文字内容
1. Jiangxi Alpha Hi-Tech Pharmaceutical Co., Ltd. Jiangxi , China 江西阿尔法高科药业有限公司 Jiangxi Alpha Hi-Tech Pharmaceutical Co., Ltd.
2. CONTENTS 01 公司概况 02 研发团队 03 硬件设施设备 04 Profile R&D Team Facility&Equipment 质量保证体系 Quality Assurance System 05 主营产品与技术优势 06 未来展望 Key Products Future Visions
3. 01 公司概况 Profile
4. 公司概况 Profile 江西阿尔法高科药业有限公司由制剂高级工程师缪志毅 等 2009 年 2 月投资成立,是一家以对接引进国际高端药 用辅料的药品生产、研发和销售企业, 2016 年被评为国 家高新技术企业。依托公司设立的江西省药用辅料工程技 术研发中心,具备独立开发化学医药原辅料、制剂等产品 的科研设施和科研团队;公司拥有药用辅料生产车间约 10000 ㎡,食品添加剂生产车间约 1000 ㎡,拥有通过 国家药品监督管理局 GMP 认证的滴眼液无菌生产车间约 1000 ㎡ ,公司全面实行 GMP 规范管理。 阿尔法高科 药业荟萃了一批充满朝气且专业素养深厚的高层次科研、 技术服务营销团队,拥有一批现代医药企业的管理和技术 专家,公司始终坚持客户利益第一的原则,为国内外客户 提供卓越医药技术和产品服务。 Our corporation has a pharmaceutical excipient 80% workshop of 10000m2, a food additive workshop of 1000m2 and an aseptic eye drop workshop of 1000m2 certified by GMP, which are all under GMP regulation.
5. 公司概况 —— 行业地位 Industry Position 江西阿尔法高科药业有限公司 —— 药用辅料生产行业中处于省内第一国内先进行业地位 Provincial No. 1 & Domestic advanced industrial position for pharmaceutical excipients 01 02 03 省级民营科技企业 江西省药用辅料工程技术研究中心 国家高新技术企业 Provincial private science and technology enterprise Jiangxi Provincial Pharmaceutical Excipient Engineering Technology R&D Center National high-tech enterprise
6. 公司概况 —— 研发成果 R&D Achievements 二甲硅油、三乙醇胺、山嵛酸甘油酯、油酸乙酯、三氯叔 丁醇、聚乙烯醇、麝香草酚等 37 个药用辅料品种生产批 准文号。 三氯蔗糖、聚乙烯醇、山嵛酸甘油酯、油酸乙酯四个产品 的食品添加剂生产许可。 We achieved 37 varieties CDMF register No. for pharmaceutical Sucralose, Behenate PVA, is Ethyl listed production license. excipients, in where Oleate,Glyceryl food additive
7. 公司概况 —— 研发成果 R&D Achievements 目前公司有 12 个为国内首家研发成功的药用标准产品,获得了 6 项国家发明专利。参与了 2020 版中国药典药 用辅料聚乙烯醇、二甲硅油、油酸乙酯等 8 个品种的标标 准提高工作。开展了 标 标 标 标 标 标 标 标 30 多个药用辅料品种的关联研究,其中 15 个已在国家药品监督管理局备案;另有 5 个品种(如氢化蓖麻油、氢化大豆油、聚乙烯醇等)正在激活并已在近 20 个药品中通过一致性评价并达到与仿制药等效,成为国内首家通过一致性评价的药用辅料品种;质量符合中国药 典和美国药典等国际标准要求。 We are the first company to successfully developed 12 pharmaceutical grade excipients, achieved six national invention patent. Participated in the standard improvement for 2020 edition of the ChP pharmaceutical excipients such as polyvinyl alcohol, dimethicone, ethyl oleate,etc, totally 8 products. More than 30 pharmaceutical excipients have been association studied, 15 of which have been registered in CFDA. Another 5 varieties (such as hydrogenated castor oil, hydrogenated soybean oil, polyvinyl alcohol, etc.) are being activated and have passed the consistency evaluation in nearly 20 drugs and reached the equivalence with generic drugs, becoming the first pharmaceutical excipient in China to pass the consistency evaluation.
