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Chemistry

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Also known as: 147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt
Molecular Formula
C44H54CaF2N6O12S2
Molecular Weight
1001.1  g/mol
InChI Key
LALFOYNTGMUKGG-BGRFNVSISA-L
FDA UNII
83MVU38M7Q

Rosuvastatin Calcium
A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.
1 2D Structure

Rosuvastatin Calcium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
calcium;(E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate
2.1.2 InChI
InChI=1S/2C22H28FN3O6S.Ca/c2*1-13(2)20-18(10-9-16(27)11-17(28)12-19(29)30)21(14-5-7-15(23)8-6-14)25-22(24-20)26(3)33(4,31)32;/h2*5-10,13,16-17,27-28H,11-12H2,1-4H3,(H,29,30);/q;;+2/p-2/b2*10-9+;/t2*16-,17-;/m11./s1
2.1.3 InChI Key
LALFOYNTGMUKGG-BGRFNVSISA-L
2.1.4 Canonical SMILES
CC(C)C1=NC(=NC(=C1C=CC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C.CC(C)C1=NC(=NC(=C1C=CC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C.[Ca+2]
2.1.5 Isomeric SMILES
CC(C1=NC(=NC(=C1/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C2=CC=C(C=C2)F)N(S(=O)(=O)C)C)C.CC(C1=NC(=NC(=C1/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C2=CC=C(C=C2)F)N(S(=O)(=O)C)C)C.[Ca+2]
2.2 Other Identifiers
2.2.1 UNII
83MVU38M7Q
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Calcium, Rosuvastatin

2. Crestor

3. Rosuvastatin

4. Zd 4522

5. Zd4522

2.3.2 Depositor-Supplied Synonyms

1. 147098-20-2

2. Crestor

3. Rosuvastatin Hemicalcium

4. Fortius

5. Rostar

6. Rosuvastatin Calcium Salt

7. Rosuvastatin Calcium [usan]

8. Rozavel

9. Suvikan

10. Zd4522

11. S-4522

12. Zd 4522

13. Rosuvastatin (as Calcium)

14. Zd4522 (calcium Salt)

15. Zd4522 Calcium

16. Zd-4522 Calcium

17. 83mvu38m7q

18. Chebi:77249

19. Nsc-747274

20. Nsc-758930

21. Rosuvastatincalcium

22. Crestor (tn)

23. Calcium (3r,5s,e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(n-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate

24. Rovista

25. Zd 4522, Calcium Salt

26. Calcium;(e,3r,5s)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate

27. S 4522

28. Unii-83mvu38m7q

29. Provisacor

30. Shufutan

31. Ezallor

32. Zd 4522 Calcium

33. Rosuvastatin Calcium- Bio-x

34. Zd-4522 (calcium Salt)

35. Schembl150740

36. Schembl429217

37. Chembl1744447

38. Dtxsid9045928

39. Rosuvastatin Calcium (jan/usan)

40. Rosuvastatin Calcium [jan]

41. Azd-4522

42. Bcp04131

43. Rosuvastatin Calcium [mart.]

44. S2169

45. Rosuvastatin Calcium [usp-rs]

46. Rosuvastatin Calcium [who-dd]

47. Akos005145896

48. Akos017343682

49. Rosuvastatin Calcium Salt [mi]

50. Ccg-270606

51. Ks-1109

52. Nsc 747274

53. Nsc 758930

54. (s-((r*,s*-(e)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) Amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)

55. (s-(r*,s*-(e)))-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)

56. 6-heptenoic Acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (3r,5s,6e)

57. As-12488

58. Br164378

59. Rosuvastatin Calcium [orange Book]

60. Rosuvastatin Calcium [ep Monograph]

61. Rosuvastatin Calcium [usp Monograph]

62. Roszet Component Rosuvastatin Calcium

63. R0180

64. D01915

65. Rosuvastatin Calcium Component Of Roszet

66. Q-201685

67. Q27146836

68. (s-((r*,s*-(e)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) Amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)

69. (s-(r*,s*-(e)))-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt

70. 6-heptenoic Acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (3r,5s,6e)-

71. Bis((e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(methyl(methylsulfonyl)amino)-pyrimide-5-yl)-(3r,5s)3,5-dihydroxylhept-6-enoic Acid) Calcium

72. Calcium Bis[(3r,5s,6e)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate]

73. Calcium(3r,5s,e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(n-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate

74. Monocalcium Bis((3r,5s,6e)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methanesulfonyl (methyl) Amino] Pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate)

2.3.3 Other Synonyms

1. Rosuvastatin

2. Crestor

2.4 Create Date
2005-10-11
3 Chemical and Physical Properties
Molecular Weight 1001.1 g/mol
Molecular Formula C44H54CaF2N6O12S2
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count20
Rotatable Bond Count18
Exact Mass1000.2835107 g/mol
Monoisotopic Mass1000.2835107 g/mol
Topological Polar Surface Area304 Ų
Heavy Atom Count67
Formal Charge0
Complexity761
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameCrestor
Drug LabelCRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe...
Active IngredientRosuvastatin calcium
Dosage FormTablet
RouteOral
Strength5mg; 10mg; 40mg; 20mg
Market StatusPrescription
CompanyIpr

