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Question:Have your company received the GMP certificate?

In May 2004, we received the GMP certificates for the 15 APIs manufactured in the new plant. In 2005, we received the GMP certificates for the 4 new products.

Question: Could you tell me when your company was founded? And what are your main products?
Our company was founded in 2002, which was built and held by both Linuo Group and Shandong Pharmaceutical Industry Research Institute. We mainly manufacture new medicines raw materials such as Glicalzide ,Metformin Hydrochloride ,Isosorbide Mononitrate ,Xantinol Nicotinate, which treat diabetes or coronary heart disease .

Question: Did your company get the COS or DMF or FDA certificate?

According to the market requirement , our company is striving to prepare all relative documents of Glicalzide for the FDA certificate and DMF in India and Korea.In May 2005, we obtained DMF (RN: 20050831-1-C-5-03) in South Korea for the key product gliclaizde. At present ,the US DMF application dossiers for 5-ISMN and Isoflurane will be completed soon. In the earlier of Oct. 2007, we obtained the EDQM COS Certificate for Gliclazide.

   

 


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