Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)

The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:
Is the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations/guidelines of sodium acetate in daily PN, which are required to prevent/treat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.
Included Participants:
All the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.
Participants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents/legal representatives (according to local regulations) before the initiation of PN. Gestational age < 33 weeks Included in the study before 72 hours of life

开始日期2024-07-10

申办/合作机构

AGA Khan University Hospital

CTR20241621

/ Recruiting临床1/2期

镓[68Ga]-NYM032注射液在健康受试者、前列腺癌患者体内的药代动力学、生物分布、辐射剂量和安全性研究

Ⅰa期主要目的：评估68Ga-NYM032注射液在健康受试者体内的安全性和辐射安全性。次要目的： 1、评价不同剂量68Ga-NYM032注射液在健康受试者体内的药代动力学； 2、评价不同剂量68Ga-NYM032注射液在健康受试者体内的生物分布； 3、评价不同剂量68Ga-NYM032注射液在健康受试者体内的图像质量。 Ⅰb/Ⅱa期主要目的：评估68Ga-NYM032注射液在前列腺癌患者体内的安全性和辐射安全性。次要目的： 1、评价68Ga-NYM032注射液在前列腺癌患者体内的药代动力学； 2、评价68Ga-NYM032注射液在前列腺癌患者体内的生物分布； 3、评价68Ga-NYM032注射液在前列腺癌患者体内的图像质量； 4、评价68Ga-NYM032注射液在前列腺癌患者体内的诊断效能； 5、评价不同阅片间和同一阅片者内68Ga-NYM032注射液在前列腺癌患者体内的诊断一致性。

开始日期2024-06-04

申办/合作机构

无锡诺宇医药科技有限公司

NCT06354088

/ Recruiting临床1期IIT

Human Models of Selective Insulin Resistance: Alpelisib, Part I

The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.

开始日期2024-04-24

申办/合作机构

National Institute of Diabetes & Digestive & Kidney Diseases

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100 项与醋酸钠相关的临床结果

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100 项与醋酸钠相关的转化医学

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100 项与醋酸钠相关的专利（医药）

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项与醋酸钠相关的文献（医药）

2025-12-31·mAbs

Predicting purification process fit of monoclonal antibodies using machine learning

Article

作者: Cha, Minjeong ; Cuellar, Carlos ; Wang, Amy ; O’Connor, Kelly ; Ott, Nicole ; Kim, Soo ; Rajan, Neeraja Sundar ; Williams, Ambrose ; Sengupta, Rituparna ; Maier, Andrew ; Burgess, Sean ; Neyyan, Josephine

In early-stage development of therapeutic monoclonal antibodies, assessment of the viability and ease of their purification typically requires extensive experimentation. However, the work required for upstream protein expression and downstream purification development often conflicts with timeline pressures and material constraints, limiting the number of molecules and process conditions that can reasonably be assessed. Recently, high-throughput batch-binding screen data along with improved molecular descriptors have enabled development of robust quantitative structure-property relationship (QSPR) models that predict monoclonal antibody chromatographic binding behavior from the amino acid sequence. Here, we describe a QSPR strategy for in silico monoclonal antibody purification process fit assessment. Principal Component Analysis is applied to extract a one-dimensional basis for comparison of molecular chromatographic binding behavior from multi-dimensional high-throughput batch-binding screen data. Kernel Ridge Regression is used to predict the first principal component for new molecular sequences. This workflow is demonstrated with a set of 97 monoclonal antibodies for five chromatography resins in two salt types across a range of pH and salt concentrations. Model development benchmarks four descriptor sets from biophysical structural models and protein language models. The investigation illustrates the value QSPR models can provide to purification process fit assessment, and selection of resins and operating conditions from sequence alone.

