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Chemistry

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Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect
Molecular Formula
C23H35NaO7
Molecular Weight
446.5  g/mol
InChI Key
VWBQYTRBTXKKOG-IYNICTALSA-M
FDA UNII
3M8608UQ61

Pravastatin
An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).
1 2D Structure

Pravastatin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
2.1.2 InChI
InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14-,16+,17+,18+,19-,20-,22-;/m0./s1
2.1.3 InChI Key
VWBQYTRBTXKKOG-IYNICTALSA-M
2.1.4 Canonical SMILES
CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[Na+]
2.1.5 Isomeric SMILES
CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)[O-])O)O)O.[Na+]
2.2 Other Identifiers
2.2.1 UNII
3M8608UQ61
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Apo Pravastatin

2. Apo-pravastatin

3. Bristacol

4. Cs 514

5. Cs-514

6. Cs514

7. Elisor

8. Eptastatin

9. Lin Pravastatin

10. Lin-pravastatin

11. Lipemol

12. Liplat

13. Lipostat

14. Mevalotin

15. Nu Pravastatin

16. Nu-pravastatin

17. Prareduct

18. Pravachol

19. Pravacol

20. Pravasin

21. Pravastatin

22. Pravastatin Monosodium Salt, (6 Beta)-isomer

23. Pravastatin Sodium Salt

24. Pravastatin Tert Octylamine Salt

25. Pravastatin Tert-octylamine Salt

26. Pravastatin, (6 Beta)-isomer

27. Rms 431

28. Rms-431

29. Rms431

30. Selektine

31. Sodium Salt, Pravastatin

32. Sq 31,000

33. Sq 31000

34. Sq-31,000

35. Sq-31000

36. Sq31,000

37. Sq31000

38. Vasten

2.3.2 Depositor-Supplied Synonyms

1. 81131-70-6

2. Pravachol

3. Mevalotin

4. Selektine

5. Elisor

6. Pravaselect

7. Lipostat

8. Eptastatin Sodium

9. Cs-514

10. Pravastatin Sodium Salt

11. Pravastatin (sodium)

12. Dehypotin Protect

13. Sq-31000

14. Sq-31,000

15. Chebi:8361

16. Bristacol

17. Lipemol

18. Prareduct

19. Pravacol

20. Pravasin

21. 3m8608uq61

22. Nsc-759253

23. Sodium;(3r,5r)-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-[(2s)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

24. Aplactin

25. Lipidal

26. Liprevil

27. Pralidon

28. Pravasine

29. Sanaprav

30. Selipran

31. Vasen

32. Epastatin Sodium

33. Dsstox_cid_27525

34. Dsstox_rid_82395

35. Dsstox_gsid_47525

36. Liplat

37. Vasten

38. Pravastatin, Sodium Salt

39. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoic Acid, Sodium Salt

40. Cas-81131-70-6

41. Pravastatin Natrium Mayrho Fer

42. Sq 31000

43. 3-beta-hydroxycompactin Sodium Salt

44. Drg-0319

45. Chembl690

46. Unii-3m8608uq61

47. Cres Pravastatin

48. Pravachol (tn)

49. Ncgc00095183-01

50. Pravastatin Sodium [usan:usp:jan]

51. Mfcd00887601

52. Pravastatinsodium,(s)

53. Cs-514 Sodium

54. Pravastatin Sodium- Bio-x

55. Schembl3013

56. Sodium (+)-(betar,deltar,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

57. Pravastatin Sodium [mi]

58. Dtxsid6047525

59. Pravastatin Sodium [jan]

60. Hy-b0165a

61. Pravastatin Sodium (jp17/usp)

62. Pravastatin Sodium [usan]

63. Hms2051p05

64. Hms3268l20

65. Hms3413e20

66. Pravastatin Sodium [vandf]

67. Hexahydronaphthalen-1-yl)heptanoate

68. Pravastatin Sodium [mart.]

69. Amy40517

70. Pravastatin Sodium [usp-rs]

71. Pravastatin Sodium [who-dd]

72. Tox21_111474

73. Tox21_300270

74. S3036

75. Akos015896504

76. Akos015964902

77. Ccg-100926

78. Cs-2003

79. Nc00176

80. Nsc 759253

81. Pravastatin Sodium [orange Book]

82. Ncgc00092370-01

83. Ncgc00254232-01

84. Pravastatin Sodium [ep Monograph]

85. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, Monosodium Salt, (1s-(1-alpha(beta-s*,delta-s*),2-alpha,6-alpha,8-beta(r*),8a-alpha))-

86. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1alpha(betas*,deltas*),2alpha,6alpha,8beta(r*),8aalpha))-

87. Bp164292

88. Pravastatin Sodium [usp Monograph]

89. P1796

90. D00893

91. Pravigard Pac Component Pravastatin Sodium

92. Pravastatin Sodium Component Of Pravigard Pac

93. Q27108059

94. Pravastatin Sodium Salt Hydrate, >=98% (hplc), Powder

95. 2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-

96. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-

97. (?r,?r,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Monosodium Salt

98. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoicacid,sodiumsalt

99. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-.beta.,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1.alpha.(.beta.s*,ds*),2.alpha.,6.alpha.,8.beta.(r*),8a.alpha.))-

