Rosuvastatin Calcium

Short Description:

API’s Name Indication Specification US DMF  EU DMF  CEP
Rosuvastatin Calcium Hypercholesterolemia In-House/CEP 20705 CEP2015-240


Product Detail

Product Tags

PRODUCT DETAIL

瑞舒伐他汀钙 Rosuvastatin Calcium 147098-20-2 In-House/CEP
    RSM(Crystal) 147118-40-9 In-House
    RSM(Crude) 147118-40-9 In-House
    RSP In-House
    RS-8 147118-36-3 In-House
    RS-8-1 147118-37-4 In-House
    TP-8 131466-61-0 In-House
    TP-11 147118-35-2 In-House
    TP-13 147118-39-6 In-House
    RS-10 289042-12-2 In-House
    RS-11 355806-00-7 In-House

Description

Rosuvastatin Calcium (BANM, JAN, USAN) is known as Rosuvastatin in the US. and a competitive HMG-CoA reductase inhibitor with an IC50 of 11 nM[1]. Rosuvastatin Calcium potently blocks human ether-a-go-go related gene (hERG) current with an IC50 of 195 nM, delayed cardiac repolarization, and thereby prolonged action potential durations (APDs) and corrected QT interval (QTc) intervals[2]. Rosuvastatin Calcium reduces the expression of the mature hERG and the interaction of heat shock protein 70 (Hsp70) with the hERG protein. Rosuvastatin Calcium is very effective in lowering low-density lipoprotein (LDL) cholesterol, triglycerides, and C-reactive protein levels[3].

Further information on drug naming conventions: International Nonproprietary Names.

Important Notice: The Drugs.com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

In the US, Rosuvastatin (rosuvastatin systemic) is a member of the drug class statins and is used to treat Atherosclerosis, High Cholesterol, High Cholesterol - Familial Heterozygous, High Cholesterol - Familial Homozygous, Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa - Elevated LDL, Hyperlipoproteinemia Type IIb - Elevated LDL VLDL, Hyperlipoproteinemia Type III - Elevated beta-VLDL IDL, Hyperlipoproteinemia Type IV - Elevated VLDL, Hypertriglyceridemia and Prevention of Cardiovascular Disease.

Background

A selective, competitive inhibitor of HMG-CoA reductase, that is also antilipemic.

 

Storage

Powder

-20°C

3 years

4°C

2 years
In solvent

-80°C

6 months

-20°C

1 month

Chemical structure

Rosuvastatin Calcium

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

PRODUCTION MANAGEMENT

cpf5
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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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