2025-12-31·Green Chemistry Letters and Reviews

Treatment of industrial dye effluent: a pre-pilot plant scale study based on circular liquid–liquid extraction using pseudoprotic ionic liquids

作者: Govindaraj, Jegan ; Gardas, Ramesh L. ; Padinhattath, Sachind Prabha

The hazardous chems. discharged from various dyeing industries adversely impact human health and the environment.Therefore, it is essential to treat wastewater containing dyes with technol. that outperforms conventional methods.In the current study, liquid-liquid extraction (LLE) based on pseudoprotic ionic liquids (PPILs) was employed as an efficient tool to remove anionic dyes from simulated and real dye effluent.PPIL derived from trioctylamine and octanoic acid was used for the extraction studies.Initially, simulated dye samples were prepared using different anionic dyes, namely alizarin yellow, rose Bengal, and methyl orange, identical to the real industrial dye effluent composition, and LLE studies were carried out.After a series of screenings, the essential exptl. parameters required for deploying a pre-pilot plant scale study have been optimized systematically.After successful optimization, similar exptl. parameters were deployed for the removal of dyes from the industrial dye effluent collected from Angeripalayam common effluent treatment plant limited (ACETP), Tirupur, Tamil Nadu, India.While most optimized reaction conditions remained unaltered, adjustments were made to some, such as pH, to suit practical scenarios.Moreover, the dyes were back-extracted with dilute diethylamine and the regenerated extractant was reused in subsequent LLE cycles.

2025-12-01·Nano-Micro Letters

3D Printing of Tough Hydrogel Scaffolds with Functional Surface Structures for Tissue Regeneration

Article

作者: Chen, Yuewei ; Hong, Gaoying ; Yuan, Ximin ; Kong, Weicheng ; He, Yong ; Liu, Nian ; Yao, Ke ; He, Jing ; Zhou, Yanyan ; Xia, Pengcheng ; Li, Yuanrong ; Hu, Zihe ; Xie, Zhijian ; Shi, Jue

Abstract:

Hydrogel scaffolds have numerous potential applications in the tissue engineering field. However, tough hydrogel scaffolds implanted in vivo are seldom reported because it is difficult to balance biocompatibility and high mechanical properties. Inspired by Chinese ramen, we propose a universal fabricating method (printing-P, training-T, cross-linking-C, PTC & PCT) for tough hydrogel scaffolds to fill this gap. First, 3D printing fabricates a hydrogel scaffold with desired structures (P). Then, the scaffold could have extraordinarily high mechanical properties and functional surface structure by cycle mechanical training with salting-out assistance (T). Finally, the training results are fixed by photo-cross-linking processing (C). The tough gelatin hydrogel scaffolds exhibit excellent tensile strength of 6.66 MPa (622-fold untreated) and have excellent biocompatibility. Furthermore, this scaffold possesses functional surface structures from nanometer to micron to millimeter, which can efficiently induce directional cell growth. Interestingly, this strategy can produce bionic human tissue with mechanical properties of 10 kPa-10 MPa by changing the type of salt, and many hydrogels, such as gelatin and silk, could be improved with PTC or PCT strategies. Animal experiments show that this scaffold can effectively promote the new generation of muscle fibers, blood vessels, and nerves within 4 weeks, prompting the rapid regeneration of large-volume muscle loss injuries.