100. Sodium (+)-(.beta.r,dr,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-.beta.,d,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

101. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate

102. Sodium (3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(2s)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate

2.4 Create Date
2007-11-09
3 Chemical and Physical Properties
Molecular Weight 446.5 g/mol
Molecular Formula C23H35NaO7
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count11
Exact Mass446.22804773 g/mol
Monoisotopic Mass446.22804773 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count31
Formal Charge0
Complexity662
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NamePravachol
PubMed HealthPravastatin (By mouth)
Drug ClassesAntihyperlipidemic
Drug LabelPRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active IngredientPravastatin sodium
Dosage FormTablet
RouteOral
Strength10mg; 80mg; 40mg; 20mg
Market StatusPrescription
CompanyBristol Myers Squibb

2 of 4  
Drug NamePravastatin sodium
Drug LabelPravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active IngredientPravastatin sodium
Dosage FormTablet
Routeoral; Oral
Strength10mg; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyMylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

3 of 4  
Drug NamePravachol
PubMed HealthPravastatin (By mouth)
Drug ClassesAntihyperlipidemic
Drug LabelPRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active IngredientPravastatin sodium
Dosage FormTablet
RouteOral
Strength10mg; 80mg; 40mg; 20mg
Market StatusPrescription
CompanyBristol Myers Squibb

4 of 4  
Drug NamePravastatin sodium
Drug LabelPravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active IngredientPravastatin sodium
Dosage FormTablet
Routeoral; Oral
Strength10mg; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyMylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

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]

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LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"84.00","actualQuantity":"84","unit":"KGS","unitRateFc":"450","totalValueFC":"38273.1","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"3207330","totalValueInUsd":"38273.1","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202305123,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"PRAVASTATIN SODIUM MICRONIZED (BATCH NO.81100200524-27KGS\/81100200424-11KGS\/81100200524-4KGS)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA API BV","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"GLENMARK PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"42.00","actualQuantity":"42","unit":"KGS","unitRateFc":"540","totalValueFC":"22834.8","currency":"USD","unitRateINR":"45684","date":"01-Oct-2024","totalValueINR":"1918728","totalValueInUsd":"22834.8","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"5902371","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST,","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM THE NETHERLAND S Amsterdam, , Netherlands Netherlands","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735756200,"product":"PRAVASTATIN SODIUM USP","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"BIOCON LTD SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BIOCON SEZ BANGALORE","customer":"EMCURE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"85.00","actualQuantity":"85","unit":"KGS","unitRateFc":"579.4","totalValueFC":"49090.1","currency":"USD","unitRateINR":"49800","date":"02-Jan-2025","totalValueINR":"4233000","totalValueInUsd":"49090.1","indian_port":"Biocon-SEZ","hs_no":"29329990","bill_no":"7582183","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BIOCON SEZ BANGALORE","supplierAddress":"PLOT NOS. 2,3,4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMA SDNF India","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"PV202403061,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS) PV202403061,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"105.00","actualQuantity":"105","unit":"KGS","unitRateFc":"450","totalValueFC":"48030.2","currency":"USD","unitRateINR":"39780","date":"07-Feb-2025","totalValueINR":"4176900","totalValueInUsd":"48030.2","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"8218068","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"PV202404066,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS) PV202303094,PRAVASTATIN SODIUM (PHARMACE","address":"SITE 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(PHARMACE","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51232.2","currency":"USD","unitRateINR":"39780","date":"07-Feb-2025","totalValueINR":"4455360","totalValueInUsd":"51232.2","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"8218068","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"PV202404070,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS) PV202303094,PRAVASTATIN SODIUM (PHARMACE","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"119.00","actualQuantity":"119","unit":"KGS","unitRateFc":"450","totalValueFC":"54434.2","currency":"USD","unitRateINR":"39780","date":"07-Feb-2025","totalValueINR":"4733820","totalValueInUsd":"54434.2","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"8218068","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"PV202405080,PRAVASTATIN SODIUM 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BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"BIOCON LTD SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BIOCON SEZ BANGALORE","customer":"EMCURE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"63.10","actualQuantity":"63.1","unit":"KGS","unitRateFc":"567.5","totalValueFC":"36278.8","currency":"USD","unitRateINR":"49800","date":"05-Mar-2025","totalValueINR":"3142380","totalValueInUsd":"36278.8","indian_port":"Biocon-SEZ","hs_no":"29329990","bill_no":"8697500","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BIOCON SEZ BANGALORE","supplierAddress":"PLOT NOS. 2,3,4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMA SDNF India","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741631400,"product":"PRAVASTATIN SODIUM PRAVASTATIN SODIUM","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"TAPI NL BV","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"27.00","actualQuantity":"27","unit":"KGS","unitRateFc":"547.6","totalValueFC":"14986.8","currency":"USD","unitRateINR":"48078.6","date":"11-Mar-2025","totalValueINR":"1298123","totalValueInUsd":"14986.8","indian_port":"Hyderabad Air","hs_no":"29181990","bill_no":"8824224","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"PIET HEINKADE 55 1019 GM AMSTERDAM THE NETHERLANDS SDNF Netherlands","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747852200,"product":"PRAVASTATIN SODIUM PH.EUR","address":"N\/A","city":"","supplier":"BIOCON LTD SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BIOCON SEZ BANGALORE","customer":"VIBONUM TECHNOLOGIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"576.4","totalValueFC":"1169","currency":"USD","unitRateINR":"49800","date":"22-May-2025","totalValueINR":"99600","totalValueInUsd":"1169","indian_port":"Biocon-SEZ","hs_no":"29329990","bill_no":"2210750","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BIOCON SEZ BANGALORE","supplierAddress":"PLOT NOS. 2,3,4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMA SDNF India","customerAddress":"N\/A"}]
21-Feb-2022
22-May-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

