东营天东制药有限公司
简介
东营天东制药有限公司成立于1992年，注册资本4.07亿元，是国家高新技术企业，也是三药集团成员公司，品牌为“双鹤 DOUBLE-CRANE”。公司主要产品包括肝素钠、依诺肝素钠、那屈肝素钙及依诺肝素钠注射液等，是国内领先的低分子肝素原料供应商，产品销往40多个国家和地区。公司已通过中国GMP、欧盟CEP、美国FDA以及巴西、瑞士、欧亚联盟GMP等多项认证，其中复杂无菌注射剂通过欧洲EMA官方GMP认证，实验室通过FDA、EU GMP认证，配备核磁共振波谱仪、高效液相色谱仪、离子色谱仪、气相色谱仪等检测仪器。2018年起，公司拓展CMO业务，主要承接非终灭预灌封/鲁尔锁生产线（1ml细长，可扩展至3ml、5ml，年产5000万支）、复杂无菌制剂生产线（西林瓶10ml、50ml，出口欧洲）、原料生产线（中间体、原料药）等，并规划卡式瓶生产线及新的复杂无菌注射剂生产线；仓储条件涵盖2-8℃、25℃以下及常温仓储区。
英文简介
Dongying Tiandong Pharmaceutical Co., Ltd. was established in 1992 with a registered capital of RMB 407 million. It is a national high-tech enterprise whose main products include Heparin Sodium, Enoxaparin Sodium, Nadroparin Calcium and Enoxaparin Sodium Injection. The company is a leading supplier of low molecular weight heparin APIs in China, with products exported to more than 40 countries and regions. It has been granted certificates from domestic and international drug authorities, including Chinese GMP, EU CEP, US FDA, Brazil GMP and Switzerland GMP. Tiandong began expanding its CMO business in 2018, undertaking non-terminally sterilized prefilled syringe/Luer lock products and complex injectables. Its complex sterile injectables have passed EU GMP inspection, and its prefilled syringe line has passed NMPA and EAEU GMP inspection. Tiandong is planning a cartridge line and a new complex sterile injection line. CMO services include: non-terminally sterilized prefilled syringe/Luer lock line (1 ml slender syringe, expandable to 3 ml or 5 ml, 50 million units per year); complex sterile lyophilized powder line (vials 10 ml, 50 ml, exported to Europe); APIs production line (stirring tanks, filters, ultrafiltration machines; clean area lyophilization, grinding, blending); cartridge filling line (under planning). The laboratory is certified by FDA and EU GMP and equipped with NMR, HPLC, ion chromatographs and GC from Agilent, Bruker and Thermo Fisher. Storage: 2-8°C, below 25°C and room temperature areas.
联系方式
- 其他：资质认证：中国GMP、欧盟CEP、美国FDA、巴西GMP、瑞士GMP、EMA GMP、EDQM、EAEU GMP；实验室通过FDA、EU GMP认证；商标TIANDONGPHARMA；三药集团成员公司；关联品牌双鹤 DOUBLE-CRANE。备注：OCR变体，英文名逗号后空格已按标准格式校正。
供应信息
依诺肝素钠679809-58-6、类肝素391208-81-4、肝素钙37270-89-6、肝素钠9041-08-1