项与醋酸钠相关的新闻（医药）

2025-05-12

·药事纵横

多肽纯化中针对多一个色氨酸（Trp）杂质的流动相优化理论

在多肽纯化过程中，含有额外色氨酸（Trp）的杂质（如插入肽或序列错误产物）因其与目标多肽的疏水性、电荷状态及紫外吸收特性差异，常需通过流动相参数的精准调控实现高效分离。以下从理论层面阐述针对此类杂质的流动相设计策略：一、色氨酸杂质的特性与分离挑战疏水性增强色氨酸的吲哚环使其成为疏水性最强的天然氨基酸之一。若杂质较目标多肽多一个Trp，其整体疏水性显著提高，在反相色谱（RP-HPLC）中保留时间通常延长。例如，目标多肽含1个Trp，而杂质含2个Trp时，两者的疏水差异可通过乙腈梯度放大。紫外吸收特性Trp的吲哚环在280 nm处有强紫外吸收峰，而其他氨基酸（如甘氨酸、丙氨酸）在此波长吸收较弱。利用此特性，可通过调整流动相的紫外截止波长（如选择乙腈而非甲醇）避免背景干扰，并增强杂质检测灵敏度。电荷分布差异Trp的极性吲哚环在特定pH下可能参与氢键或偶极相互作用。例如，当流动相pH接近目标多肽等电点（pI）时，杂质的额外Trp可能通过侧链极性基团改变多肽整体电荷分布，从而影响其与固定相的静电作用。二、流动相关键参数的调控机制1.pH值的优化· 电荷差异放大：调节流动相pH至目标多肽的pI附近（如pH 5-7），可抑制目标多肽的电离，使其疏水性占主导；而含额外Trp的杂质可能因电荷差异（如邻近酸性/碱性氨基酸）偏离pI，导致保留行为显著不同。例如，某多肽pI为5.5，含额外Trp的杂质因邻近谷氨酸（Glu）使其pI降低至4.8，此时采用pH 5.5的流动相可增强疏水分离。Trp微环境影响：Trp的吲哚环在酸性条件下（pH <6）质子化倾向增强，可能通过疏水-π相互作用与固定相结合更紧密；而在中性pH下，其极性基团暴露，疏水性相对降低。需通过实验梯度测试确定最佳pH窗口。2.有机溶剂类型与梯度设计乙腈与甲醇的选择：乙腈因洗脱能力强、黏度低，是分离疏水性差异显著体系的首选。对于含多个Trp的杂质，初始低乙腈比例（如20%-30%）可延长目标多肽与杂质保留时间的差异，而梯度斜率（如0.5%-1.0%/min）需根据疏水差异动态调整。若杂质保留过强，可采用甲醇替代部分乙腈以调节极性差异。梯度分段策略：例如，在纯化含Trp的抗菌肽时，采用两段梯度：20%-40%乙腈（10分钟）洗脱目标多肽，40%-60%乙腈（15分钟）洗脱含额外Trp的疏水杂质，可提升分离度至1.5以上。3.离子对试剂与添加剂三氟乙酸（TFA）的作用：0.1% TFA作为离子对试剂，可与多肽的氨基形成离子对，增强疏水保留。对于含额外Trp的杂质，TFA浓度可提高至0.15%以进一步放大疏水差异。例如，某案例中TFA浓度从0.1%增至0.15%，目标峰与杂质峰的分离度从1.2提升至2.0。抗氧化保护：若Trp位于易氧化位点（如邻近半胱氨酸），需添加1-5 mM DTT或TCEP防止吲哚环氧化，避免生成羟基化副产物干扰检测。4.缓冲盐与离子强度醋酸体系的选择：醋酸缓冲液（pH 3-5）可稳定Trp的吲哚环结构，同时通过调节离子强度（如50-200 mM）抑制非特异性吸附。例如，醋酸钠浓度从50 mM增至150 mM时，含Trp杂质的峰宽减少30%，分离效率提升。三、色谱柱与检测条件的匹配固定相选择：疏水性填料：C18柱适用于高疏水性杂质分离，而苯基柱可通过π-π相互作用增强对Trp的选择性。·粒径与孔径：小粒径（3-5 μm）填料可提高分离度，大孔径（300 Å）色谱柱适应含Trp多肽的构象变化。检测波长优化：选择214 nm（肽键吸收）与280 nm（Trp特征吸收）双波长检测，可同时监控目标多肽与杂质。例如，在280 nm下，含额外Trp的杂质峰面积较目标多肽高2-3倍，便于定量分析。四、应用实例与优化路径案例：GLP-1类似物中Trp插入杂质的去除背景：目标多肽含1个Trp，粗品中混入含2个Trp的插入肽（纯度85%）。方案：流动相：pH 5.0醋酸缓冲液 + 0.15% TFA，乙腈梯度从25%升至50%（梯度斜率0.8%/min）。1.色谱柱：Luna C18（5 μm, 300 Å），柱温30℃降低黏度。2.结果：主峰保留时间8.2分钟，杂质峰10.5分钟，纯度提升至98.5%，分离度达2.3。五、总结与展望针对含额外Trp的杂质，流动相优化的核心在于通过pH调控电荷分布、梯度设计放大疏水差异、离子对试剂增强选择性。未来可结合分子动力学模拟预测Trp与固定相的相互作用模式，并开发智能梯度系统实时优化分离条件。此外，绿色溶剂（如超临界CO₂）替代乙腈的研究，为降低环境负荷提供了新方向。药事纵横投稿须知：稿费已上调，欢迎投稿

