BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California. The product is now available for direct distribution to states and municipalities across the U.S..

新泽西州布里奇沃特（商业新闻短讯）--Amneal Pharmaceuticals，Inc.（纳斯达克：AMRX）（“Amneal”或“公司”）今天宣布，它已开始向美国零售药店和加利福尼亚州提供其非处方（OTC）盐酸纳洛酮（Naloxone HCI）鼻喷雾剂USP，4mg。该产品现在可直接分发到美国各州和直辖市。。

The U.S. Food and Drug Administration approved Amneal’s Naloxone HCI Nasal Spray in April 2024. Amneal’s Naloxone HCI Nasal Spray is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses. The Company also entered into a distribution agreement with California to provide Naloxone HCI Nasal Spray through the CalRx® Naloxone Access Initiative.

美国食品和药物管理局于2024年4月批准了Amneal的盐酸纳洛酮鼻喷雾剂。Amneal的盐酸纳洛酮鼻喷雾剂与OTC NARCAN®HCI鼻喷雾剂相当，后者是一种广泛用于治疗阿片类药物过量的药物。该公司还与加利福尼亚州签订了分销协议，通过CalRx®纳洛酮接入计划提供纳洛酮HCI鼻喷雾剂。

Amneal expects to have capacity to produce approximately ten million two-packs annually at its New Jersey manufacturing facility, starting in 2025..

Amneal预计，从2025年开始，其新泽西制造厂的年生产能力约为1000万双包装。。

“Amneal is an industry leader in complex generics with the ability to develop, manufacture and commercialize high-quality medicines that are affordable and accessible. The widespread availability of OTC naloxone will be a critical tool in the fight against the ongoing opioid epidemic. Amneal is proud to be part of the solution,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics..

“Amneal是复杂仿制药领域的行业领导者，能够开发、制造和商业化价格合理且易于获得的高质量药物。非处方纳洛酮的广泛使用将成为对抗持续的阿片类药物流行的关键工具。Amneal很自豪能成为解决方案的一部分，”仿制药执行副总裁兼首席商务官安迪·博耶（Andy Boyer）表示。。

“We are pleased to partner with the State of California on a long-term distribution agreement to make OTC naloxone available to thousands of communities and millions of people. We are actively engaging with other states and municipalities to expand access to this important life-saving product, which is proudly made in America in one of our New Jersey facilities,” said Maryll Toufanian, SVP, Regulatory Strategy and Government Affairs..

“我们很高兴与加利福尼亚州签署长期分销协议，向数千个社区和数百万人提供非处方纳洛酮。我们正在积极与其他州和市政府合作，扩大这种重要的救生产品的使用范围，该产品在美国新泽西州的一家工厂生产，”监管战略和政府事务高级副总裁马里尔·图法尼安（MarylToufanian）表示。。

To learn more about Amneal’s Naloxone HCl Nasal Spray, please visit https://amnealnaloxone.com/.

要了解有关Amneal的盐酸纳洛酮鼻喷雾剂的更多信息，请访问https://amnealnaloxone.com/.

About Naloxone Nasal Spray

关于纳洛酮鼻喷雾剂

Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to rapidly reverse the effects of a life-threatening opioid emergency by binding to opioid receptors in the brain and blocking the effects of opioids. It can restore normal breathing within two to three minutes in a person whose breath has slowed, or even stopped, as a result of an overdose from opioids including heroin, fentanyl and prescription opioid medications.

盐酸纳洛酮（Naloxone HCI）鼻喷雾剂旨在通过与大脑中的阿片受体结合并阻断阿片类药物的作用，快速逆转危及生命的阿片类药物紧急情况的影响。由于服用过量的阿片类药物（包括海洛因、芬太尼和处方阿片类药物），呼吸减慢甚至停止的人，它可以在两到三分钟内恢复正常呼吸。

Amneal’s Naloxone HCI Nasal Spray contains the same active ingredient and dose as NARCAN® Naloxone HCI Nasal Spray, 4 mg. It is available over-the-counter and is easy to carry, and it can be safely used even if opioids are not present in the patient..

