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Dongying Tiandong Biochemical industry Co.,LTd, established in 1992, is a special manufacturer of glycosaminoglycans, such as Heparin Sodium, Heparan Sulfate, Dermatan Sulfate, low molecular weight heparins, Hyaluronic Acid.
As for the product of heparin, we have its GMP certificate and DMF as well. Virus certificate is available. There are two contracted bases that supply us crude heparin sodium, which enables the traceability up to slaughterhouse.
Regarding the product of Enoxaparin sodium, we have gotten FDA DMF registration No. 18452 in 2005 and also received the DMF Acknowledgement Receipt from EDQM CEP 2005-258.The manufacturing plant is GMP certificated. A new workshop specialized in Enoxaparin Sodium has put into production. It is designed according to GMP requirement. Iranian Ministry of Health has audited our enoxaparin facilities and Iranian GMP has been granted in May,2007.Iranian Ministry of Health has audited our enoxaparin facilities and Iranian GMP has been granted in May, 2007. We also have passed the site inspection of EDQM in June, 2007. We also have gotten FDA DMF registration No. 20905 for dalteparin in Oct, 2007. The attestation of Inspection has been granted by EDQM on March 12th,2008. COS certificate No.RO-CEP 2005-258-Rev 00 was granted on Nov.13,2008.
Drug Master Files are available both for Dalteparin sodium and Nadroparin Calcium. There are other low molecular weight heparins which are under development, including Certoparin, Parnaparin, Bemiparin, Tinzaparin, Ardeparin etc.
There are advanced analytical facilities and highly-trained lab stuff in quality control center. Furthermore, stringent GMP monitoring and quality assurance systems are established to ensure every process complying with GMP requirements. All the products comply with the current BP, USP and EP.
We sincerely hope to develop a mutual long-term cooperation with your esteemed company! |
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| heparin , enoxaparin, heparin sodium, heparin calcium, low molecular weight heparin, hyaluronic acid, nadroparin , dalteparin |
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| Company : |
Dongying Tiandong Biochemical Industry Co.,Ltd |
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Contact us |
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China |
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