American Regent, Inc.

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

盐酸尼卡地平注射液从立项到FDA获批用时45个月，从获批到首批出口美国仅13天，背后其实是苑东生物国际化的十年长征路。 时间来到2024年，中国药企正在通过高价值产品抢占国际市场。 本月初（9月10日），苑东生物发布公告，其第二个美国注册品种盐酸尼卡地平注射液于9月6日获得FDA注册批准，即将出口美国。 这不仅代表苑东生物的国际化“三步走”战略有了实质性突破，还是一份来自中国医药企业，如何通过多年原料药优势积累，攻克核心技术，以仿创结合的方式走向国际的可互鉴样本。 苑东生物用盐酸尼卡地平注射液从立项到获批的45个月与从获批到首批出货的13天，屡获里程碑的经验回答了几个问题：中国仿制药企如何脚踏实地式创新？如何坚守产品质量标准？以及不畏浮云，在十余年间保持初心，最终收获果实？ 01 以“差异化”先手棋，奠定国际化底蕴 通常来讲，一款产品的市场宽度与广度，奠定了其未来商业化收入的基础，而产品的差异化水平，则决定了未来市场空间的深度与高度。 苑东生物的盐酸尼卡地平注射液就是这样一款兼具市场厚度与广阔潜力的“价值”产品。上市多年的前人构建起了较为完善的市场渠道和客户关系，市场规模逐年稳步增长，使得这一产品起步便“站在巨人的肩膀上”；而背靠苑东生物多年积累的质量管理体系与原料药优势，再叠加其独特制剂技术，又使其成为一匹“黑马”，为市场注入了新的动能。 具体而言，盐酸尼卡地平注射液在临床上被用于无法口服给药时的高血压短期治疗，并且具有不可替代的作用。不仅如此，近年来，随着老龄化加剧与高血压疾病的高发，盐酸尼卡地平注射液市场需求更是长期保持稳定增长。有公开数据显示，美国20岁以上人群的高血压患病率高达47.3%，患者约1.21亿人，并且这一数据还在逐年扩增。 在美国市场上，盐酸尼卡地平注射液自原研产品专利到期后，仿制药市场长期被AMERICAN REGENT INC、WOCKHARDT LTD、EUGIA PHARMA SPECIALITIES LTD等美国本土药企和印度药企占据。虽然这些药企构建了较为成熟的商业化体系，但也因成本与技术未能有效优化改善，造成市场增长固化。 此时，为避开激烈竞争，聚焦注射剂和鼻喷雾剂等高端剂型的苑东生物自然成为一位破局者，通过产品质量、成本控制、制剂工艺等方面的提升，为市场增添新活力。 E药经理人根据公开资料发现，其实早在2006年，苑东生物就开始布局国际化产品研发，在2016年就实现了原料药的国际化。十余年的积累不仅成为苑东生物产品进入美国市场的“底气”，也是其实现差异化竞争的实力所在。 据悉，为保障产品质量，苑东生物对盐酸尼卡地平注射液的原料药和制剂都进行了路线或工艺深度创新。 在产品质量方面，苑东生物的原料药质量标准优于现有美国药典（USP）、中国药典（ChP）、欧洲药典（EP）、日本药典（JP）等主流药典标准； 在原料药工艺方面，苑东生物采用了新的路线，反应选择性更好，杂质清除更有效，放大更简便； 在制剂工艺方面，针对盐酸尼卡地平注射液的溶解度差，热稳定性不佳等特性，苑东生物设计并采用经优化的制剂工艺，可降低制剂生产过程杂质增长的风险，保证产品质量。 最终，盐酸尼卡地平注射液不仅被国际知名公司青睐，与苑东建立了销售战略合作关系。 苑东生物研发负责人告诉E药经理人，在盐酸尼卡地平注射液的审评期间，FDA的相关法规进行了更新，新增了盐酸尼卡地平结构相关亚硝胺杂质研究要求。而苑东生物的研发团队凭借多年经验，在第一时间就制定出各模块统一协作方案，深入研读最新法规，快速制定研究策略，风险评估、文献调研和试验同步推进，仅10余天就完成该问题答复，并最终获得FDA认可。“团队开发了专属性强、灵敏度高的分析方法，解决了40多个潜在致突变杂质和多个亚硝胺杂质的检测难题。” 值得一提的是，距离9月6日，苑东生物盐酸尼卡地平注射液ANDA申请获得美国FDA正式批准，9月19日即实现了首单出口美国，不仅是苑东生物的选品策略的前瞻性体现，更展现了其差异化优势得到市场认可。 02 以“组合拳”关键棋，筑牢发展根基 回溯盐酸尼卡地平注射液的国际化之路，从立项到FDA获批用时45个月，从获批到首批出口美国仅13天。时间上的“快”，以及在应对审评挑战时的“稳”，背后都折射出苑东生物对长期主义的执着追求，以及脚踏实地的战略布局。 事实上，美国市场一直被称为药品定价“高地”，国内大批创新药与仿制药企业纷纷将登陆美国市场视为实现更高产品价值的突破口。然而，更大的市场其实也意味着更激烈的竞争，也就是说，成本控制和制剂技术在美国市场更为重要，“仅靠一台压片机”就想要在美国市场实现放量显然是天方夜谭。 另一方面，在美国市场，产品组合优势也是制药企业竞争实力的体现。 美国仿制药市场的“高定价”来自于其高度市场化的商业模式，一款产品的院内准入，往往需要通过专门的集团采购组织（GPO）来进行，公开数据显示，美国市场约73%的药品采购是由GPO所完成。