Amneal的盐酸纳洛酮鼻喷雾剂含有与NARCAN®盐酸纳洛酮鼻喷雾剂相同的活性成分和剂量，4毫克。它可以在非处方药上买到，携带方便，即使患者体内不存在阿片类药物，也可以安全使用。。

NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

NARCAN®是Emergency Operations Ireland Limited的注册商标。

When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea or feeling angry. This is to be expected.

当使用本产品时，一些人可能会在醒来时出现症状，如颤抖、出汗、恶心或感到愤怒。这是意料之中的。

About Amneal

关于Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

Amneal Pharmaceuticals，Inc.（纳斯达克股票代码：AMRX），总部位于新泽西州布里奇沃特，是一家全球性制药公司。我们通过主要在美国境内开发、制造和分销280多种药品组合，使健康成为可能。在仿制药领域，该公司正在扩展广泛的复杂产品类别和治疗领域，包括注射剂和生物仿制药。

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S.

在其专业领域，Amneal拥有不断增长的品牌药物组合，主要集中在中枢神经系统和内分泌疾病，并有一条专注于未满足需求的管道。通过其AvKARE分部，该公司是美国药品和其他产品的分销商。

federal government, retail, and institutional markets. For more information, please visit www.amneal.com..

联邦政府、零售和机构市场。有关更多信息，请访问www.amneal.com。。

Cautionary Statement on Forward-Looking Statements

关于前瞻性声明的警示声明

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements.

本文中包含的关于非历史事实的某些陈述可能是前瞻性陈述（定义见1995年《美国私人证券诉讼改革法案》）。此类前瞻性陈述包括有关管理层意图、计划、信念、期望、财务结果或未来预测的陈述，其中包括：对未来运营的讨论；预期或估计的经营成果和财务业绩；以及关于我们定位的声明，包括我们推动可持续长期增长的能力，以及其他非历史性声明。

Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements..

诸如“计划”、“预期”、“将”、“预期”、“估计”等词语以及类似词语或其否定词旨在识别估计和前瞻性陈述。。

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events.

提醒读者不要依赖这些前瞻性陈述。这些前瞻性陈述基于对未来事件的当前预期，包括未来市场状况、公司业绩和财务业绩、运营投资、业务前景、新战略和增长举措、竞争环境和其他事件。

If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company..

如果基础假设不准确或已知或未知的风险或不确定性出现，实际结果可能与公司的预期和预测有很大差异。。

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S.

此类风险和不确定性包括但不限于：我们及时成功开发、许可、获取和商业化新产品的能力；我们在制药行业面临来自品牌和仿制药公司的竞争，以及这种竞争对我们定价能力的影响；我们获得产品独家营销权的能力；我们的收入来自有限数量产品的销售，其中很大一部分是通过有限数量的客户获得的；供应链中长期业务中断的影响；某些客户群的持续整合趋势；我们对第三方供应商和分销商的产品原材料和某些制成品的依赖；我们的品牌竞争对手在法律、监管和立法方面的努力，以阻止我们的通用替代品的竞争；我们对信息技术系统和基础设施的依赖以及网络安全事件的可能性；我们吸引、雇佣和留住高技能人才的能力；与联邦法规有关的品牌和仿制药制造商之间安排的风险；我们不时依赖专有技术的某些许可证；我们在研究和开发上花费的大量资源；第三方对我们提出索赔的风险；与监管环境变化相关的风险，包括美国。

federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authoritie.

与医疗欺诈滥用和健康信息隐私和安全相关的联邦和州法律以及此类法律的变更；食品和药物管理局产品批准要求的变更；医疗改革的影响以及政府当局在覆盖率和报销水平方面的变化。