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ZHEJIANG HISUN PHARMACEUTICAL CO.,LTD.
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Tacrolimus has sufficient capacity for stable supply, has obtained CEP certificate, has passed EU and CDE review, and has been submitted to US. As a comprehensive pharmaceutical enterprise with complete research, production and marketing value chain and multi-region development, Hisun Pharmaceutical owns three major production bases of APIs, with perfect production lines covering nearly 100 varieties, and is one of the important producers of speciality APIs in the world.
Hisun Pharmaceutical is equipped with advanced production equipment and facilities and testing instruments, and its production, testing and release follow the requirements of GMP; Hisun Pharmaceutical has a central research institute at its headquarters in Taizhou, a nationally-recognised enterprise technology centre, a provincial academician's workstation, and the first postdoctoral scientific research station in the province with independent enrolment qualification; the R&D platform is equipped with a R&D laboratory and a small and medium-sized pilot plant, which provides seamless linkage between the development and industrialisation of new products and new processes. The R&D platform is equipped with R&D laboratories and small and medium-sized pilot production workshops, providing a seamless connection from new product and process development to industrialisation.
Hisun Pharmaceutical is equipped with a professional quality management team and a perfect quality management system, covering the whole life cycle of drug quality;
The pharmaceutical administration system of Hisun Pharmaceutical can efficiently support the global registration affairs of customers and provide better products and services for global customers;
Hisun Pharmaceutical establishes an EHS laboratory, equipped with a professional research team and advanced experimental equipment, a perfect EHS integrated management system and a professional EHS management team to escort the company's safe production and green development. The laboratory management system passed CNAS certification in 2018.
Hisun Pharmaceutical adheres to the development concept of "no best, only better", and looks forward to working with you hand in hand! |
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ZHEJIANG HISUN PHARMACEUTICAL CO.,LTD.
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For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was given FDA approval in 1994 for use in liver transplantation. Since then, this indication has expanded to kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis；
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients., , Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
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Beijing Global Biologicals Co.Ltd
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immunosuppressive product tacrolimus
Specification:
Tacrolimus is chemically known as a macrolide. In T-cells, activation of the T-cell receptor normally increases intracellular calcium, which acts via calmodulin to activate calcineurin. Calcineurin then dephosphorylates the transcription factor NF-AT (nuclear factor of activated T-cells), which moves to the nucleus of the T-cell and increases the activity of genes coding for IL-2 and related cytokines. Tacrolimus prevents the dephosphorylation of NF-AT. In detail, Tacrolimus reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex interacts with and inhibits calcineurin thus inhibiting both T-lymphocyte signal transduction and IL-2 transcription. Although this activity is similar to ciclosporin, studies have shown that the incidence of acute rejection is reduced by tacrolimus use over ciclosporin. Although short-term immunosuppression concerning patient and graft survival is found to be similar between the two drugs, tacrolimus results in a more favorable lipid profile, and this may have important long-term implications given the prognostic influence of rejection on graft survival.
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Pharma Sources Insight June 2024: Globalization on the Go
