Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic medicines in

Breckenridge Pharmaceutical, Inc.，东和国际的美国子公司，在市场、分销和销售通用药品方面扮演角色。

, announced today that the Food and Drug Administration (FDA) has granted approval of its Dehydrated Alcohol Injection, USP, 5 mL of ≥ 99% by volume ethyl alcohol Single-Dose Vials, a generic version of Ablysinol® by Belcher Pharmaceuticals, LLC, developed in partnership with Andersen Pharma Global..

，今天宣布食品药品监督管理局（FDA）已批准其脱水酒精注射液，USP，5毫升≥99%体积比的乙醇单剂量小瓶，这是Belcher Pharmaceuticals公司开发的Ablysinol®的仿制药版本，与Andersen Pharma Global合作开发。

Dehydrated alcohol injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients and meets the quality and purity standards set by the United States Pharmacopeia (USP). It is indicated for the induction of controlled cardiac septal infarction to improve exercise capacity in adult patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who are not suitable candidates for surgical myectomy.

无水酒精注射液是一种无菌、不含防腐剂的溶液，乙醇体积含量≥99%，不含任何辅料，并符合美国药典（USP）规定的质量和纯度标准。它适用于通过诱导可控的心脏室间隔梗死来改善症状性肥厚型梗阻性心肌病（HOCM）成年患者的运动能力，这些患者不适合接受外科心肌切除术。

Dehydrated Alcohol Injection, USP, will be available primarily in hospitals, clinics, and home health care facilities..

脱水酒精注射液，USP，将主要在医院、诊所和家庭保健机构提供。

President and Chief Commercial Officer of Breckenridge Pharmaceutical

布雷肯里奇制药公司总裁兼首席商务官

'The approval and launch of our Dehydrated Alcohol Injection, USP, is a significant achievement, positioning Breckenridge as one of the first companies in the U.S. market to offer a generic alternative to Ablysinol®.

“我们的无水酒精注射液（USP）获批并上市是一项重要成就，这使布雷肯里奇成为美国市场率先提供Ablysinol®仿制药替代品的公司之一。”

This milestone reflects our continued dedication to providing affordable treatment options that meet real patient needs and reinforces our commitment to serving the institutional channel.

这一里程碑反映了我们持续致力于提供满足患者实际需求的可负担治疗选择，并重申了我们对服务机构渠道的承诺。

This launch is a key milestone in

此次发射是

Breckenridge's strategic plan

布雷肯里奇的战略计划

, aligning with the company's short- and mid-term objectives to expand its presence in the institutional healthcare channel and strengthen its diversified portfolio. By introducing a wide range of oncology, autoimmune, rare disease, and supportive care products to the U.S. market, Breckenridge reaffirms its commitment to enhancing patient access to medicines and providing more therapeutic solutions to meet their needs.

，与公司短期和中期目标相一致，即扩大其在机构医疗渠道的存在并加强其多元化产品组合。通过向美国市场引入广泛的肿瘤学、自身免疫、罕见病及支持性护理产品，布雷肯里奇再次确认了其致力于提高患者获得药物的机会，并提供更多的治疗方案以满足他们的需求。

The approval also aligns with .

该批准也与之相符。

Towa International's global mission

Towa国际的全球使命

of contributing to people's health by increasing access to high-quality, affordable therapeutic solutions across the world.

为世界各地的人们提供高质量、可负担的治疗方案，从而为人们的健康做出贡献。

Breckenridge remains committed to working closely with healthcare professionals and institutional partners to ensure the availability of Dehydrated Alcohol Injection, USP, and to support the appropriate use of this treatment option.

布雷肯里奇仍致力于与医疗保健专业人员和机构合作伙伴密切合作，以确保脱水酒精注射液（USP）的可用性，并支持这种治疗选择的适当使用。

About Breckenridge Pharmaceutical, Inc.:

关于Breckenridge Pharmaceutical, Inc.

Breckenridge Pharmaceutical, Inc.

布雷肯里奇制药公司，

New Jersey

新泽西州

), the U.S. subsidiary of Towa International (

），东和国际（Towa International）的美国子公司（

Barcelona, Spain

西班牙巴塞罗那

), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve..

），与全国及世界各地的制造商合作，为美国患者提供高质量、低成本的仿制药。我们致力于客户服务、准时交付、可靠供应和优质生产，努力为我们及我们的客户所服务的患者健康带来积极影响。

About Andersen Pharma Global:

关于安徒生制药全球：

The development partner for this product, Andersen Pharma Global, is a U.S.-focused company specializing in the identification, development, manufacturing, and supply of pharmaceutical products. With a strong track record of delivering affordable medicines and ensuring consistent supply, Andersen Pharma continues to play a vital role in improving patient access to essential therapies..

该产品的开发合作伙伴安德森制药全球公司是一家专注于美国的公司，专业从事药品的鉴定、开发、生产和供应。安德森制药有着提供价格合理的药品并确保持续供应的良好记录，继续在改善患者获得必要治疗方面发挥着至关重要的作用。