临床结果

2024-08-26

·CPHI制药在线

会议报名 | 东南亚医药市场开拓机遇与挑战主题会议

✦ ✦ ✦ 随着中国经济的快速增长和科技实力的提升，国内新药研发蓬勃发展，为出海打下良好基础。一直以来，中国医药、原料药出口贸易在东南亚市场占有举足轻重的份额。其中，印度尼西亚、泰国、越南、菲律宾和马来西亚五个国家占据了东南亚医药市场的90%以上。未来这些国家将会成为国内企业转战的重要市场，包括投资建厂等深度合作开发。为助力中国药企加速布局东南亚医药市场，9月11日，东南亚医药市场开拓机遇与挑战主题会议将于CPHI & PMEC 制药工业展（深圳）展会期间在深圳会展中心（福田）举办。会议将从当下市场的最新国际形势出发，结合案例与报告，与上下游企业共同探讨东南亚市场的发展机遇。 ✦ ✦ ✦ 东南亚医药市场开拓机遇与挑战主题会议会议时间 9月11日会议地点深圳会展中心（福田）论坛区A（展位：9A56）主办单位上海博华国际展览有限公司承办单位北京东方比特科技有限公司协办单位 E药经理人扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份 SHENZHEN 会议议程 09:30 主持人致辞 09:40-10:20 东南亚国家医药国际贸易报告嘉宾介绍吴惠芳北京东方比特（健康网）总经理兼首席研究员，北京玉德未来控股有限公司副总裁吴女士在军事医学科学院药物分析专业获理学硕士学位，1980年起从事药学相关工作，2000年前在部队医疗、科研机构从事临床药学、科研管理等工作，技术职务副主任药师。2000年退役后从事医药信息研究工作，专注于医药行业研究、市场研究、产业链结构研究等领域。在医药原料药、医药商品进出口、医药产业数据等信息方面有发布了大量文献资料和报告发表。为国内外企业、政府和科研机构提供咨询服务。连续多年为“中国化学制药工业协会”所著《医药发展蓝皮书》、《中国医药手册》作者之一；是《中国医药报》、《医药经济报》的特约撰稿人，在国内重要医药报刊发表大量文章。多次被邀请在中国医药行业大型会议和展览上做有关中国医药市场专题演讲。她的演讲以实际数据和案例阐明问题、总结变化规律，在中国制药企业中广为流传，受到医药界的好评。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:20-10:50 中国制药企业出海东南亚国家的案例分享嘉宾介绍王亚锋上海医药国际业务事业部东南亚区域负责人、上药泰国总经理中国药科大学本科，中欧国际工商学院Global EMBA。从事医药国际营销工作十余年，深厚的医药行业知识和专业能力。拥有丰富的海外子公司运营和营销团队管理经验。深度参与海外工厂立项，写字楼，仓库等绿地项目建设。海外常驻包括非洲加纳，尼日利亚，乌干达，科特迪瓦，东南亚泰国，菲律宾等多个国家。熟悉多个市场药政法规以及行业准入要求。多次在海外国家从零开始设立全资公司、合资公司，组建销售团队，实现业绩从零突破，运作药品进入国家用药指南和国家医保。所在团队曾实现单品种中国制剂出口第一。历任复星医药集团桂林南药国际商务代表，销售经理，海外国家经理，大区经理等，现任上海医药国际业务事业部东南亚区域负责人，上药泰国总经理。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:50-11:20 印度尼西亚制药业的机遇和市场开拓实践嘉宾介绍张君丽成都市一诺医药化工有限公司总经理采购总监公司团队深耕印尼市场十年，专注医药API等产品出口；聘请多名印尼本地员工，长期穿梭在印尼各个制剂工厂，拜访客户，与当地前十大药企均有超级深度的合作与链接！ 11:20-11:45 印尼清真医药产品市场情况更新嘉宾介绍 Dr. Ir. Muslich, M.Si Halal Partnership and Audit Services Director, LPPOM 获得IPB大学学士(S1)、研究生(S2)和博士(S3)学位;此前曾在多家私营公司工作(1991年至1993年)，PT TELKOM WITEL IX Jayapura农业和农用工业发展中心经理(1993年至1994年)，LPPOM MUI清真保证体系负责人(2010年至2015年)，QA和LPPOM MUI标准负责人(2015年至2019年)，LPPOM MUI高级顾问(2020年)，MUI清真认证要求开发团队负责人(2010年至2011年);现为IPB大学农业技术学院农业工业工程系讲师(自1994年起)，清真审核员(自1995年起)，清真管理体系标准制定技术委员会(SNI 99 001)成员，清真家禽屠宰场(SNI 99 002)，家庭切清真反刍(SNI 99 003)，清真食品(SNI 99 004)国家标准化机构(自2015年起)，SKKNI主管能力测试设备开发团队负责人Halal & SKKNI清真审核员(自2017年起)，国家认证机构能力评估员职业(BNSP)(自2015年起)，食品安全能力评估员，机构专业认证(LSP)食品质量保证与安全(JMKP)(自2015年起);于2020-2022年被任命为LPPOM MUI清真合作与审计服务总监。