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    Chemistry

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    Also known as: Fluvastatin sodium salt, 93957-55-2, Lescol, 94061-80-0, Vastin, (3r,5s)-fluvastatin sodium salt
    Molecular Formula
    C24H25FNNaO4
    Molecular Weight
    433.4  g/mol
    InChI Key
    ZGGHKIMDNBDHJB-NRFPMOEYSA-M
    Fluvastatin Sodium
    An indole-heptanoic acid derivative that inhibits HMG COA REDUCTASE and is used to treat HYPERCHOLESTEROLEMIA. In contrast to other statins, it does not appear to interact with other drugs that inhibit CYP3A4.
    1 2D Structure

    Fluvastatin Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;(E,3R,5S)-7-[3-(4-fluorophenyl)-1-propan-2-ylindol-2-yl]-3,5-dihydroxyhept-6-enoate
    2.1.2 InChI
    InChI=1S/C24H26FNO4.Na/c1-15(2)26-21-6-4-3-5-20(21)24(16-7-9-17(25)10-8-16)22(26)12-11-18(27)13-19(28)14-23(29)30;/h3-12,15,18-19,27-28H,13-14H2,1-2H3,(H,29,30);/q;+1/p-1/b12-11+;/t18-,19-;/m1./s1
    2.1.3 InChI Key
    ZGGHKIMDNBDHJB-NRFPMOEYSA-M
    2.1.4 Canonical SMILES
    CC(C)N1C2=CC=CC=C2C(=C1C=CC(CC(CC(=O)[O-])O)O)C3=CC=C(C=C3)F.[Na+]
    2.1.5 Isomeric SMILES
    CC(C)N1C2=CC=CC=C2C(=C1/C=C/[C@H](C[C@H](CC(=O)[O-])O)O)C3=CC=C(C=C3)F.[Na+]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl)-3,5-dihydroxy-6-heptenoate

    2. Fluindostatin

    3. Fluvastatin

    4. Fluvastatin Sodium Salt

    5. Lescol

    6. Xu 62 320

    7. Xu 62-320

    8. Xu 62320

    9. Xu-62320

    10. Xu62320

    2.2.2 Depositor-Supplied Synonyms

    1. Fluvastatin Sodium Salt

    2. 93957-55-2

    3. Lescol

    4. 94061-80-0

    5. Vastin

    6. (3r,5s)-fluvastatin Sodium Salt

    7. Fluvastatin (sodium)

    8. Fluvastatin

    9. Canef

    10. Sri 62320

    11. Sri-62320

    12. Fluvastatin Sodium (lescol)

    13. (3r,5s)-fluvastatin Sodium

    14. Fractal

    15. Locol

    16. Lescol Xl

    17. Sodium (3r,5s,e)-7-(3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl)-3,5-dihydroxyhept-6-enoate

    18. Sodium;(e,3r,5s)-7-[3-(4-fluorophenyl)-1-propan-2-ylindol-2-yl]-3,5-dihydroxyhept-6-enoate

    19. Dsstox_cid_24758

    20. Dsstox_rid_80451

    21. Dsstox_gsid_44758

    22. Lochol

    23. Fluvastatin Sodium Hydrate

    24. Cranoc

    25. Smr000550480

    26. Xu-62-320

    27. Ab01274723-01

    28. Xilep Xl

    29. Fluindostatin Sodium

    30. Cas-93957-55-2

    31. Prestwick_1032

    32. Fluyastatin Sodium Salt

    33. (+)-fluvastatin Sodium

    34. Fluvastatin Sodium,(s)

    35. Xu 62320 Sodium

    36. Ncgc00164604-01

    37. (relative Stereochemistry)

    38. Fluvastatin Sodium- Bio-x

    39. Schembl41502

    40. Mls001165673

    41. Mls001304715

    42. Mls006010060

    43. Chebi:77602

    44. Fluvastatin For System Suitability

    45. Dtxsid501009854

    46. Hms1570l19

    47. Hms2233n10

    48. (+)-(3r,5s)-fluvastatin Sodium

    49. (3r,5s)-(+)-fluvastatin Sodium

    50. (3s,5r)-7-(3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl)-3,5-dihydroxyhept-6-enoic Acid Sodium Salt

