21個(gè)原料藥(API)品種通過(guò)中國(guó)GMP認(rèn)證。
四次通過(guò)美國(guó)FDA現(xiàn)場(chǎng)檢查:卡洛芬-2010年7月,呋喃西林-2007年9月,丹曲林鈉-2004年11月,呋喃唑酮-1998年8月。呋喃妥因系列產(chǎn)品正在申請(qǐng)CEP證書(shū),禁發(fā) 禁發(fā) ***托哌酮、曲司氯銨等多個(gè)品種已經(jīng)提交DMF/EDMF文件。
我們的發(fā)展定位就是“做美歐規(guī)范市場(chǎng)一流的API供應(yīng)商”。多年來(lái)我們積極踐行cGMP,不斷完善提高EHS系統(tǒng)支持;我們每年接受十幾次客戶(hù)審計(jì)與第三方審計(jì),可以證明JDPC的質(zhì)量保證系統(tǒng)是穩(wěn)定可控的。
我們有Sanofi-Aventis, Boehringer Ing, Mepha GmbH, Zach, Neogen, Lonza AG, Cipla, Actavis ,Sun等很棒的客戶(hù)的信賴(lài)和支持。
期望我們的“規(guī)范生產(chǎn)平臺(tái)”能夠?yàn)槟漠a(chǎn)品進(jìn)入美、歐規(guī)范市場(chǎng)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.