8. 6 项发明专利 Six Invention Patents 滴眼液制剂 /GMP 无菌车间 Aseptic workshop for eye drop preparation
9. 6 项发明专利 Six Invention Patents
10. 研发团队 R&D Team 02
11. 研发团队 R&D Team 公司现已组建江西省药用辅料工程技术研究中 心,中心有研发团队 18 人,约占企业总人数 的 23% ,其中博士 3 人,硕士 6 人,本科 9 人。 Our company has established Jiangxi Provincial Pharmaceutical Excipients Engineering Technology R&D Center, owning a R & D team of 18 employees, including 3 doctors, 6 masters, and 9 graduates.
12. 精密检验设备 --- 一体化 R&D Center&Precise Instruments---Integration
13. 精密检验设备 ——自动化 R&D Center&Precise Instruments ——Automation 高效液相色谱仪 HPLC
14. 精密设备 ——多样化 R&D Center&Precise Instruments ——Diversification 水分测定仪 Moisture Meter 分析天平 Analytical Balance 气相色谱仪 GC(Gas Chromatograph)
15. 03 硬件设施设备 Facility&Equipment
16. 硬件设施设备 Facility&Equipment • 公司拥有先进的设备设施,具有多功能的不同反应步骤: • 不锈钢反应釜有 20 多套,分别有: 500L 、 1000L 、 2000L 、 3000L 、 5000L 、 8000L 等多种型号; • 搪瓷反应釜 10 多套,也有: 500L 、 1000L 、 2000L 、 3000L 、 5000L 、 8000L 等多种型号; • 匹配双锥回转真空干燥设备: 500L 、 2000L 、 4000L ; • 另还有喷雾干燥设备、低温粉碎设备、万能粉碎设备等先进的辅助设备设施
17. 生产设备 —先进性 Production Facilities---State-of-the-art 低温粉碎设备 Cryogenic comminution equipment 喷雾造粒设备 Spray granulating equipment
18. 生产设备 —全面性 Production Facilities---Comprehensiveness 中试设备 Pilot equipment 蒸馏设备 Distillation equipment
19. 生产设备 ——多功能化 Production Facilities ——Multifunctionalization
20. 生产设备 —自动化 Production Facilities--Automation
21. 生产设备 —精细化 Production Facilities-Refinement
22. 独立的环保系统 Independent environmental protection system
23. 安全的库房 Safe warehouse
24. 04 Quality Assurance System 质量保证体系
25. 质量保证体系 Quality Assurance System • 药用辅料生产车间约 10000 ㎡,食品添加剂生产车间约 1000 ㎡, 拥有通过国家药品监督管理局 GMP 认证的滴眼液无菌生产车间约 1000 ㎡ ,公司全面实行 GMP 规范管理。 • 公司通过了多种食品行业认证,如 ISO9001, ISO14001, OHSAS18001,BRC, FSSC22000, OU KOSHER, IFANCA HALAL.etc. • 我们的产品符合 ChP2015, USP40-NF35, BP2017, EP9.0 等药典 • Our corporation has a pharmaceutical excipient workshop of 标准。 10000m2, a food additive workshop of 1000m2 and an aseptic eye drop workshop of 1000m2 certified by GMP, which are all under GMP regulation. • Multiple food certifications have been obtained such as above list. • Our product quality strictly conforms to the ChP2015;USP40NF35;BP2017;EP9.0,etc
26. 公司组织结构图 Organization Chart 质量授权人
27. 质量管理部组织机构图 Organization Chart of Quality Dept. 质量管理部经理 Quality Manage Dept. Manager QA 经理 QC 经理 QA Manager QC Manager 理化检验员 Physical & Chemical Inspector 仪器 检验员 Instrument inspector 微生物检验员 Microorganism Inspector 文件 QA Document QA 现场 QA Site QA 物料 QA Material QA 验证 QA Validatio n QA 审计 QA Audit QA
28. 质量、产品安全目标 Product quality and safety objectives  产品一次检验合格率≥ 98% ; Product primary inspection pass rate ≥98%;  原料验收合格率≥ 99% ; Raw material acceptance rate ≥99%;  顾客满意度≥ 85% ; Customer satisfaction ≥85%; 重大食品安全投诉 0 ; Major food safety complaints 0;  法检合格率 100 %。 The Method acceptance rate is 100%.
29. 环境方针 Environmental Policy  贯彻执行环保法规,科学管理,严格执法,防治污染;  教育职工增强环境意识,掌握环保知识,遵守环保法规;  研究开发绿色产品,积极推行清洁生产,持续改进,保护人类共同家园。  To implement environmental laws and regulations, conduct scientific management, enforce laws strictly, and prevent and control pollution;  Educate employees to enhance environmental awareness, master environmental knowledge, and abide by environmental laws and regulations;  Research and development of green products, actively promote clean production, continuous improvement, to protect the common homeland of mankind.
