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          Quality management

          The manufacturing scope in our drug manufacturing license covers drug substances and sterile drug substances. Specifically, we have passed U.S. FDA establishment inspection and Japan PMDA GMP inspection with regard to Vancomycin Hydrochloride. We hold CEPs and EU-GMP for Vancomycin Hydrochloride and Teicoplanin. Our Kanamycin Sulfate and Kanamycin Acid Sulfate have passed WHO prequalification. Besides, Written Confirmations for Active Substances Exported to EU are obtained for products of Daptomycin, Kanamycin Sulfate, Kanamycin Acid Sulfate, Colistimethate Sodium, Tobramycin Sulfate, etc. The manufacturing/inspection scope of our Veterinary Drug Manufacturing License and Veterinary Drug GMP Certificate include Premix, non-sterile drug substance (Colistin Sulfate) and non-sterile drug substance (Milbemycin Oxime) (For Export Only). We hold Approval Number issued by Ministry of Agriculture of China and Free Sale Certificate for Colistin Sulfate and Premix. Besides domestic Approval Number, CEP has been obtained for Colistin Sulfate. Our Kanamycin products and Colistin Sulfate are both ranked first in the world in terms of production capacity and output value; the global market share of products such as Vancomycin Hydrochloride, Milbemycin Oxime and Colistimethate Sodium also reaches the top three. We are one of the most complete and most competitive suppliers in the high-end antibiotic market.


          Human Use——

          Dug Manufacturing License


          Written Confirmations for Active Substances Exported to EU for Daptomycin, Kanamycin Sulfate, Kanamycin Acid Sulfate, Colistimethate Sodium and Tobramycin Sulfate.

          WHO CPQ for Kanamycin Sulfate and Kanamycin Acid Sulfate

           


          U.S. FDA and Japan PMDA GMP Compliance Certificate for Vancomycin Hydrochloride


          CEPs for Vancomycin Hydrochloride and Teicoplanin



          EU GMP Certificate for Vancomycin Hydrochloride and Teicoplanin


          DCGI (Drug Controller General of India) Registration Certificate for Tobramycin Sulfate

           

          Veterinary Use——

          Veterinary Drug Manufacturing License


          Free Sale Certificate of Veterinary Drug


          Approval Number for Colistin Sulfate and Premix



          CEP for Colistin Sulfate



          GMP Certificate for Premix, non-sterile drug substance (Colistin Sulfate), non-sterile drug substance (Milbemycin Oxime) (For Export Only)


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