitrosamine impurities in pharmaceuticals
• Could eliminate need for drug reformulation, potentially saving time and resources for pharmaceutical companies
• Aligns with latest FDA guidance on packaging changes as a mitigation strategy
• May help accelerate drug product development and alleviate drug shortages due to recalls

Negative

• None.

Insights

Pharmaceutical Industry Expert

The acceptance of Aptar's N-Sorb technology into the FDA's Emerging Technology Program is a significant development for the pharmaceutical industry. This innovative solution addresses the critical issue of N-nitrosamine impurities, which have led to numerous drug recalls and safety concerns. The technology's ability to mitigate nitrosamine formation without requiring drug reformulation could be a game-changer for pharmaceutical companies.

Key points to consider:

• N-Sorb leverages Aptar's 3-Phase Activ-Polymer™ technology, which is already trusted in protecting sensitive APIs.
• The solution can be integrated into blister packs or container closure systems, offering flexibility in application.
• It aligns with the FDA's latest guidance on packaging changes as a mitigation strategy.
• The technology could potentially accelerate drug development and help reduce drug shortages due to recalls.

While this news is positive for Aptar and the industry, it's important to note that acceptance into the ETP is just the beginning. The technology still needs to prove its effectiveness and gain widespread adoption to have a significant impact on Aptar's bottom line and the broader pharmaceutical market.

Regulatory Affairs Specialist

The FDA's acceptance of Aptar's N-Sorb technology into the Emerging Technology Program (ETP) is a noteworthy regulatory development. This program is highly selective and designed to facilitate the adoption of innovative approaches in pharmaceutical manufacturing. Key regulatory implications include:

• Potential for expedited regulatory review and approval processes for products using N-Sorb technology.
• Alignment with FDA's focus on modernizing pharmaceutical manufacturing and quality control.
• Opportunity for Aptar to collaborate directly with FDA experts to address technical and regulatory challenges early in the development process.
• Possible influence on future regulatory guidance related to nitrosamine mitigation strategies.

The technology's GRAS (Generally Recognized as Safe) status and its potential to help companies comply with FDA and EMA regulations on nitrosamine levels are significant advantages. However, it's important to remember that inclusion in the ETP does not guarantee regulatory approval or market success. The coming months will be critical as Aptar works with the FDA to demonstrate the technology's effectiveness and safety in real-world applications.

N-Sorb leverages company’s proven 3-Phase Activ-Polymer™ platform technology to address recent concerns related to N-nitrosamine impurities in pharmaceuticals

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)-- AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. Food & Drug Administration’s (FDA) Emerging Technology Program (ETP), which helps promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Aptar’s N-Sorb Nitrosamine Mitigation Solution. (Photo: Business Wire)

N-Sorb leverages Aptar CSP Technologies’ proven 3-Phase Activ-Polymer™ platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as probable human carcinogens, have raised significant regulatory concerns and prompted numerous drug product recalls. Nitrosamines can form during drug product storage or transport, posing risks to patient health.

N-Sorb technology can be deployed in multiple formats by integrating active material science into polymers. For example, the technology can be incorporated into a blister format that integrates a piece of N-Sorb Activ-Film™ material into each individual Activ-Blister™ cavity. This same platform is currently trusted by global brands to protect sensitive Active Pharmaceutical Ingredients (APIs) from degradation due to moisture and oxygen exposure. Alternatively, the technology can be seamlessly integrated into a container closure system. N-Sorb’s intelligent design allows it to react with nitrosamine precursors in the packaging headspace to inhibit nitrosamine formation and scavenge nitrosamine impurities post-formation.

By delivering this Generally Recognized as Safe (GRAS) material directly within the packaging, N-Sorb can eliminate the need for pharmaceutical developers to reformulate their drug products, which could support compliance with US FDA and EU EMA regulations regarding safe nitrosamine levels. The active packaging intervention represents a paradigm shift in managing impurities and degradation, which could significantly enhance overall mitigation strategies and aligns with the latest FDA guidance (updated Sept. 4, 2024) that recognizes packaging changes as a potential mitigation strategy. By addressing nitrosamine concerns with active packaging, N-Sorb technology can help accelerate drug product development and help alleviate the burden of drug shortages due to recalls.

“The FDA’s Emerging Technology Program is highly selective, reserved for the most promising pharma and healthcare sector solutions,” said Badre Hammond, VP Global Commercial Operations and GM for Aptar CSP Technologies. “Our ability to mitigate nitrosamine formation with active material science introduces a critical quality control element, designed to ensure patient safety. We are eager to collaborate with the FDA’s Emerging Technology team to empower pharma brands with this innovative offering.”

As part of the program, industry representatives meet with the FDA’s Emerging Technology Team members to discuss, identify and resolve potential technical and regulatory issues related to the development and implementation of novel technologies prior to regulatory submission. This multi-stakeholder effort aligns with the FDA’s mission to facilitate modernization in the pharmaceutical industry, reducing time and cost requirements for introducing novel solutions.

About Aptar

Aptar is 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 CSP Technologies leverages its active material science expertise to transform ideas into market opportunities, accelerate and de-risk the product development process, and provide complete solutions that improve consumers’ and patients’ lives. The company offers a complete set of services from concept ideation, to design and engineering, to product development, global production, quality control, and regulatory support that results in expedited speed-to-market. For more information, please visit www.csptechnologies.com and www.aptar.com.

This press release contains forward-looking statements. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of 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 Form 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 otherwise required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240923964121/en/

Aptar Investor Relations Contact:

Mary Skafidas

mary.skafidas@aptar.com

+1 347 351 6407

Aptar Media Contact

Katie Reardon

katie.reardon@aptar.com

+1 815 479 5671

Aptar CSP Technologies Media Contact:

Tricia Dozier

tricia.dozier@aptar.com

315-521-4555

Source: AptarGroup, Inc.

FAQ

What is Aptar's N-Sorb technology and how does it work?

N-Sorb is a nitrosamine mitigation solution that uses Aptar's 3-Phase Activ-Polymer™ platform. It can be integrated into packaging to react with nitrosamine precursors and scavenge impurities, potentially eliminating the need for drug reformulation.

Why is the acceptance of N-Sorb into the FDA's Emerging Technology Program significant for ATR stock?

The acceptance indicates that N-Sorb is considered a promising solution in the pharmaceutical industry. This could lead to increased adoption of the technology, potentially boosting Aptar's revenue and market position.

How might N-Sorb technology impact the pharmaceutical industry and ATR's market potential?

N-Sorb could help pharmaceutical companies comply with regulations, avoid recalls, and accelerate drug development. This could create a significant market opportunity for Aptar (ATR) in the pharmaceutical packaging sector.

What are the potential benefits of N-Sorb for pharmaceutical companies using ATR's technology?

N-Sorb could help companies avoid costly drug reformulations, comply with FDA and EMA regulations, reduce the risk of recalls, and potentially accelerate drug product development, all of which could lead to cost savings and faster time-to-market.