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 11:20-12:00 圆桌讨论：寻找东南亚市场的机会讨论嘉宾深圳市远邦医药有限公司湖南尔康制药股份有限公司成都倍特药业有限公司广州康臣药业有限公司 ...... 扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份把握东南亚市场发展机遇加速融入全球制药供应链随着东南亚医药市场的发展潜能进一步释放，中国医药企业将迎来更多发展机遇。作为中国药企链接国际市场的重要纽带，CPHI & PMEC 制药工业展（深圳）将携手400余家优质展商，共同探索企业在东南亚乃至全球市场的发展路径。下面就请跟随小编的步伐，一起走近本期的优选展商吧！浙江瑞邦药业股份有限公司展位：9F08 浙江瑞邦药业股份有限公司成立于1956年，具有60多年生产医药原料药和食品添加剂的生产经验。公司以药品生产质量管理规范（GMP) 标准组织生产和销售。本公司的产品获得了美国FDA，欧洲CEP和中国GMP的认证。主要产品有葡萄糖酸盐系列，莫匹罗星，莫匹罗星钙，环孢菌素，夫西地酸等。浙江瑞邦药业股份有限公司在国内外都享有良好的声誉。产品远销美国，欧洲，日本，印度及其他南美和东南亚地区。主推产品环孢菌素、莫匹罗星、莫匹罗星钙、葡萄糖酸钙、葡萄糖酸锌、葡萄糖酸钾、葡萄糖酸镁、葡萄糖酸亚铁、葡萄糖酸铜、葡萄糖酸锰、葡萄糖酸钠、多粘菌素B、夫西地酸、夫西地酸钠、米尔贝肟、葡萄糖酸内酯、非达霉素、甘草次酸、原儿茶酸。 ☝🏿☝🏿上下滑动查看完整展商介绍河北华晨药业集团有限公司展位：9D46 河北华晨药业集团有限公司，始建于1991年，坐落于黄骅经济开发区。是一家集研发、生产、销售药用包装材料、原料药、制剂、医疗器械，开展国内外贸易为一体的医药企业。集团公司现下设河北华晨药业有限公司、黄骅华宾生物科技有限公司、河北华迪药业有限公司、华晨吉海（北京）药物研究院。目前华晨药业拥有通过GMP认证的药用氯化钠、碳酸氢钠、氯化钾及新增制剂包括片剂、硬胶囊制剂、颗粒剂、散剂、软膏剂、凝胶贴膏剂、口服液等数十种，同时生产药用PE袋、膜、包装桶、瓶等药用包装材料等。主推产品氯化钠、碳酸氢钠、氯化钾、氯化钙、氯化铵、依地酸二钠、重酒石酸胆碱、富马酸（辅料、富马酸亚铁、醋酸钙、醋酸钠、硫酸镁、碘化钾、氯化镁、富马酸亚铁、葡萄糖酸锌、葡萄糖二酸钙、双乙酸钠、树脂再生剂、碳酸镧、硫酸钾、利多卡因、氟比洛芬、氯化镁、麝香草粉、盐酸利多卡因、葡萄糖酸钙、洛索洛芬钠、磷酸奥司他韦、无水硫酸钠、氨苯蝶啶、托匹司特、硫酸亚铁、西甲硅油、硫酸双肼屈嗪、甘羟鋁、葡萄糖酸亚铁、叔丁醇镁、异丙醇镁、二甲硅油、碳酸钙、亚硫酸镁（六水）、硫酸钾、乳酸钙、乳酸钠、乳果糖、丙胺卡因、喷托维林、丁卡因、双氯芬酸依泊胺、克立硼罗、阿达帕林、盐酸异丙嗪、高岭土、克罗米通、盐酸异丙嗪、氨苯蝶啶、叔丁醇镁、异丙醇镁、亚硫酸镁知名。 ☝🏿☝🏿上下滑动查看完整展商介绍山西阳和药业有限公司展位号：9A13 山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。主推产品乙酰半胱氨酸、间苯三酚、聚乙烯醇、间苯三酚三甲醚。 ☝🏿☝🏿上下滑动查看完整展商介绍浙江荣耀生物科技股份有限公司展位：9C51 浙江荣耀生物科技股份有限公司创立于1999年，位于台州湾经济技术开发区，是一家集研发、生产、销售于一体的创新型医药企业，是国家高新技术企业、浙江省专精特新中小企业、浙江省科技型中小企业。业务涵盖医药原料药及中间体、兽药原料药及中间体、CDMO等。