    51. Tox21_112226

    52. Hy-14664a

    53. Mfcd00929076

    54. S1909

    55. Xu-620

    56. Akos016340657

    57. Tox21_112226_1

    58. Ac-6856

    59. Ccg-264930

    60. Cs-1969

    61. Ks-1062

    62. Ncgc00263525-01

    63. (3r,5s)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt

    64. Bf164477

    65. Sw197104-2

    66. H11964

    67. A844750

    68. Q27147203

    69. (3r,5s,6e)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid

    70. (3r,5s,6e)-7-[3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy Hept-6-enoic Acid Sodium Salt

    71. (3r,5s,6e)-7-[3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt

    72. (3s,5r)-rel-7-[3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt

    73. (e)-(3r,5s)-(+)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoic Acid Sodium Salt

    74. (e)-(3r,5s)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoic Acid Sodium Salt

    75. (e)-(3r,5s)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6enoic Acid Sodium Salt

    76. 6-heptenoic Acid, 7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl)-3,5-dihydroxy-, Monosodium Salt, (s-(r*,s*-(e)))-

    77. Sodium (3r,5s,6e)-7-[3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxyhept-6-enoate

    78. Sodium (e)-(3r,5s)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoate

    79. Sodium 7-[3-(4-fluorophenyl)-1-isopropyl-indol-2-yl]-3,5-dihydroxy-hept-6-enoate;fluvastatin Sodium

    80. Sodium(3r,5s,e)-7-(3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl)-3,5-dihydroxyhept-6-enoate

    2.3 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 433.4 g/mol
    Molecular Formula C24H25FNNaO4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count8
    Exact Mass433.16653072 g/mol
    Monoisotopic Mass433.16653072 g/mol
    Topological Polar Surface Area85.5 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity596
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameFluvastatin sodium
    PubMed HealthFluvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormTablet, extended release; Capsule
    Routeoral; Oral
    Strengtheq 20mg base; eq 40mg base; 80mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Par Pharm; Teva Pharms

    2 of 6  
    Drug NameLescol
    PubMed HealthFluvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormCapsule
    RouteOral
    Strengtheq 20mg base; eq 40mg base
    Market StatusPrescription
    CompanyNovartis

    3 of 6  
    Drug NameLescol xl
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormTablet, extended release
    RouteOral
    Strength80mg
    Market StatusPrescription
    CompanyNovartis

    4 of 6  
    Drug NameFluvastatin sodium
    PubMed HealthFluvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormTablet, extended release; Capsule
    Routeoral; Oral
    Strengtheq 20mg base; eq 40mg base; 80mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Par Pharm; Teva Pharms

    5 of 6  
    Drug NameLescol
    PubMed HealthFluvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormCapsule
    RouteOral
    Strengtheq 20mg base; eq 40mg base
    Market StatusPrescription
    CompanyNovartis

    6 of 6  
    Drug NameLescol xl
    Drug LabelLescol (fluvastatin sodium), is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-()-7-[3-(4-fluorophenyl)-1-(1-m...
    Active IngredientFluvastatin sodium
    Dosage FormTablet, extended release
    RouteOral
    Strength80mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Anticholesteremic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors

    National Library of Medicine's Medical Subject Headings. Fluvastatin. Online file (MeSH, 2016). Available from, as of November 1, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    Fluvastatin capsules are indicated: as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb); As an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: 1. LDL-C remains >/= 190 mg/dL or 2. LDL-C remains >/= 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    In patients with clinically evident coronary heart disease (CHD), fluvastatin capsules are indicated to: reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin has reduced total and LDL-cholesterol concentrations in a few patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus (diabetic dyslipidemia), renal insufficiency,cardiac or renal transplantation, or nephrotic syndrome (nephrotic hyperlipidemia). Fluvastatin also has been shown to decrease proteinuria in patients with immunoglobulin A nephropathy. Additional studies are necessary to determine the role, if any, of fluvastatin therapy in patients with these disorders. /NOT included in US product label/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 1849

    4.3 Drug Warning

    Rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with fluvastatin capsules and other drugs in this class.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including fluvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with fluvastatin sodium, promptly interrupt therapy. If an alternate etiology is not found do not restart fluvastatin sodium.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin is secreted into the breast milk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with fluvastatin capsules should be advised not to breastfeed their infants.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin capsules are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Fluvastatin capsules may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Fluvastatin capsules should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, fluvastatin capsules should be discontinued and the patient should be apprised of the potential hazard to the fetus.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    For more Drug Warnings (Complete) data for Fluvastatin (24 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]
    5.2 ATC Code

    C - Cardiovascular system

    C10 - Lipid modifying agents

    C10A - Lipid modifying agents, plain

    C10AA - Hmg coa reductase inhibitors

    C10AA04 - Fluvastatin

    5.3 Absorption, Distribution and Excretion

    /MILK/ Based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma).

