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1、Nomenclature
English name： Cyclosporin

2、Structural formula

Molecular formula：C₆₂H₁₁₁N₁₁O₁₂           
Molecular mass：1202.63    
CAS No.：59865-13-3 

3、Mechanism and clinical use:

(Cyclosporine A) is a cyclic polypeptide containing 11 amino acids and is a potent immunosuppressant. It inhibits cell-mediated responses. At the cellular level, cyclosporine inhibits the production and release of lymphokines, including interleukin 2 [T-cell growth factor (TCGF)]. It blocks resting lymphocytes in the G0 or G1 phase of the cell cycle and inhibits antigen-triggered lymphokine release via activated T cells. All evidence shows that cyclosporine acts specifically and reversibly on lymphocytes without affecting haematopoietic and phagocytic functions. The use of cyclosporine to prevent rejection and graft-versus-host disease has led to successful transplantation of solid organs and bone marrow in humans. In addition, cyclosporine also has therapeutic effects on many diseases that are known or may be caused by autoimmunity.

It is used for anti-rejection of organ transplantation and selective treatment of autoimmune diseases.

On June. 2020, Cyclosporine passed GMP  certification .

On Dec .2020, API Cyclosporine was granted “written confirmation for active substance exported to EU”.

4、Executive standards
CP、EP、USP、IP

5、Qualification certificate
Register 'A' status; Domestic GMP; WC license; COPP certificate, CEP certificate, US DMF registration number, Indian registration certificate, JMF certificate, and AFM certificate.

6、Packaging size specification

Inner package: single-layers polyethylene bag and aluminum foil bag.

Outer package: aluminum bottle (pharmaceutical use).

Packaging size: 10kg/bottle

1、Nomenclature

English name：Mycophenolate Mofetil (MMF) 

2、Structural formula

Molecular formula：C₂₃H₃₁NO₇        
Molecular mass：433.50       
CAS No.： 128794-94-5

3、Mechanism and clinical use:

Mycophenolate Mofetil synthesized by macaulophenic acid and morpholine ethanol is a novel immunosuppressant against purine metabolism. It is used to prevent rejection after kidney transplantation and to treat acute rejection and refractory rejection after transplantation.

Mycophenolate mofetil has a stronger inhibitory effect on EB virus induced B lymphocyte blast transformation.

(1) When used in combination with other immunosuppressive agents, it increases the risk of lymphoma and other malignant tumors (especially skin cancer), and excessive suppression of the immune system may also increase the chance of infection.

(2) The plasma concentration of MPA did not change significantly when acyclovir or ganciclovir was combined with acyclovir. In contrast, patients with impaired renal function had increased concentrations of acyclovir or ganciclovir when combined.

(3) Sulfopyrazone may interfere with the secretion of sulfopyrazone from renal tubules, and the toxicity of sulfopyrazone may increase when combined with sulfopyrazone.

(4) With magnesium or aluminum containing antacids (such as magnesium hydroxide, aluminum hydroxide), absorption of the drug is reduced.

(5) Echinacea can stimulate the immune system, which may reduce the efficacy of the drug.

(6) Iron can reduce the absorption of the drug and decrease its efficacy.

(7) The efficacy of the drug may be reduced by concomitant use with drugs that can interfere with the enterohepatic circulation, such as cholestyamin.

(8) The possibility of changing the pharmacokinetic parameters of oral contraceptives after long-term use of this drug cannot be excluded. This may lead to reduced efficacy of oral c

4、Executive standards
CP

5、Qualification certificate
Register 'A' status; Domestic GMP; WC License

6、Packaging size specification

Inner package: double-layers polyethylene bag and aluminum foil bag.

Outer package: fiber drum.

Packaging size: 20 kg/drum

Tacrolimus

1、Nomenclature
English name：Tacrolimus

2、Structural formula

Molecular formula：C₄₄H₆₉NO₁₂S    
Molecular mass：804.02    
CAS No.：104987-11-3

   
3、Mechanism and clinical use:

Tacrolimus is strong-efficacy macrolide immunosuppressant. At the molecular level, its effect is mediated through protein FKBP12 in cytoplasm which is binding with it.FKBP12 makes Tacrolimus into cell and form a complex that competitively binds specifically to calmodulin and inhibits calmodulin (the latter mediates calcium-dependent inhibitory signal transduction system in T-cells), so as to block a series Gene transcription of lymphokine. In-vitro experiments demonstrate that Tacrolimus is strong-efficacy immunosuppressant, it can inhibit formation of cytotoxic lymphocytes, and allograft rejection is mainly caused by the latter.

This drug inhibits activation of T-cells,TH-cell-dependent B-cells-propagation,and generation of lymphokine such as express of interleukin 2, interleukin 3, β-interferon and interleukin 2 receptor. Tacrolimus can inhibit allograft rejection of skin, heart, kidney and liver, extend survival time of allograft, and this is evidenced in bodies of rodent, dogs, primate and human. It has been widely used for acute and chronic rejection of liver, kidney and bone marrow transplantation.

4、Executive standards
CP、EP、USP

5、Qualification certificate
Registration of "A" status, Chinese GMP; WC license, COPP certificate, CEP certificate, US DMF registration number; MFDS Registration Certificate

6、Packaging size specification

Inner package: single-layers polyethylene bag and aluminum foil bag.

Outer package: Medicinal aluminum bottle.

Packaging size: 500 g/bottle