主推产品二硝托胺148-01-6、甲砜霉素15318-45-3、氟苯尼考73231-34-2、非班太尔58306-30-2、芬苯达唑43210-67-9、莫昔克丁113507-06-5、赛拉菌素220119-17-5、氟雷拉纳864731-61-3、奥拉替尼1208319-26-9、2-氨基-N-(2、2、2-三氟乙基)乙酰胺盐酸盐1171331-39-7、三氯苯达唑68786-66-3、癸氧喹酯18507-89-6、尼卡巴嗪330-95-0、3′、5′-二氯-2、2、2-三氟苯乙酮130336-16-2、4-氯吡咯并嘧啶3680-69-1、反式-N-甲基-[4-(甲氨基)环己基]甲磺酰胺1809995-95-6、依帕司他82159-09-9、盐酸氨溴索23828-92-4、盐酸金刚乙胺1501-84-4、盐酸溴己新611-75-6、西司他丁82009-34-5、3-甲基-6-硝基-1H-吲唑6494-19-5、2-[4-(2-吡啶基)苄基]-肼羧酸叔丁酯198904-85-7、2-氨基-1-(2、5-二甲氧基苯基)乙醇3600-87-1、3-(三氟甲基)-5、6、7、8-四氢-[1、2、4]三唑并[4、3-a]吡嗪盐酸盐762240-92-6、(3S、4R)-4-(4-氟苯基)-1-甲基-3-哌啶甲醇105812-81-5、1-(4-氨基苯基)环戊甲腈115279-73-7、3-氨基-1-金刚烷醇702-82-9、1-金刚烷甲酸828-51-3、2-金刚烷酮700-58-3、1-金刚烷胺768-94-5、1-金刚烷甲醇770-71-8、2-金刚烷醇700-57-2、1-金刚烷醇768-95-6。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏宇田医药有限公司展位：9E31 江苏宇田医药有限公司是一家从事现代医药研发、生产、销售为一体的新型特色API及CDMO制药企业，致力于为国内各大制药企业提供高质量的原料药与中间体，公司产品同时远销欧洲、日韩、印度等数十个国家，为国家重点高新技术企业、市科技小巨人企业、中华药港新医药产业基地骨干企业之一。宇田医药始终把科研开发作为企业可持续发展的支撑力量，是国内科研投入较多的药企之一，公司以连云港研发中心为科研载体，配合杭州科巢生物科技、连云港万科生物科技、黑龙江迪诺医药，自主创新能力不断增强。形成了“以一带三”的良性格局。宇田医药在江苏连云港、黑龙江佳木斯建有两个生产基地，获得国家高新技术企业、省级工程技术研究中心、江苏省瞪羚企业、江苏省科技型中小企业、安全标准化二级企业、省两化融合示范试点企业，同时也获得了原料药品种的GMP和注册现场核查的二合一认证，先后承担省/市级成果转换等多个省/市级科技项目；获得授权专利与商标数十项；通过ISO9000、ISO14000认证。这些荣誉的取得标志着企业药品生产质量和管理水平走在了全国医药行业前列。主推产品原料药：碘克沙醇、碘海醇、阿托伐他汀钙、瑞舒伐他汀钙、盐酸伊伐布雷定、利奈唑胺、西洛多辛、盐酸厄洛替尼、盐酸莫西沙星及各中间体。中间体：造影剂系列中间体、多尼培南侧链、比阿培南侧链、1,4-丁二磺酸。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏同禾药业有限公司展位：9D26 江苏同禾药业有限公司是江苏万兴创业投资有限公司的全资子公司，是一家集制剂药、原料药和保健食品的研发、生产、销售为一体的国家高新技术企业。连续8年，跻身于常熟市百强企业前50 名。公司拥有原料药、片剂、胶囊剂和颗粒剂的GMP证书。硫辛酸、6.8-二氯辛酸乙酯、右旋硫辛酸钠、环丙贝特、10-甲氧基亚氨基芪等多个产品被评为江苏省高新技术产品；硫辛酸、盐酸二甲双胍等取得了原料药品批件，厄多司坦片、氨酚伪麻分散片和新雪胶囊等取得药品注册批件和新药证书；硫辛酸片和胶囊即将取得新药证书，另有10多个新药正在SFDA审批中。调节血糖和控制并发症的保健食品唐苹片正在全国热销中。主推产品硫辛酸系列、右旋硫辛酸、右旋硫辛酸钠盐、右旋硫辛酸氨基丁三醇盐。 ☝🏿☝🏿上下滑动查看完整展商介绍 CPHI & PMEC 制药工业展（深圳）致力于打造国际化制药产业生态圈，汇集产业链上下游实力企业，以技术驱动产业提升，助推更多中国药企扬帆“出海”，聚势共赢！扫描二维码 0元领票 8月30日前完成预登记现场可领取电子会刊一份金秋九月·不见不散！联系我们参观咨询林女士电话：021-33392105 邮箱：ashley.lin@imsinoexpo.com 张女士电话：010-58036315 邮箱：zhangyuanyuan@cccmhpie.org.cn 参展咨询茅女士电话：021-33392250 邮箱：chris.mao@imsinoexpo.com 吴女士电话：010-58036296 邮箱：wuyushuang@cccmhpie.org.cn 👇点击“阅读原文”，免费领取展会参观门票！！

