济南金达药化有限公司(简称JDPC)有四十二年专业化学合成医药原料药的生产历史。
21个原料药(API)品种通过中国GMP认证。
四次通过美国FDA现场检查:卡洛芬-2010年7月,呋喃西林-2007年9月,丹曲林钠-2004年11月,呋喃唑酮-1998年8月。呋喃妥因系列产品正在申请CEP证书,禁发 禁发 ***托哌酮、曲司氯铵等多个品种已经提交DMF/EDMF文件。
我们的发展定位就是“做美欧规范市场一流的API供应商”。多年来我们积极践行cGMP,不断完善提高EHS系统支持;我们每年接受十几次客户审计与第三方审计,可以证明JDPC的质量保证系统是稳定可控的。
我们有Sanofi-Aventis, Boehringer Ing, Mepha GmbH, Zach, Neogen, Lonza AG, Cipla, Actavis ,Sun等很棒的客户的信赖和支持。
期望我们的“规范生产平台”能够为您的产品进入美、欧规范市场提供可靠、持久的支持。
Jinan Jinda is an enterprise mainly engaged in the manufacturing and sales of APIs with a history of more 42 years. 21 APIs have passed China GMP inspection.
4 products were approved by US FDA, that is, Carprofen in July of 2010, Nitrofurazone in September of 2007, Dantrolene sodium in November of 2004, and Furazolidone in August of 1998. CEP for Nitrofurantoin is under going, and DMF/EDMF for Tolperisone HCl and Trospium chloride has been submitted.
Our goal is to be a best API supplier for generic drug maufacturers in US and EU. We have been carrying out cGMP and improving the EHS system for years. Our facilities are audited by the customers and the third parties for more than ten times every year which could demonstrate that the quality system of JDPC is under control.
We have a lot of very good customers to trust and support us, such as Sanofi-Aventis, Boehringer Ing, Mepha GmbH, Zach, Neogen, Lonza AG, Cipla, Actavis and Sun.
We hope our "regulatory manufacturing platform"could give you reliable and abiding support for your products to launch into US and EU regulatory markets.
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