30. 环境目标 Environmental Objectives  污水处理池沉淀泥的处置符合国家法规的要求,严格按照国家关于危险固废处置 的规定处置,处置率 100%  工厂厂界噪声符合国家法规要求,噪声小于 60dB  生产废水达标排放,生产废水经处理后相关指标符合国家规定( PH : 6~9 , COD≤100mg/L, 氨氮≤ 15mg/L )  The disposal of settling mud in sewage treatment ponds shall comply with the requirements of national laws and regulations, and shall be handled in strict accordance with the national regulations on the disposal of dangerous solid wastes, with a disposal rate of 100%  The noise at the factory boundary meets the requirements of national laws and regulations, and the noise is less than 60dB  Discharge of production wastewater is up to standard, and relevant indicators of production wastewater after treatment are in accordance with national regulations (PH: 6-9, COD≤100mg/L, ammonia nitrogen ≤15mg/L).
31. 职业健康安全方针 Occupational health and safety policy “ 安全第一、预防为主”,科学管理,严格执法,遏制事故,确保安全; 宣传职业安全卫生知识,提高职工的安全文化素质,自觉遵守安全法律法规 ;  产品设计必须符合安全规范。  "Safety first, prevention first", scientific management, strict law enforcement, containment of accidents, to ensure safety;  Publicize occupational safety and health knowledge, improve safety cultural quality of employees, consciously abide by safety laws and regulations;  Product design must comply with safety specifications.
32. 职业健康安全目标 Occupational health and safety objectives  产品质量安全复合国家标准,无重大质量安全事故; Product quality safety is compounded with national standards, there is no major quality safety accident;  公司员工职业病发生率为 0 ; The incidence of occupational disease among employees is 0;  公司重大火灾、伤亡事故为 0 。 The company's major fire, casualty accident is 0.
33. 公司资质 Business License & Food Manufacturing License
34. 公司资质 Business License & Food Manufacturing License 《 GMP 》 (2010 年版 ) 《药品生产质量管理规 范》 GMP Certificate & Drug Manufacturing License
35. 质量保证体系 Quality Assurance System HALAL 证书 OU Kosher 证书
36. 质量保证体系 Quality Assurance System SGS ISO9001:2015'>ISO9001:2015 质量管理体系 SGS ISO9001:2015'>ISO9001:2015 Quality Management System SGS ISO14001:2015 环境管理体系 Environment Management System
37. 质量保证体系 Quality Assurance System SGS ISO18001 : 2007 职业健康管理体系 SGS ISO22000 : 2005 食品安全管理体系 SGS ISO18001 : 2007 Occupational health management system Food Safety Management System
38. 质量保证体系 Quality Assurance System SGS BRC 英国零售食品安全全球标准 SGS BRC UK global standard for retail food safety SGS FSSC 22000 食品安全管理体系 Food Safety Management System
39. 05Key Products & 主营产品与技术优势 Technical Advantages
40. 国内主营产品: Domestic Key Products 主打产品为药用辅料,其中有 12 个品种为国内首家研发成功的药用标准产 品,填补国内空白,分别为二甲硅油、三乙醇胺、油酸乙酯、山嵛酸甘油酯、氢化 蓖麻油、标 化大豆油、聚乙 标标标标标标标标标 醇、麝香草酚、三 标标标标标标标标标 蔗糖、苯扎 标标标标标标标 、腺 标标标 呤。 标 Our key products are pharmaceutical excipients. we're the first company successfully developing 12 excipients ,filling the domestic gap. They are, Dimethicone; triethanolamine; Ethyl Oleate; Glyceryl Behenate; Hydrogenated Castor Oil; Hydrogenated Soybean Oil; Polyvinyl Alcohol; Thymol; Sucralose; Benzalkonium Chloride; Adenine.