高管变更

2024-01-09

·Business Wire

A.forall Announces Launch of a Generic Version of Sodium Acetate Injection 4 mEq/mL

MINNETONKA, Minn.--( BUSINESS WIRE )-- Milla Pharmaceuticals Inc., an A.forall company, announced that its partner, Woodward Pharma Services LLC , has just commercialized its Supplemental Abbreviated New Drug Application (sANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Sodium Acetate Injection 4 mEq/mL marketed by Fresenius Kabi USA LLC. Sodium Acetate Injection 4 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also used as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic drug product, Sodium Acetate Injection, 2 mEq/mL, by the FDA in 2021, which has been commercialized since July 2021. The newly launched 4 mEq/mL is a more concentrated version marketed by Fresenius Kabi USA LLC. The approval of this Supplemental Abbreviated New Drug Application (sANDA), which occurred under priority review from the FDA because of its shortage status, has been consistent with A.forall’s last two FDA filings which were First Cycle Review Approvals. The Sodium Acetate Injection 4 mEq/mL has been consistently listed on the FDA Drug Shortages List for the last several years. “Our joint mission of making affordable medicines available to all is more then ever at the centre of what we do every day,” commented Filip Van de Vliet, CEO of A.forall. “With this sANDA, an alternative concentration of the Sodium Acetate Injection we launched two years ago, we again substantially increase the availability of a life-saving drug that U.S. patients would otherwise be lacking. Once again, the strength of our product development and regulatory teams has allowed us to bring a fast and high-quality solution to those in need.” About A.forall We Make Affordable Medicines Available To All: we develop value-added generic pharmaceuticals, solve product shortages and fill unmet medical needs so that patients can continue their treatment. At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world. More info: About – A.forall About Milla Pharmaceuticals Milla Pharmaceuticals Inc., an A.forall company, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics. More info: About - Milla Pharmaceuticals About Woodward Pharma Services LLC Woodward Pharma Services LLC is a specialty pharmaceutical company focused on acquiring, licensing, and commercializing branded and generic prescription drugs for the U.S. Market. Woodward has a diverse portfolio of products distributed across multiple channels. More info: Who We Are — Woodward Pharma Services LLC

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