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Following oral administration of the capsule, fluvastatin reaches peak concentrations in less than 1 hour. The absolute bioavailability is 24% (range 9% to 50%) after administration of a 10 mg dose.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin is 98% bound to plasma proteins. The mean volume of distribution (VDss) is estimated at 0.35 L/kg. At therapeutic concentrations, the protein binding of fluvastatin is not affected by warfarin, salicylic acid and glyburide.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin administered as fluvastatin sodium extended-release 80 mg tablets reaches peak concentration in approximately 3 hours under fasting conditions, after a low fat meal, or 2.5 hours after a low fat meal. The mean relative bioavailability of the extended-release tablet is approximately 29% (range: 9% to 66%) compared to that of the fluvastatin immediate-release capsule administered under fasting conditions. Administration of a high fat meal delayed the absorption (Tmax: 6 hr) and increased the bioavailability of the extended-release tablet by approximately 50%. However, the maximum concentration of fluvastatin sodium extended-release tablets seen after a high fat meal is less than the peak concentration following a single dose or twice daily dose of the 40 mg fluvastatin capsule.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    For more Absorption, Distribution and Excretion (Complete) data for Fluvastatin (8 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    In vitro data indicate that fluvastatin metabolism involves multiple Cytochrome P450 (CYP) isozymes. CYP2C9 isoenzyme is primarily involved in the metabolism of fluvastatin (approximately 75%), while CYP2C8 and CYP3A4 isoenzymes are involved to a much less extent, i.e., approximately 5% and approximately 20%, respectively.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Fluvastatin is metabolized in the liver, primarily via hydroxylation of the indole ring at the 5 and 6 positions. N-dealkylation and beta-oxidation of the side-chain also occurs. The hydroxy metabolites have some pharmacologic activity, but do not circulate in the blood. Fluvastatin has two enantiomers. Both enantiomers of fluvastatin are metabolized in a similar manner.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    5.5 Biological Half-Life

    The elimination half-life of fluvastatin is approximately 3 hours.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    5.6 Mechanism of Action

    Fluvastatin sodium is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. The inhibition of cholesterol biosynthesis reduces the cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors and thereby increases the uptake of LDL particles. The end result of these biochemical processes is a reduction of the plasma cholesterol concentration.

    NIH; DailyMed. Current Medication Information for Fluvastatin Tablet (Updated: March 2016). Available from, as of November 4, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad8b373-0aec-4efb-8e61-3d8114b31127#i4i_section_id_5f2eb94b-4cdf-4517-9ad8-298e02fe9677

    Statins are largely used in clinics in the treatment of patients with cardiovascular diseases for their effect on lowering circulating cholesterol. Lectin-like oxidized low-density lipoprotein (LOX-1), the primary receptor for ox-LDL, plays a central role in the pathogenesis of atherosclerosis and cardiovascular disorders. We have recently shown that chronic exposure of cells to lovastatin disrupts LOX-1 receptor cluster distribution in plasma membranes, leading to a marked loss of LOX-1 function. Here we investigated the molecular mechanism of statin-mediated LOX-1 inhibition and we demonstrate that all tested statins /including fluvastatin/ are able to displace the binding of fluorescent ox-LDL to LOX-1 by a direct interaction with LOX-1 receptors in a cell-based binding assay. Molecular docking simulations confirm the interaction and indicate that statins completely fill the hydrophobic tunnel that crosses the C-type lectin-like (CTLD) recognition domain of LOX-1. Classical molecular dynamics simulation technique applied to the LOX-1 CTLD, considered in the entire receptor structure with or without a statin ligand inside the tunnel, indicates that the presence of a ligand largely increases the dimer stability. Electrophoretic separation and western blot confirm that different statins binding stabilize the dimer assembly of LOX-1 receptors in vivo. The simulative and experimental results allow us to propose a CTLD clamp motion, which enables the receptor-substrate coupling. These findings reveal a novel and significant functional effect of statins.

