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..

伊利诺伊州水晶湖。-（商业新闻短讯）--药品和消费品给药、配药和保护技术的全球领导者AptarGroup，Inc.（纽约证券交易所：ATR）宣布，其N-吸附亚硝胺缓解解决方案已被美国食品和药物管理局（FDA）新兴技术计划（ETP）接受，该计划有助于促进采用创新方法进行药品设计和制造。。

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.

N-Sorb利用Aptar CSP Technologies经验证的三相Activ Polymer™平台技术来解决药物中N-亚硝胺杂质的紧迫问题。这些被归类为可能的人类致癌物的杂质引起了监管部门的极大关注，并引发了众多药品召回。

Nitrosamines can form during drug product storage or transport, posing risks to patient health..

在药品储存或运输过程中会形成亚硝胺，对患者健康构成风险。。

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.

通过将活性材料科学整合到聚合物中，N-Sorb技术可以以多种形式部署。例如，该技术可以整合到泡罩格式中，将一块N-Sorb Activ Film™材料集成到每个单独的Activ泡罩™腔中。这一平台目前受到全球品牌的信赖，可以保护敏感的活性药物成分（API）免受水分和氧气的降解。

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..

或者，该技术可以无缝集成到容器封闭系统中。N-Sorb的智能设计使其能够与包装顶部空间中的亚硝胺前体反应，以抑制亚硝胺的形成并清除形成后的亚硝胺杂质。。

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.

通过直接在包装内提供这种公认的安全（GRAS）材料，N-Sorb可以消除药物开发人员重新配制药品的需要，这可以支持遵守美国FDA和欧盟EMA关于安全亚硝胺水平的法规。主动包装干预代表了管理杂质和降解的范式转变，这可以显着增强整体缓解策略，并符合FDA最新指南（9月更新）。

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..

42024），将包装变化视为潜在的缓解策略。通过使用活性包装解决亚硝胺问题，N-Sorb技术可以帮助加速药品开发，并有助于减轻召回导致的药品短缺负担。。

“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.

亚太CSP Technologies全球商业运营副总裁兼总经理巴德雷·哈蒙德（BadreHammond）表示：“FDA的新兴技术计划具有高度选择性，专为最有前途的制药和医疗保健行业解决方案而设。”。“我们通过活性材料科学减轻亚硝胺形成的能力引入了一个关键的质量控制元素，旨在确保患者安全。

We are eager to collaborate with the FDA’s Emerging Technology team to empower pharma brands with this innovative offering.”.

我们渴望与FDA的新兴技术团队合作，为制药品牌提供这种创新产品。”。

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..

作为该计划的一部分，行业代表与FDA的新兴技术团队成员会面，讨论、确定和解决在提交监管之前与新技术的开发和实施相关的潜在技术和监管问题。这一多方利益相关者的努力符合FDA的使命，即促进制药行业的现代化，减少引入新解决方案的时间和成本要求。。

About Aptar

关于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.

亚太地区是全球药品和消费品剂量、配药和保护技术的领导者。亚太地区服务于许多有吸引力的终端市场，包括制药、美容、食品、饮料、个人护理和家庭护理。Aptar CSP Technologies利用其活性材料科学专业知识将想法转化为市场机会，加速产品开发过程并降低风险，并提供改善消费者和患者生活的完整解决方案。

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..

该公司提供从概念构思、设计和工程设计到产品开发、全球生产、质量控制和监管支持的全套服务，加快了上市速度。有关更多信息，请访问www.csptechnologies.com和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.

本新闻稿包含前瞻性声明。前瞻性陈述通常可以通过与历史或当前事实不严格相关的事实来识别，并且可以使用诸如“期望”、“预期”、“相信”、“估计”、“未来”、“潜在”、“继续”和其他类似的表达或未来或条件动词，例如“将”、“应该”、“将”和“可能”来识别此类前瞻性陈述。

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.

前瞻性陈述是根据1933年《证券法》第27A节和1934年《证券交易法》第21E节的安全港规定做出的，并基于我们的信念以及我们所做的假设和目前可用的信息。因此，由于我们的运营和业务环境中存在已知或未知的风险和不确定性，我们的实际结果或其他事件可能与此类前瞻性陈述中明示或暗示的结果或其他事件存在重大差异，包括但不限于：收购的成功整合；监管环境；和竞争，包括技术进步。

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.

有关这些以及其他风险和不确定性的更多信息，请参阅我们向美国证券交易委员会提交的文件，包括我们表格10-K和表格10-Q中“风险因素”和“管理层对财务状况和经营成果的讨论和分析”下的讨论。

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..

我们没有义务公开更新任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律另有要求。。