2 of 4  
Drug NameRosuvastatin calcium
PubMed HealthRosuvastatin (By mouth)
Drug ClassesAntihyperlipidemic
Drug LabelCRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe...
Active IngredientRosuvastatin calcium
Dosage FormTablet
Routeoral; Oral
Strength5mg; 10mg; 40mg; 20mg
Market StatusTentative Approval
CompanyMylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms

3 of 4  
Drug NameCrestor
Drug LabelCRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe...
Active IngredientRosuvastatin calcium
Dosage FormTablet
RouteOral
Strength5mg; 10mg; 40mg; 20mg
Market StatusPrescription
CompanyIpr

4 of 4  
Drug NameRosuvastatin calcium
PubMed HealthRosuvastatin (By mouth)
Drug ClassesAntihyperlipidemic
Drug LabelCRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe...
Active IngredientRosuvastatin calcium
Dosage FormTablet
Routeoral; Oral
Strength5mg; 10mg; 40mg; 20mg
Market StatusTentative Approval
CompanyMylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms

4.2 Drug Indication

Homozygous Familial Hypercholesterolaemia, Prevention of cardiovascular events, Primary combined (mixed) dyslipidaemia, Primary hypercholesterolaemia


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anticholesteremic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)


Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

API Reference Price

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CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"ROSUVASTATIN CALCIUM USP ROSUVASTATIN CALCIUM USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1250.00","actualQuantity":"1250","unit":"KGS","unitRateFc":"495","totalValueFC":"624998.6","currency":"USD","unitRateINR":"43114.5","date":"17-Jan-2025","totalValueINR":"53893125","totalValueInUsd":"624998.6","indian_port":"Hyderabad Air","hs_no":"29189990","bill_no":"7842674","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.518 LAODONG EAST ROAD, CHANGZHOU , JIANGSU PROVINCE CHINA China SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737138600,"product":"ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(RE-IMPORT S\/B NO.6469896 DT.02.01.2024)ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(RE","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"PHARLAB INDUSTRIA FARMACEUTICA S\/A.","supplierCountry":"INDIA","foreign_port":"BELO HORIZONTE, MG","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"32.99","actualQuantity":"32.99","unit":"KGS","unitRateFc":"610.7","totalValueFC":"20350.7","currency":"N\/A","unitRateINR":"53192.7","date":"18-Jan-2025","totalValueINR":"1754828.21","totalValueInUsd":"20350.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7863514","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BELO HORIZONTE, 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FARMACEUTICA S\/A.","supplierCountry":"INDIA","foreign_port":"BELO HORIZONTE, MG","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"610.7","totalValueFC":"6168.8","currency":"N\/A","unitRateINR":"53192.7","date":"18-Jan-2025","totalValueINR":"531927.31","totalValueInUsd":"6168.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7863514","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BELO HORIZONTE, MG","supplierAddress":"OLIMPIO REZENDE DE OLIVEIRA 28, STR EET AMERICO SILVA LAGOA DA PRATA M INAS GERAIS-BRAZIL ZIP CODE-35590-1 Brazil","customerAddress":"PLOT NO. 221, G.I.D.C.,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"ROSUVASTATIN CALCIUM USP ROSUVASTATIN CALCIUM USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1250.00","actualQuantity":"1250","unit":"KGS","unitRateFc":"495","totalValueFC":"624998.6","currency":"USD","unitRateINR":"43114.5","date":"25-Jan-2025","totalValueINR":"53893125","totalValueInUsd":"624998.6","indian_port":"Hyderabad Air","hs_no":"29189990","bill_no":"7995634","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.518 LAODONG EAST ROAD, CHANGZHOU , JIANGSU PROVINCE CHINA China SDNF","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738261800,"product":"ROSUVASTATIN CALCIUM PH.EUR (BATCH NO: RVM1580724) (VIDE SBNO: 3632831 DT:31.08.2024)ROSUVASTATIN CALCIUM PH.EUR (BATCH NO: RVM1580724) (VIDE SB","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"GEDEON RICHTER","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"149.93","actualQuantity":"149.925","unit":"KGS","unitRateFc":"716.4","totalValueFC":"108493.8","currency":"N\/A","unitRateINR":"62400.1","date":"31-Jan-2025","totalValueINR":"9355329.68","totalValueInUsd":"108493.8","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"8123162","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"BUDAPEST X,GYOMROI UT 19-21,HUNGARY ,14,475,BUDAPEST10,PF.27,BUDAPEST-1 475,HUNGARY","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740594600,"product":"ROSUVASTATIN CALCIUM (AMORPHOUS) USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"683.8","totalValueFC":"68994","currency":"USD","unitRateINR":"60000","date":"27-Feb-2025","totalValueINR":"6000000","totalValueInUsd":"68994","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8585951","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740767400,"product":"ROSUVASTATIN CALCIUM (AMORPHOUS) USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"683.8","totalValueFC":"69270","currency":"USD","unitRateINR":"60000","date":"01-Mar-2025","totalValueINR":"6000000","totalValueInUsd":"69270","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8633064","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"ROSUVASTATIN CALCIUM (AMORPHOUS) USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"103.06","actualQuantity":"103.06","unit":"KGS","unitRateFc":"687.3","totalValueFC":"71389.7","currency":"USD","unitRateINR":"60000","date":"24-Mar-2025","totalValueINR":"6183600","totalValueInUsd":"71389.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"9073397","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"}]
01-Jan-2021
31-Mar-2025
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DOSAGE - CAPSULE;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 208647

