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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

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 Formula	C₂₄H₂₅FNNaO₄
Molecular Weight	433.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	8
Exact Mass	433.16653072 g/mol
Monoisotopic Mass	433.16653072 g/mol
Topological Polar Surface Area	85.5 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	596
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Fluvastatin sodium
PubMed Health	Fluvastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Tablet, extended release; Capsule
Route	oral; Oral
Strength	eq 20mg base; eq 40mg base; 80mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Par Pharm; Teva Pharms

2 of 6
Drug Name	Lescol
PubMed Health	Fluvastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Capsule
Route	Oral
Strength	eq 20mg base; eq 40mg base
Market Status	Prescription
Company	Novartis

3 of 6
Drug Name	Lescol xl
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Tablet, extended release
Route	Oral
Strength	80mg
Market Status	Prescription
Company	Novartis

4 of 6
Drug Name	Fluvastatin sodium
PubMed Health	Fluvastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Tablet, extended release; Capsule
Route	oral; Oral
Strength	eq 20mg base; eq 40mg base; 80mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Par Pharm; Teva Pharms

5 of 6
Drug Name	Lescol
PubMed Health	Fluvastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Capsule
Route	Oral
Strength	eq 20mg base; eq 40mg base
Market Status	Prescription
Company	Novartis

6 of 6
Drug Name	Lescol xl
Drug Label	Lescol (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 Ingredient	Fluvastatin sodium
Dosage Form	Tablet, extended release
Route	Oral
Strength	80mg
Market Status	Prescription
Company	Novartis

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/

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

5.5 Biological Half-Life

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

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.

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 AMORPHOUS

GDUFA

DMF Review : N/A

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DMF Number : 24091

Submission : 2010-08-20

Status : Active

Type : II

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FLUVASTATIN SODIUM

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Rev. Date : 2012-11-23

Pay. Date : 2012-11-08

DMF Number : 19296

Submission : 2006-03-24

Status : Active

Type : II

03

Aurobindo Pharma Ltd

India

India

PharmaVenue

Not Confirmed

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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(AMORPHOUS) BATCH NO:BS24003317\/BF24005066","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"M\/S.....","customerCountry":"SPAIN","quantity":"61.65","actualQuantity":"61.65","unit":"KGS","unitRateFc":"730","totalValueFC":"46171.9","currency":"EUR","unitRateINR":63201.309164639089,"date":"26-Nov-2024","totalValueINR":"3896360.71","totalValueInUsd":"46171.9","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5928337","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"FLUVASTATIN SODIUM","year":"2021","qtr":"Q2","strtotime":1619375400,"product":"FLUVASTATIN SODIUM, USP (HYDRATE) MATERIAL: 7-991(FLUVASTATIN SODIUM.)","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"VIATRIS","supplierCountry":"CANADA","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"VIATRIS","customerCountry":"INDIA","quantity":"34.40","actualQuantity":"34.4","unit":"KGS","unitRateFc":"2700","totalValueFC":"95002","currency":"USD","unitRateINR":"205605","date":"26-Apr-2021","totalValueINR":"7072812","totalValueInUsd":"95002","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3708226","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"FLUVASTATIN SODIUM","year":"2021","qtr":"Q2","strtotime":1619375400,"product":"FLUVASTATIN SODIUM, USP (HYDRATE) MATERIAL: 7-991(FLUVASTATIN SODIUM.)","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"VIATRIS","supplierCountry":"CANADA","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"VIATRIS","customerCountry":"INDIA","quantity":"35.10","actualQuantity":"35.1","unit":"KGS","unitRateFc":"2700","totalValueFC":"96935.2","currency":"USD","unitRateINR":"205605","date":"26-Apr-2021","totalValueINR":"7216735.5","totalValueInUsd":"96935.2","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3708226","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"FLUVASTATIN SODIUM","year":"2021","qtr":"Q2","strtotime":1619375400,"product":"FLUVASTATIN SODIUM, USP (HYDRATE) MATERIAL: 7-991(FLUVASTATIN SODIUM.)","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"VIATRIS","supplierCountry":"CANADA","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"VIATRIS","customerCountry":"INDIA","quantity":"35.20","actualQuantity":"35.2","unit":"KGS","unitRateFc":"2700","totalValueFC":"97211.4","currency":"USD","unitRateINR":"205605","date":"26-Apr-2021","totalValueINR":"7237296","totalValueInUsd":"97211.4","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3708226","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1625509800,"product":"FLUVASTATIN SODIUM, USP (HYDRATE)","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"VIATRIS","supplierCountry":"CANADA","foreign_port":"PHILADELPHIA METROP","customer":"VIATRIS","customerCountry":"INDIA","quantity":"18.20","actualQuantity":"18.2","unit":"KGS","unitRateFc":"2700","totalValueFC":"49649.8","currency":"USD","unitRateINR":"203310","date":"06-Jul-2021","totalValueINR":"3700242","totalValueInUsd":"49649.8","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"4586502","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"PHILADELPHIA METROP","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1638124200,"product":"FLUVASTATIN SODIUM CP","address":"DOOR NO. 5-35\/189\/A, SURVEY NO. 390 IST FLR,TYPE 111,INDUSTRIAL ESTATE","city":"KUKATPALLY,HYDERABAD,TS","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUREX LABORATORIES PRIVATE ","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1515","totalValueFC":"5490.6","currency":"USD","unitRateINR":"136296.6","date":"29-Nov-2021","totalValueINR":"408889.77","totalValueInUsd":"5490.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"6453506","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"DOOR NO. 5-35\/189\/A, SURVEY NO. 390 IST FLR,TYPE 111,INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689359400,"product":"FLUVASTATIN SODIUM- FLUVASTATIN NA HYDRATE","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"CANADA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"83.20","actualQuantity":"83.2","unit":"KGS","unitRateFc":"3200","totalValueFC":"306592.9","currency":"EUR","unitRateINR":"302869.6","date":"15-Jul-2023","totalValueINR":"25198726.48","totalValueInUsd":"306592.9","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

19 API Suppliers

10 USDMF

8 CEP/COS

3 JDMF

6 EU WC

1 KDMF

7 NDC API

4 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers

11 FDA Orange Book

5 Europe

2 Canada

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EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders

55 Coating Systems & Additives

38 Direct Compression

32 Controlled & Modified Release

31 Thickeners and Stabilizers

24 Disintegrants & Superdisintegrants

24 Granulation

23 Solubilizers

17 Topical

17 Lubricants & Glidants

15 Co-Processed Excipients

13 Film Formers & Plasticizers

12 Parenteral

11 Chewable & Orodispersible Aids

10 Taste Masking

9 Empty Capsules

7 Emulsifying Agents