41. 出口主营产品: Exporting Key Products 油酸乙酯、山嵛酸甘油酯、硬脂富马酸钠、聚乙烯醇、氢化蓖麻油、氢化大 豆油 苯扎氯铵、丁羟甲苯、三氯叔丁醇 Ethyl Oleate; Glyceryl Behenate; Sodium Stearyl Fumarate; Polyvinyl Alcohol ( PVA ) ; Hydrogenated Castor Oil; Hydrogenated Soybean Oil; Benzalkonium Chloride; Butylated Hydroxytoluene(BHT); Chlorobutanol
42. 主要特色产品: 药用油酸乙酯 Pharmaceutical Grade Ethyl Oleate 药用油酸乙酯在药剂中主要用作溶剂、增塑剂、润滑 剂和透皮促进剂,是甾类化合物和油溶性药物的良好溶剂 ,具有黏性小又易被迅速吸收的特性,故常用于制造注射 剂、搽剂、软膏剂等,是药品注射剂里最贵重的溶媒之一 。 该产品各项质量指标等同甚至超过英国禾大化学同品 种。 具有技术优势和价格竞争力。 Ethyl oleate is mainly used as a solvent, plasticizer, lubricant and transdermal promoter in pharmaceutical products. It is a good solvent for steroids and oil-soluble drugs. It has small viscosity and easy to be absorbed quickly. Its quality index is the same as or even better than that of British HEDA chemical,With technical advantages and price competitiveness.
43. 主要特色产品: 山嵛酸甘油酯 Glyceryl Behenate 用作非离子表面活性剂,具有乳化、分散、消泡和润滑作用 ;可作为乳化剂和乳化稳定剂,主要用于民生与军工医药行业 ,包括生物医药和化工医药行业领域,制备医药乳剂、乳膏剂 、油膏剂。山嵛酸甘油酯在药剂中的主要用途是在片剂、丸剂 、颗粒剂和胶囊剂制造中用作润滑剂;作分散剂,在固体、半 固体和液体制剂中也有广泛的用途;还可用于缓释片,并作为 水溶性药物缓释制剂的骨架。在生物技术运用方面具有广阔运 用前景。 This product can be used as a binder and lubricant for tablets and capsules, as a backbone material or coating material for sustainedrelease preparations, as a thickener for silicone gelling agents and emulsions, as a taste masking agent. It has broad application prospects in the application of biotechnology.
44. 主要特色产品: 聚乙烯醇 Polyvinyl Alcohol 药用聚乙烯醇( PVA )由聚醋酸乙烯酯的甲醇溶液经过碱的醇 解反标 而得到。 标标标标 公司是国内目前唯一批量生产上市的药用 PVA 生产企业,是国 内目前唯一既可以符合中国药典标准、同时又可以符合欧洲药典 ( EP )和美国药典( USP) 标准的产品。 This product is prepared by alcoholysis of polyvinyl acetate in methanol solution by adding alkali solution. At present, we're the only pharmaceutical PVA manufacturer that is massproduced and listed in China. It is the only product that can meet ChP, EP and USP standards.
45. 06未来展望 Future Visions
46. 未来展望 Future Visions 公司以江西为中心,建立了辐射全 国的营销和服务网络,药用辅料聚乙烯 醇、油酸乙酯等 37 品种,年产量达 1800 吨,远销荷兰、巴西、俄罗斯等 国,畅销国内 25 个省市。 With jiangxi as the center, we established a nationwide marketing &service network, with an annual output of 1800 tons of 37 varieties, such as polyvinyl alcohol and ethyl oleate, which are exported to the Netherlands, Brazil, Russia and 25 provinces&cities in China. 公司销售辐射图
47. 合作伙伴 Partners
48. 未来展望 Future Visions 公司战略: 力争成为国内医药行业最卓越的企业之一,在生物医药新材料的科研、生产及生物 医药技术专利方面成为国内行业领头羊及行业典范,同时在专科药用领域获得国内举足 标 重 的位置。 Corporate Strategy : Strive to become one of the most outstanding enterprises in the domestic pharmaceutical industry, become the domestic industry leader and industry model in the research, production and bio-pharmaceutical technology patent of new materials, and gain a pivotal position in the field of specialty medicine in China.
49. 未来展望 Future Visions 基本目标: 技标标 水平、 标 标 标标 模国内 标 标 标标 先 Basic Goal : Leading technology level and scale in China 阶段性目标: 研发能力行业典范,引领药用辅料行业发展 Phased Goal : R&D ability industry model, leading the development of pharmaceutical excipients industry 最标 目 标 标标 : 综合能力全球先进 Final Goal : Comprehensive capabilities globally advanced 全系列: 在现有产品基础上,不断拓展 Full Series : On the basis of existing products, continue to expand
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