Kaiyun体育·(全站)官方网-Perfect Platform

1、Nomenclature
English name：Pioglitazone  Hydrochloride

2、Structural formula

Molecular formula：C₁₉H₂₀N₂O₃S·HCl·HCl      
Molecular mass：392.31      
CAS No.：112529-15-4

3、Mechanism and clinical use:

Pioglitazone hydrochloride is a thiazolidinedione hypoglycemic drugs, Which belongs to an insulin sensitizer. This product has no liver toxicity, and its safety is significantly better than troglitazone. Pioglitazone hydrochloride is absorbed orally and also has the effect of lowering blood lipids.

On September 2017, Pioglitazone Hydrochloride was granted China GMP certificate.

On December 2020, Pioglitazone Hydrochloride was granted “written confirmation for active substance exported to EU”.

4、Executive standards
CP

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

6、Packaging size specification

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

Outer package: Medicinal aluminum bottle

Packaging size: 14 kg/drum

1、Nomenclature
English name： Mycophenolic Acid

2、Structural formula

Molecular formula：C₁₇H₂₀O₆          
Molecular miss：320.34    
CAS No.：24280-93-1

3、Mechanism and clinical use:
As an intermediate of mycophenolate mofetil.

4、Packaging size specification

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

Outer package: fiber drum

Packaging size: 20 kg/drum

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

1、Nomenclature     
English name:Bacitracin

2、Structural formula

Molecular formula of Bacitracin A：C₆₆H₁₀₃N₁₇O₁₆S   
Molecular mass of Bacitracin A：1422.69   
CAS No.：1405-87-4

3、Mechanism and clinical use:

Bacitracin is used as a polypeptide antibiotic. Bacitracin has bactericidal action for Gram-positive bacteria & Gram-negative coccobacteria, diplococcus lanceolatus, staphylococcus, gonococcus, diplococcus intracellularis, leptospiral, etc. The mechanism of action: act on cell wall and affect protoplast, damage cellular plasma membrane and affect permeability.

It is mainly used for infection of penicillin-resistant staphylococcus, also used for skin infection, etc. At a certain concentration, it has a strong antibacterial effect on systemic and local infections caused by Gram-positive bacteria. Its antibacterial spectrum is similar to that of penicillin G. It is often used in combination with polymyxin and neomycin to obtain the antibacterial spectrum.

4、Executive standard

5、Qualification certificate

6、Packaging size specification

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

Outer package: fiber drum.

Packaging size: 10 kg/drum 

1、Nomenclature
English name： Bacitracin Zinc

2、Stuctural formula

Molecular formula：C₆₆H₁₀₃N₁₇O₁₆SZn    
Molecular mass：1486.07   
CAS No.：1405-89-6

3、Mechanism and clinical use:

Bacitracin Zinc is used as a polypeptide antibiotic. Bacitracin Zinc has bactericidal action for Gram-positive bacteria. The mechanism of action: act on cell wall, bind with cell wall of sensitive bacteria, damage cell wall integrity, and give rise to outflow of important materials in cell.

It effectively inhibits gram positive bacteria and some gram negative bacteria. Bacitracin resistance was slow, and there was no cross-resistance with other antibiotics. Promote the growth of livestock and poultry, improve feed conversion rate.

On June 2019, API Bacitracin Zinc was granted “written confirmation for active substance exported to EU”.

4、Executive standards
USP

5、Qualification certificate
WC license, US DMF registration number

6、Packaging size specification

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

Outer package: fiber drum.

Packaging size: 10 kg/drum

1、Nomenclature

English name：Fusidic Acid

2、Structural formula

Molecular formula：C₃₁H₄₈O₆·1/2 H₂O    
Molecular mass：525.7          
CAS No.：6990-06-3

3、Mechanism and clinical use:

Fusidic Acid was extracted in 1962 for the first time by the Danish LEO Pharma from the fermentation broth of Fusidium coccineum. It is a narrow-spectrum, high-efficiency and anti gram-positive bacteria antibiotic widely used in foreign countries. Fusidic Acid, as a typical high efficiency antibiotic, although has been widely used in foreign countries for more than 30 years (few used in domestic clinical), still keeps relatively strong antibacterial activity and very low resistance to most staphylococcus strain, more and more receives people’s attention, and becomes new selection of anti resistant staphylococcus aureus (MRSA).

Fusidic Acid is a kind of antibiotic product for curing infections caused by sensitive bacteria especially staphylococci, such as carious osteitis, blood poisoning, encarditis, repeated infected cystic fibrosis, pneumonia, cutaneo-infection & soft tissue infection, surgery infection & wound infection.

On Feb 2020, API Fusidic Acid was granted “written confirmation for active substance exported to EU”.

On June 2020, API Fusidic Acid was granted CEP certificate.

On Feb 2020，Obtain the EU GMP certificate.

4、Executive standards
CP、EP、IP

5、Qualification certificate
Registration "A" status of raw material packaging, Notification of Approval of marketing application for chemical API, WC, COPP, CEP, EUGMP, US DMF registration number, India Registration certificate, Brazil registration, Malaysia registration, etc.

6、Packaging size specification

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

Outer package: fiber drum.

Packaging size: 20 kg/drum

Sodium Fusidate

1、Nomenclature
English name：Sodium Fusidate

2、Structural formula

Molecular formula：C₃₁H₄₇NaO₆            
Molecular mass：538.70              
CAS No.：751-94-0

3、Mechanism and clinical use:

Sodium fusidate is obtained by extracting fusidic acid from the fermentation broth of fusidium coccineum, and then salting it with sodium hydroxide. It is a narrow-spectrum and highly effective antibiotic against Gram-positive bacteria widely used abroad. Sodium fusidate has a bactericidal effect by inhibiting bacterial protein synthesis and has a potent antibacterial effect against a range of Gram-positive bacteria. It has been paid more and more attention to maintain strong antibacterial activity and low resistance rate against the vast majority of staphylococcal strains, and has become a new choice for resistant staphylococcus aureus.

Sodium Fusidate is a kind of antibiotic product for curing infections caused by sensitive bacteria especially staphylococci, such as carious osteitis, blood poisoning, encarditis, repeated infected cystic fibrosis, pneumonia, cutaneo-infection & soft tissue infection, surgery infection & wound infection.

4、Executive standards
CP、EP、IP

5、Qualification certificate
WC license, COPP certificate, CEP certificate, US DMF registration number, Indian registration certificate.

6、Packaging size specification

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

Outer package: fiber drum.

Packaging size: 15 kg/drum