Clavulanic Acid

公司介绍广州艾奇西是一家综合医药研发、生产及销售服务的高新技术企业，服务内容包括药物研发CRO服务(创新药和仿制药的药学研究)，创新药和仿制药研发注册申报(中美欧等申报)、特色无菌原料药(创新药)CDMO、头孢冻干制剂CDMO、非青非头无菌粉针制剂分装CDMO、进口药品注册申报以及杂质对照品定制研究一站式服务。公司由药物研发专业团队及海内外留学人员共同组建，在药物开发、产业化研究方面有丰富的经验，特别是在抗感染研究方面具有明显的优势。现有员工200+人。近三年来公司研发人员比率稳定保持在90%以上,且研发投入逐年递增.公司拥有发明专利22项，其中PCT3项，欧洲3项,日本2项,美国3项。2020年通过国家高新技术企业认定.入选2025年工信部首批重点培育中试平台（平台名称：严重细菌性疾病抗菌药物研发中试平台），2022年广东省专精特新中小企业，2022年广州技术市场50强以及生物医药10强企业，已取得药品生产许可证B、D证。业务范围01药学研究服务（创新药和仿制药）02国内外创新药和仿制药药品注册（中美欧等申报）03无菌原料药（创新药）CDMO（0.5-20kg）无菌抗菌药物制剂生产04严重细菌性疾病抗菌药物研发中试平台05进口药品注册和药品国内外市场拓展服务实验室环境实验室环境✦₊配备核磁共振波谱仪（JNM-ECZ400S）、高分辨质谱(Thermo QE Orbitrap)、三重四极杆质谱（Thermo TSQ Quantis）、ICP-MS、GC-MS(TSQ 9000)、单四极杆质谱（Thermo/ISQ EC;Thermo/MSQ PLUS.2台）、电感耦合等离子质谱仪（ICAP-QR）、实验室真空干燥机、一百多台HPLC（Thermo/Agilent）、十多台台制备液相、十多台冷冻干燥机、傅里叶红外光谱仪、气相色谱仪、激光粒度仪、溶出仪 (SOTAX ATS Xtend) 高效包衣机、压片机、百万分之一天平等若干仪器设备。特色优势提供药学研究技术服务（创新药和仿制药），进口药品注册申报以及杂质对照品定制研究一站式服务。公司拥有国内外优秀的合成分析注册申报研发团队，产业化研究经验丰富。熟悉欧美法规市场注册要求和CGMP质量管理规范要求。现已帮助多家药企完成多个产品美国和欧洲申报，多次通过FDA现场审计无菌原料药CDMO✦₊无菌原料药车间配备搪玻璃溶解罐（300L）、无菌结晶罐（300L，不锈钢316L）、三合一机（材质316L）、双锥回转真空干燥器（200L,材质316L）、无菌分装系统（ORBAS，材质316L，柜内洁净级别A级）、封闭型高低温循环器（TCU）、CIP在线清洗站（300L,材质316L）、多效蒸馏水机（主体材质316）、纯化水制备系统（材质316）、制氮机（材质304）等若干设备。CDMO特色1小批量无菌原料药1、批量小，最小可至0.5kg，多的可至20kg；2、适合创新药和高端仿制药临床小批量无菌粉原料样品的制备；3、可制备无菌微粉化原料药，粒径可到2μm-10μm；4、在线CIP/SIP，生产过程全部密闭生产，自动化程度高；5、体系规范，符合cGMP的要求，能中美欧申报；2小批量无菌原料药3非青非头无菌粉针制剂分装CDMO（含无菌混合设备）部分代表品种近期国外注册代表性项目：Amoxicillin trihydrate Compacted CEP 2021-461-P01, Clavulanate potassium, US DMF 27903 (FDA)等20多个项目。近期进口原料：头孢噻肟钠原料药（审批结果A），头孢西丁原料药（审批结果A），头孢唑肟钠原料药（审批结果A）头孢唑啉钠原料药（审批结果A）等多个原料药。近期国内申报：创新药IMBZ18g、IMBZ19g、LT001、LT002；仿制药注射用头孢噻肟钠、注射用氟氧头孢、注射用厄他培南、注射用哌拉西林/他唑巴坦、注射用多粘菌素、头孢卡品酯颗粒、头孢妥仑匹酯颗粒、注射用磷霉素钠等60多抗生素品种，盐酸二甲双胍缓释片、孟鲁司特钠咀嚼片、来特莫韦注射液、注射用胞磷胆碱、注射用多巴胺等多个品种。大会详情 /CMC-CHINA点击下方图片了解更多▼

FDA has reevaluated data supporting amoxicillin/clavulanate breakpoints against Haemophilus influenzae . The review included a publication describing the Clinical and Laboratory Standards Institute (CLSI) rationale for revision of the amoxicillin/clavulanate breakpoints for H. influenzae . 1 Amoxicillin/clavulanate is approved in several oral formulations. Approved indications where H. influenzae infections are relevant include lower respiratory tract infections, acute bacterial otitis media, and sinusitis. CLSI revised the amoxicillin/clavulanate breakpoints for H. influenzae in 2022. The table below presents the current CLSI and FDA breakpoints. Current CLSI and FDA Amoxicillin and Clavulanate Breakpoints for H. influenzae Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm S I R S I R CLSI a ≤ 2/1 4/2 ≥ 8/4 - - - FDA b ≤ 4/2 - ≥ 8/4 ≥ 20 - ≤ 19 a. First published in the 32 nd edition of CLSI supplement M100; 2022. Breakpoints are based on a dosing regimen of amoxicillin/clavulanate of 875/125 mg PO every 12 hours or 500/125 mg PO every 8 hours. Additional disk correlate data are pending before disk diffusion breakpoints with these dosing regimens can be established. b. FDA breakpoints correspond to the CLSI breakpoints prior to the 2022 revision. Minimum inhibitory concentration (MIC) distribution data included the MIC mode, range, and estimated epidemiological cutoff value (ECV) of 0.5/0.25 mcg/mL, 0.06/0.03–16/8 mcg/mL, and 2/1 mcg/mL, respectively. Clinical data for H. influenzae infections were limited, and included studies in community-acquired pneumonia and sinusitis with no resistant isolates and no outcomes reported by ampicillin/clavulanate MIC. The FDA review team was not able to identify a specific pharmacokinetic-pharmacodynamic (PK-PD) target for amoxicillin/clavulanate against H. influenzae . This was consistent with the findings from the publication by Narayanan et al. 2 The PK data suggest MIC ≥ 4/2 mcg/mL are not reliably achievable with amoxicillin/clavulanate dosing regimens of 875/125 mg PO every 12 hours or 500/125 mg PO every 8 hours, supporting lowering the susceptible breakpoint. Overall, CLSI concluded that lowering the MIC susceptible breakpoint from ≤ 4/2 mcg/mL to ≤ 2/1 mcg/mL was compatible with the totality of data including the wild-type MIC distribution/ECV, PK/PD target attainment, and available clinical data. Adding an intermediate MIC category of 4/2 mcg/mL provides a buffer zone for expected technical variability of antimicrobial susceptibility testing. In conclusion, FDA agrees with the CLSI rationale and recognizes the amoxicillin/clavulanate MIC susceptible, intermediate, and resistant breakpoints against H. influenzae of ≤ 2/1 mcg/mL, 4/2 mcg/mL, and ≥ 8/4 mcg/mL, respectively. Additional disk correlate data are needed to establish disk diffusion breakpoints. Content current as of: 05/15/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.