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南京海陵药业CMO/CDMO业务简介

  • 2026-04-19 15:09:09
南京海陵药业CMO/CDMO业务简介

HAILING

南京海陵药业

CMO/CDMO业务简介

以高质量服务实现合作共赢

企业简介

扬子江药业集团南京海陵药业有限公司是由扬子江药业集团于2001年1月投资兴建的全资子公司，厂区占地总面积约330亩，厂房按照GMP要求设计，引进国际先进水平的设备，厂区环境优美，地面绿化、道路等按医药行业标准建设。公司牢记“求索进取、护佑众生“的企业使命，不断开拓创新，目前已成为一家集科研、生产、营销为一体的国家高新技术企业。

公司先后获批国家工程研究中心、江苏省院士工作站、栖霞区区长质量奖、南京市市长质量奖、江苏省省长质量奖（提名奖）、江苏省绿色工厂、江苏省互联网标杆工厂、国家绿色工厂等。

CMO/CDMO服务

01 服务内容

▶ CRDMO全链条服务

▶ OEM（贴牌）生产

▶ 药品研发中试放大生产

▶ 药品临床药品制备

▶ 注册申报批（工艺验证）生产

▶ 商业化委托生产

▶ 稳定性考察

02 产线介绍

终端灭菌小容量注射剂

洁净区面积：412.1m2

设备产能：500L+1000L+1000L

年生产能力：5000万支

包装形式：1ml、2ml、5ml、10ml安瓿

主要生产设备：配液系统（奥星+GEA）、热风层流灭菌隧道（德国B+S）、安瓿灌封机（德国B+S）、饱和蒸汽灭菌柜（意大利FEDEGARL）、全自动灯检机（意大利贝威蒂）、安瓿瓶检漏机（日本IDK）

大容量注射剂

洁净区面积：621.4m2

设备产能：1500L+3000L

年生产能力：1300万瓶

包装形式：50ml、100ml、250ml玻璃输液瓶

主要生产设备：不锈钢配液系统（德国GEA）、输液洗瓶机（德国B+S）、胶塞处理机（意大利ICOS）、灌装脱氧加塞机（德国B+S）、过热水喷淋旋转式灭菌柜（奥地利SBM）

口服固体制剂

总建筑面积：5563 m2

D级净化面积：1096.04m2

一般区面积：444.96m2

年生产能力：片剂—12亿片、胶囊剂—10亿粒

包装形式：硬双铝、铝塑、塑瓶

主要生产设备：湿法混合制粒机（德国GLATT、创志）、湿式整粒机（德国GLATT）、流化床喷雾干燥制粒机（德国GLATT、创志）、干式整粒机（德国GLATT、创志）、全自动旋转式高速压片机（德国KILLIAN、菲特）、泡罩机（意大利IMA）、胶囊充填机（MG2、BOSCH公司）

03 CMO优势

运营平稳，产能稳定，供应链保障充分

公司拥有经验丰富的生产、质量、技术、研发管理团队，从早期研发、工艺开发到商业化生产的完整流程，为客户提供一站式CRDMO解决方案，以高质量服务实现合作共赢。生产设备以进口为主，确保产能稳定，体系运营平稳，保证市场供货。

立体综合库2018年10月启用，占地面积为7040㎡，货位数4756个，采用目前行业内主流的立体高架库及WMS系统，自动化程度高、质量控制全面。

管理体系融合，持续完善

公司质量管理体系健全，已通过GMP认证、测量管理体系认证、CNAS认证、质量环境和职业健康安全整合型管理体系认证，同时公司采用以“三不原则”和“四持续方法”为核心内容的药品质量风险管控模式，对药品质量风险进行高标准的动态管理，采用多系统自动化控制，实现产品全过程追溯，确保产品质量。

质量检测中心配备各类精密检测仪器，引入Labx实验室管理软件、Agilent色谱网络版、LIMS实验室信息管理系统，实验室仪器、检验流程的信息化管控，做到数字化、可视化、可追溯。

专业的技术转移团队，提供技术支持

公司具有专业的技术转移团队，完成了30余个产品的技术转移工作，包括研发阶段的中试放大生产和工艺验证、新产品获批上市、生产场地变更、在产品种的变更等，积累了丰富的转移及注册经验，可以提供技术支持，助力项目顺利落地。

生产地址：江苏省南京市栖霞区仙林大道9号

联 系 人：

关先生 13584058866

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  1. CONNECT:[ UseTime:0.001345s ] mysql:host=127.0.0.1;port=3306;dbname=b460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001643s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000689s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000700s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001528s ]
  6. SELECT * FROM `set` [ RunTime:0.000607s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001443s ]
  8. SELECT * FROM `article` WHERE `id` = 498950 LIMIT 1 [ RunTime:0.001080s ]
  9. UPDATE `article` SET `lasttime` = 1776588093 WHERE `id` = 498950 [ RunTime:0.006903s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000618s ]
  11. SELECT * FROM `article` WHERE `id` < 498950 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.001057s ]
  12. SELECT * FROM `article` WHERE `id` > 498950 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.001105s ]
  13. SELECT * FROM `article` WHERE `id` < 498950 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.019714s ]
  14. SELECT * FROM `article` WHERE `id` < 498950 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.005542s ]
  15. SELECT * FROM `article` WHERE `id` < 498950 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002212s ]
0.209508s