    PMID:25950192 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4614984 Biocca S et al; Cell Cycle 14 (10): 1583-95 (2015)

    Epidemiological studies suggest that statins (hydroxymethylglutaryl-CoA reductase inhibitors) could reduce the risk of Alzheimer disease. Although one possible explanation is through an effect on beta-amyloid (Abeta) metabolism, its effect remains to be elucidated. Here, we explored the molecular mechanisms of how statins influence Abeta metabolism. Fluvastatin at clinical doses significantly reduced Abeta and amyloid precursor protein C-terminal fragment (APP-CTF) levels among APP metabolites in the brain of C57BL/6 mice. Chronic intracerebroventricular infusion of lysosomal inhibitors blocked these effects, indicating that up-regulation of the lysosomal degradation of endogenous APP-CTFs is involved in reduced Abeta production. Biochemical analysis suggested that this was mediated by enhanced trafficking of APP-CTFs from endosomes to lysosomes, associated with marked changes of Rab proteins, which regulate endosomal function. In primary neurons, fluvastatin enhanced the degradation of APP-CTFs through an isoprenoid-dependent mechanism. Because our previous study suggests additive effects of fluvastatin on Abeta metabolism, we examined Abeta clearance rates by using the brain efflux index method and found its increased rates at high Abeta levels from brain. As LRP1 in brain microvessels was increased, up-regulation of LRP1-mediated Abeta clearance at the blood-brain barrier might be involved. In cultured brain microvessel endothelial cells, fluvastatin increased LRP1 and the uptake of Abeta, which was blocked by LRP1 antagonists, through an isoprenoid-dependent mechanism. Overall, the present study demonstrated that fluvastatin reduced Abeta level by an isoprenoid-dependent mechanism. ...

    PMID:20472556 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2903370 Shinohara M et al; J Biol Chem 285 (29): 22091-102 (2010)

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    FLUVASTATIN SODIUM

    NDC Package Code : 11712-398

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Biocon Limited

    India
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    Biocon Limited

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    FLUVASTATIN SODIUM

    NDC Package Code : 65727-017

    Start Marketing Date : 2007-01-01

    End Marketing Date : 2025-12-31

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    Biocon Limited

    India
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    Biocon Limited

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    FLUVASTATIN SODIUM

    NDC Package Code : 65727-012

    Start Marketing Date : 2007-01-01

    End Marketing Date : 2025-12-31

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    F.I.S. FABBRICA ITALIANA SINTETICI ...

    Italy
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    F.I.S. FABBRICA ITALIANA SINTETICI ...

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    FLUVASTATIN SODIUM

    NDC Package Code : 48087-0093

    Start Marketing Date : 2010-11-29

    End Marketing Date : 2026-12-31

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    Marketing Category : BULK INGREDIENT

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    MSN Laboratories Private Limited

    India
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    FLUVASTATIN SODIUM

    NDC Package Code : 14501-0009

    Start Marketing Date : 2010-03-25

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

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    TAPI Technology & API Services

    Israel
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Fluvastatin Sodium

    About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

    Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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    Anwita Drugs

    India
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    Fluvastatin Sodium

    About the Company : Anwita Drugs is a technocrat-driven pharmaceutical company with over 28 years of expertise in designing and developing solid oral dosage forms (OSD), nutraceuticals, and dietary su...

    Anwita Drugs is a technocrat-driven pharmaceutical company with over 28 years of expertise in designing and developing solid oral dosage forms (OSD), nutraceuticals, and dietary supplements. We specialize in the design, development, and optimization of solid, semi-solid, and liquid applications using cutting-edge technology. With strong R&D capabilities and a focus on niche product manufacturing, we deliver cost-effective, high-quality solutions. Our mission is to provide integrated, efficient services across multi-therapeutic domains.
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    Guangzhou Tosun Pharmaceutical

    China
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    Fluvastatin Sodium

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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    Teva Pharmaceutical Industries

    Israel
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    Fluvastatin Sodium

    About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

    Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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    Zhejiang Hisun Chemical Co., Ltd.

    China
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    Zhejiang Hisun Chemical Co., Ltd.

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    About the Company : Zhejiang Hisun Chemical Co., Ltd (hereafter called as ”Hisun Chemical), founded in 1998, is a state-holding enterprise invested by State Development & Investment Corporation(SDIC...