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DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

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DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

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DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

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ABOUT THIS PAGE

Looking for 81131-70-6 / Pravastatin API manufacturers, exporters & distributors?

Pravastatin manufacturers, exporters & distributors 1

26

PharmaCompass offers a list of Pravastatin 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 Pravastatin manufacturer or Pravastatin supplier for your needs.

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

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

API | Excipient name

Pravastatin

Synonyms

81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect

Cas Number

81131-70-6

Unique Ingredient Identifier (UNII)

3M8608UQ61

About Pravastatin

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

Tox21_300270 Manufacturers

A Tox21_300270 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tox21_300270, including repackagers and relabelers. The FDA regulates Tox21_300270 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tox21_300270 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 Tox21_300270 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tox21_300270 Suppliers

A Tox21_300270 supplier is an individual or a company that provides Tox21_300270 active pharmaceutical ingredient (API) or Tox21_300270 finished formulations upon request. The Tox21_300270 suppliers may include Tox21_300270 API manufacturers, exporters, distributors and traders.

click here to find a list of Tox21_300270 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tox21_300270 USDMF

A Tox21_300270 DMF (Drug Master File) is a document detailing the whole manufacturing process of Tox21_300270 active pharmaceutical ingredient (API) in detail. Different forms of Tox21_300270 DMFs exist exist since differing nations have different regulations, such as Tox21_300270 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tox21_300270 DMF submitted to regulatory agencies in the US is known as a USDMF. Tox21_300270 USDMF includes data on Tox21_300270's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tox21_300270 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tox21_300270 suppliers with USDMF on PharmaCompass.

Tox21_300270 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 Tox21_300270 Drug Master File in Japan (Tox21_300270 JDMF) empowers Tox21_300270 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 Tox21_300270 JDMF during the approval evaluation for pharmaceutical products. At the time of Tox21_300270 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 Tox21_300270 suppliers with JDMF on PharmaCompass.

Tox21_300270 KDMF

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

Pharmaceutical companies submit a Tox21_300270 Drug Master File in Korea (Tox21_300270 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tox21_300270. The MFDS reviews the Tox21_300270 KDMF as part of the drug registration process and uses the information provided in the Tox21_300270 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tox21_300270 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 Tox21_300270 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tox21_300270 suppliers with KDMF on PharmaCompass.

Tox21_300270 CEP

A Tox21_300270 CEP of the European Pharmacopoeia monograph is often referred to as a Tox21_300270 Certificate of Suitability (COS). The purpose of a Tox21_300270 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tox21_300270 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tox21_300270 to their clients by showing that a Tox21_300270 CEP has been issued for it. The manufacturer submits a Tox21_300270 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tox21_300270 CEP holder for the record. Additionally, the data presented in the Tox21_300270 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tox21_300270 DMF.

A Tox21_300270 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tox21_300270 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 Tox21_300270 suppliers with CEP (COS) on PharmaCompass.

Tox21_300270 WC

A Tox21_300270 written confirmation (Tox21_300270 WC) is an official document issued by a regulatory agency to a Tox21_300270 manufacturer, verifying that the manufacturing facility of a Tox21_300270 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tox21_300270 APIs or Tox21_300270 finished pharmaceutical products to another nation, regulatory agencies frequently require a Tox21_300270 WC (written confirmation) as part of the regulatory process.

click here to find a list of Tox21_300270 suppliers with Written Confirmation (WC) on PharmaCompass.

Tox21_300270 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 Tox21_300270 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tox21_300270 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 Tox21_300270 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 Tox21_300270 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tox21_300270 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tox21_300270 suppliers with NDC on PharmaCompass.

Tox21_300270 GMP

Tox21_300270 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 Tox21_300270 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 Tox21_300270 GMP manufacturer or Tox21_300270 GMP API supplier for your needs.

Tox21_300270 CoA

A Tox21_300270 CoA (Certificate of Analysis) is a formal document that attests to Tox21_300270's compliance with Tox21_300270 specifications and serves as a tool for batch-level quality control.

Tox21_300270 CoA mostly includes findings from lab analyses of a specific batch. For each Tox21_300270 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.

Tox21_300270 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tox21_300270 EP), Tox21_300270 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tox21_300270 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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