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 21366

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DOSAGE - TABLET;ORAL - EQ 40MG BASE

USFDA APPLICATION NUMBER - 21366

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ABOUT THIS PAGE

Looking for 147098-20-2 / Rosuvastatin Calcium API manufacturers, exporters & distributors?

Rosuvastatin Calcium manufacturers, exporters & distributors 1

11

PharmaCompass offers a list of Rosuvastatin Calcium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier.

PharmaCompass also assists you with knowing the Rosuvastatin Calcium API Price utilized in the formulation of products. Rosuvastatin Calcium API Price is not always fixed or binding as the Rosuvastatin Calcium Price is obtained through a variety of data sources. The Rosuvastatin Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Rosuvastatin Calcium

Synonyms

147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt

Cas Number

147098-20-2

Unique Ingredient Identifier (UNII)

83MVU38M7Q

About Rosuvastatin Calcium

A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.

Rosuvastatin Manufacturers

A Rosuvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosuvastatin, including repackagers and relabelers. The FDA regulates Rosuvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosuvastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Rosuvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Rosuvastatin Suppliers

A Rosuvastatin supplier is an individual or a company that provides Rosuvastatin active pharmaceutical ingredient (API) or Rosuvastatin finished formulations upon request. The Rosuvastatin suppliers may include Rosuvastatin API manufacturers, exporters, distributors and traders.

click here to find a list of Rosuvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Rosuvastatin USDMF

A Rosuvastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rosuvastatin active pharmaceutical ingredient (API) in detail. Different forms of Rosuvastatin DMFs exist exist since differing nations have different regulations, such as Rosuvastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Rosuvastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Rosuvastatin USDMF includes data on Rosuvastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rosuvastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Rosuvastatin suppliers with USDMF on PharmaCompass.

Rosuvastatin JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Rosuvastatin Drug Master File in Japan (Rosuvastatin JDMF) empowers Rosuvastatin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Rosuvastatin JDMF during the approval evaluation for pharmaceutical products. At the time of Rosuvastatin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Rosuvastatin suppliers with JDMF on PharmaCompass.

Rosuvastatin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Rosuvastatin Drug Master File in Korea (Rosuvastatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rosuvastatin. The MFDS reviews the Rosuvastatin KDMF as part of the drug registration process and uses the information provided in the Rosuvastatin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Rosuvastatin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Rosuvastatin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Rosuvastatin suppliers with KDMF on PharmaCompass.

Rosuvastatin CEP

A Rosuvastatin CEP of the European Pharmacopoeia monograph is often referred to as a Rosuvastatin Certificate of Suitability (COS). The purpose of a Rosuvastatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rosuvastatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rosuvastatin to their clients by showing that a Rosuvastatin CEP has been issued for it. The manufacturer submits a Rosuvastatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rosuvastatin CEP holder for the record. Additionally, the data presented in the Rosuvastatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rosuvastatin DMF.

A Rosuvastatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rosuvastatin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Rosuvastatin suppliers with CEP (COS) on PharmaCompass.

Rosuvastatin WC

A Rosuvastatin written confirmation (Rosuvastatin WC) is an official document issued by a regulatory agency to a Rosuvastatin manufacturer, verifying that the manufacturing facility of a Rosuvastatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rosuvastatin APIs or Rosuvastatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rosuvastatin WC (written confirmation) as part of the regulatory process.

click here to find a list of Rosuvastatin suppliers with Written Confirmation (WC) on PharmaCompass.

Rosuvastatin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Rosuvastatin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Rosuvastatin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Rosuvastatin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Rosuvastatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rosuvastatin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Rosuvastatin suppliers with NDC on PharmaCompass.

Rosuvastatin GMP

Rosuvastatin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Rosuvastatin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Rosuvastatin GMP manufacturer or Rosuvastatin GMP API supplier for your needs.

Rosuvastatin CoA

A Rosuvastatin CoA (Certificate of Analysis) is a formal document that attests to Rosuvastatin's compliance with Rosuvastatin specifications and serves as a tool for batch-level quality control.

Rosuvastatin CoA mostly includes findings from lab analyses of a specific batch. For each Rosuvastatin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Rosuvastatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rosuvastatin EP), Rosuvastatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rosuvastatin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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