    Zhejiang Hisun Chemical Co., Ltd (hereafter called as ”Hisun Chemical), founded in 1998, is a state-holding enterprise invested by State Development & Investment Corporation(SDIC), Zhejiang Hisun Group and ZMC Co., Ltd. The company now covers an area of 312,000 square meters and 35% of its staff members are technicians. With its total assets of nearly USD 60 million, Hisun Chemical has created a niche in agrochemical field through its sustainable researching, marketing efforts and strong distribution network. The company, with its headquarter located in Taizhou, Zhejiang, now has two wholly-owned subsidiary companies , two Sino-foreign joint ventures and one Provincial Hi-tech R&D Centre. Since it was established, Hisun Chemical has already passed ISO9000 & ISO14000 and gained lots of honors like “First AA-level Credit Enterprise of China Pesticide Industry” and “National Hi-tech Enterprise”, etc. Its product, Abamectin has also gained such awards as ”First Prize of S&T Advance Award of China Chemical Industry”, “Major Achievements in National Technologies R&D Program of the 8th Five-year plan of China” and “ Outstanding Project Award in National Technology Innovation Program of the 8th Five-year of China”. Meanwhile, Hisun Chemical has also undertaken the project of Emamectin Benzoate in National Key Technologies R&D program of the 9th Five-year plan of China. And Ascomycin, a kind of its biofungicides, has been listed in “National S&T Pillar Program of Technical Material Development in the 11th Five-year plan of China.” Based on full implement of EHS system and high quality product, Hisun Chemical has been one of the suppliers to many multinational companies, like Bayer, Syngenta, Boehringer Ingelheim and Cheminova, establishing long term business relationship with them. Hisun Chemical exports 85% of its products, ranging from Insecticides, Herbicides to Fungicides, directly to more than 50 countries over the world. Among those products, its patented products such as Oxine copper 33.5% SC & Flazasulfuron have obtained exclusive registration in China. Hisun Chemical adheres to “For Shareholders, For Staff, For Community” as its management purpose, “Honesty, Innovation, Collaboration& Diligence” as its core values, and “Broad Mind& Integrity” as its spirit. With advanced technology, and R&D, Hisun Chemical will strive to become a representative of Agrochemical, Pharmaceutical &Animal Health Field in the 21st century. Our Group-ZHEJIANG HISUN GROUP The original name of Hisun is HaiMen Pharmaceutical Company founded in 1956 and changed her name at 1997 to Zhejiang Hisun Group. Hisun is located in Taizhou, which is a scenic and coastal city at East Sea in China and is part of the southern tip of Shanghai Economic Zone. It contains 100 hectare area and there are more than 3000 employees. Hisun is ranked in the top 520 key enterprises in China, total asset of Hisun has reached RMB 1.6 billion, there is a national R&D center in Hisun and more than 30% of its staff are technician. Hisun has developed into the largest antibiotic and antineoplastic manufacturer and become a reputed one of main chemical production bases in China. There are three main subsidiary companies under Hisun Group which are Hisun pharmaceutical has been listed in SSE, Hisun Chemical and Hisun thermoelectricity. T products of Hisun have been approved and certified by FDA of U.S.A. meanwhile Hisun have got the approvals of ISO9001, ISO9002 and ISO14000. Hisun exports 80% of its products to approximately 100 countries all over the world, the products performance has been approved by domestic and international consumers.
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    API Reference Price

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    12-Feb-2022
    25-Sep-2025
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    ABOUT THIS PAGE

    Looking for 93957-54-1 / Fluvastatin Sodium API manufacturers, exporters & distributors?

    Fluvastatin Sodium manufacturers, exporters & distributors 1

    53

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

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

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

    API | Excipient name

    Fluvastatin Sodium

    Synonyms

    Fluvastatin sodium salt, 93957-55-2, Lescol, 94061-80-0, Vastin, (3r,5s)-fluvastatin sodium salt

    Cas Number

    93957-54-1

    About Fluvastatin Sodium

    An indole-heptanoic acid derivative that inhibits HMG COA REDUCTASE and is used to treat HYPERCHOLESTEROLEMIA. In contrast to other statins, it does not appear to interact with other drugs that inhibit CYP3A4.

    Fluvastatin Sodium Manufacturers

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

    Fluvastatin Sodium Suppliers

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

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

    Fluvastatin Sodium USDMF

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

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

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

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

    Fluvastatin Sodium KDMF

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

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

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

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

    Fluvastatin Sodium CEP

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

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

    Fluvastatin Sodium WC

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

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

    Fluvastatin Sodium 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 Fluvastatin Sodium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Fluvastatin Sodium GMP

    Fluvastatin Sodium 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 Fluvastatin Sodium 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 Fluvastatin Sodium GMP manufacturer or Fluvastatin Sodium GMP API supplier for your needs.

    Fluvastatin Sodium CoA

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

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

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