GPO的主要利润来源则是在采购过程中收取管理费，采购规模越大，利润越高。 所以拥有规模与效率兼具产品组合的制药企业，自然也成为备受GPO青睐的对象，相对应的，也拥有更高的议价空间。因此，拥有差异化技术优势的产品以及品类丰富的产品“矩阵”，就成了中国仿制药企进军美国市场的切入口。 “深耕高壁垒赛道，抢占市场先机，形成组合优势”是苑东生物一直以来的风格，如盐酸尼卡地平注射液这样的高端制剂产品，在苑东生物的布局中不止一例。 据悉，截至目前，以苑东生物最早获得FDA批准的产品盐酸纳美芬注射液“打头阵”，在麻醉镇痛领域，还布局了EP-0112T鼻喷剂、EP-0113T鼻喷剂等高端制剂产品。 苑东生物相关负责人告诉E药经理人，未来，公司将坚持以高端制剂作为国际市场切入口，聚焦麻醉镇痛组合产品，助力创新药国际化。 此外，在原料药方面，苑东生物拥有欧美日等主流市场的国际cGMP认证，其主要产品富马酸比索洛尔、非罗考昔、盐酸纳美芬、盐酸尼卡地平、罗替高汀等已通过欧盟、日本或美国FDA认证，原料药已经销往包括欧美日等主流市场在内的全球40多个国家和地区。 03 以“前瞻性”制胜棋，践行初心承诺 以高质量与核心技术，形成差异化壁垒，以独特产品组合，切入国际化市场，不仅是苑东生物的竞争策略，也是中国药企为人类健康谋福祉的初心与承诺。 事实上，早在盐酸尼卡地平注射液的国际化立项之前，苑东生物在2016年就实现了原料药国际化。据半年报显示，公司已成功实现30个原料药的产业化，15个原料药已完成国际注册/认证，11个原料药已出口主流国际市场。 苑东生物的国际化战略是从原料药国际化，到高端制剂，最后到创新药国际化的“三步走”战略。盐酸尼卡地平注射液以及此前在美国市场获批上市的盐酸纳美芬注射液就标志着苑东生物在高端制剂国际化方面，从“0到1”的突破。 值得一提的是，在推动盐酸尼卡地平注射液和盐酸纳美芬注射液两款产品走向国际的过程中，苑东生物还建立了鼻喷剂等高壁垒复杂制剂工艺开发及分析技术平台，以及标准化的国际注册管理体系。因此这两款产品在美国的获批，也使得苑东生物符合FDA标准的研发体系、质量体系以及国际化人才团队，得到验证。 在这两款产品的基础上，苑东生物的国际化蓝图也已经绘成： 短期内，苑东生物仍将持续推进原料药和高端制剂的国际化。 在高端制剂产品的商业化方面，第一是寻找优秀的合作商，优先两类客户，仿制药销售网络广，能力强的国际大企业，或美国销售代理公司；第二是探索先开发客户再研发上市的新业务模式。 在国际化市场开拓方面，短期以美国市场、中美双报为主，中期将从美国市场拓展到若干重点欧洲市场，长期将择机切入东盟等新兴市场，逐步探索一品多报。 在创新药方面，苑东生物已经有一款1类创新药EP-0146片的临床申请已获得国家药监局承办受理，并申报了在美IND，用于治疗晚期实体瘤。 未来，苑东生物还将通过聚焦于技术壁垒较高，市场需求更大的无菌注射剂和鼻喷剂等药械组合复杂制剂，打造细分领域的优势产品群，建立苑东品牌的国际市场影响力。 剖析美国仿制药市场，早在20多年前，就不乏中国药企登陆，甚至自2018年起每年都有20余款仿制药产品加入ANDA的征程，百亿市值的中国药企手握数十款ANDA批文不在少数。 然而，盘点美国收入最高的仿制药企业，除了梯瓦、晖致、山德士等老牌MNC，榜单中只剩太阳制药、阿拉宾度制药、Dr Reddy's等印度药企，必须要面对的现实是，布局数十年，仍无一家中国药企在美国市场闯出一片天地。 但不可否认的是，每一次中国药企闯关成功，都代表一场具有突破性意义的里程碑，要相信市场需求与创新技术的长尾效应。 追溯我国科学的发展历程，每一场伟大科学成就的诞生都并非一次速度竞赛，而是为了更崇高的目标——服务人类福祉。无论是青蒿素的发现，还是华为芯片的研发，都体现了这一理念。 苑东生物历经十余年的国际化步伐也是如此，就像苑东生物董事长王颖所言：产品的出口不仅仅是为了赚取利润，更重要的是实现我们“以患者为中心，为人类健康沐浴阳光”的使命，将中国的优质产品和品牌文化传播到世界各地，为中国制造和中国品牌争光添彩。 关于苑东生物 成都苑东生物制药股份有限公司是一家以研发创新驱动，集化学原料药、高端化学药及生物药研发、生产、销售于一体的高科技医药上市企业。公司坚持“以患者为中心，为人类健康沐浴阳光”的使命，以全球视野布局产品管线，聚焦麻醉镇痛，兼顾心脑血管、肿瘤、内分泌等重大疾病领域，不断填补临床用药空白，惠及全球患者。公司先后被认定为国家技术创新示范企业、国家企业技术中心、国家知识产权示范企业、国家绿色工厂，多次荣登中国化药企业百强、中国医药创新企业百强等榜单，是国内医药工业创新发展的典型代表之一。 一审| 黄佳 二审| 李芳晨 三审| 李静芝

SHIRLEY, N.Y., July 2, 2024 /PRNewswire/ -- American Regent announces the launch and availability of Sodium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Sodium Phosphates .1 Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Continue Reading Sodium Phosphates Injection, USP is available in three presentations The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. "An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Sodium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. This product is available for immediate shipment. Customers can order Sodium Phosphates Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706. Sodium Phosphates Injection, USP is supplied as follows: See the following Important Safety Information, in addition to the product's Full Prescribing Information. For additional information, please visit FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS INDICATIONS AND USAGE Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. WARNINGS Sodium Phosphates Injection, USP 3 mM P/mL must be diluted and thoroughly mixed before use. To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. PRECAUTIONS Do not administer unless solution is clear and seal is intact. Discard unused portion. Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion. Use with caution in patients with renal impairment, cirrhosis, cardiac failure, and other edematous or sodium-retaining states. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Pregnancy: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children, and adolescents). Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. OVERDOSAGE In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. For additional safety information, please see Full Prescribing Information . You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting or by calling 1-800-FDA-1088. You are encouraged to report adverse drug events (ADEs) to American Regent: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit . About Daiichi Sankyo Group Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: . All trademarks are the property of their respective owners. Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed April 12, 2024 . SOURCE American Regent Inc