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    Chemistry

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    Also known as: 134523-00-5, Cardyl, Lipitor, 110862-48-1, Torvast, Atorvastatin calcium
    Molecular Formula
    C33H35FN2O5
    Molecular Weight
    558.6  g/mol
    InChI Key
    XUKUURHRXDUEBC-KAYWLYCHSA-N
    FDA UNII
    A0JWA85V8F
    Atorvastatin
    A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.
    Atorvastatin is a HMG-CoA Reductase Inhibitor. The mechanism of action of atorvastatin is as a Hydroxymethylglutaryl-CoA Reductase Inhibitor.
    1 2D Structure

    Atorvastatin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid
    2.1.2 InChI
    InChI=1S/C33H35FN2O5/c1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40/h3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40)/t26-,27-/m1/s1
    2.1.3 InChI Key
    XUKUURHRXDUEBC-KAYWLYCHSA-N
    2.1.4 Canonical SMILES
    CC(C)C1=C(C(=C(N1CCC(CC(CC(=O)O)O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC=C4
    2.1.5 Isomeric SMILES
    CC(C)C1=C(C(=C(N1CC[C@H](C[C@H](CC(=O)O)O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC=C4
    2.2 Other Identifiers
    2.2.1 UNII
    A0JWA85V8F
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (3r,5r)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1h-pyrrol-1-yl)-3,5-dihydroxyheptanoic Acid

    2. Atorvastatin Calcium

    3. Atorvastatin Calcium Anhydrous

    4. Atorvastatin Calcium Hydrate

    5. Atorvastatin Calcium Trihydrate

    6. Atorvastatin, Calcium Salt

    7. Ci 981

    8. Ci-981

    9. Ci981

    10. Lipitor

    11. Liptonorm

    2.3.2 Depositor-Supplied Synonyms

    1. 134523-00-5

    2. Cardyl

    3. Lipitor

    4. 110862-48-1

    5. Torvast

    6. Atorvastatin Calcium

    7. Rel-atorvastatin

    8. (3r,5r)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1h-pyrrol-1-yl)-3,5-dihydroxyheptanoic Acid

    9. Atorvastatin (inn)

    10. Ci 981

    11. Lipitor (tn)

    12. Tozalip

    13. Xavator

    14. (3r,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    15. A0jwa85v8f

    16. Chembl1487

    17. (r-(r*,r*))-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-1h-pyrrole-1-heptanoic Acid

    18. Chebi:39548

    19. (3r,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1h-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    20. 134523-03-8

    21. Atorvastatin [inn]

    22. Atorvastatin [inn:ban]

    23. 1h-pyrrole-1-heptanoic Acid, 2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-, (r-(r*,r*))-

    24. 7-[2-(4-fluoro-phenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoyl-pyrrol-1-yl]- 3,5-dihydroxy-heptanoic Acid

    25. Atorvastatin Calcium Salt

    26. Atorvastatina

    27. Atorvastatine

    28. Atrovastin

    29. Atofast

    30. Atorcor

    31. Atorlip

    32. Lipilou

    33. Lipinon

    34. Atorin

    35. Ator

    36. Lipitor(tm)

    37. (3r,5r)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1h-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    38. (3r,5r)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxy-heptanoic Acid

    39. (3r,5r)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1h-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    40. Sortis (tn)

    41. Ccris 7159

    42. Hsdb 7039

    43. Ncgc00159458-03

    44. Unii-a0jwa85v8f

    45. Atorvastatinum

    46. (betar,deltar)-2-(p-fluorophenyl)-beta,delta-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoic Acid

    47. Atorvastatin & Primycin

    48. Atorvastatin [mi]

    49. Dsstox_cid_9868

    50. Atorvastatin [hsdb]

    51. Schembl3831

    52. Atorvastatin [vandf]

    53. Dsstox_rid_78825

    54. Dsstox_gsid_29868

    55. Atorvastatin [who-dd]

    56. Bidd:gt0336

    57. Atorvastatin (relative Stereo)

    58. Gtpl2949

    59. Dtxsid8029868

    60. Bdbm22164

    61. Dtxsid60274003

    62. Hms3715l05

    63. Hms3886c20

    64. Lipilou; Tozalip; Torvast; Cardyl

    65. (3s,5s)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    66. Act03225

    67. Hy-b0589

    68. Zinc3920719

    69. Tox21_302417

    70. Mfcd00899261

    71. S5715

    72. Akos000281127

    73. Ac-9386

    74. Ccg-221172

    75. Db01076

    76. Mrf-0000761

    77. Ncgc00159458-02

    78. Ncgc00159458-20

    79. Ncgc00255181-01

    80. (3r,5r)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoylpyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    81. 1h-pyrrole-1-heptanoic Acid, 2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-, (betar,deltar)-

    82. 7-[2-(4-fluoro-phenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoyl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic Acid

    83. As-35260

    84. Cas-134523-00-5

    85. C06834

    86. D07474

    87. 523a005

    88. A802259

    89. A806791

    90. A806793

    91. Q668093

    92. Sr-01000872702

    93. Sr-01000872702-1

    94. Brd-k69726342-001-02-6

    95. Atorvastatin Is Known As An Hmg-coa Reductase Inhibitor.

    96. (.beta.r,.delta.r)-2-(p-fluorophenyl)-.beta.,.delta.-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoic Acid

    97. (3r,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic Acid

    98. (3r,5r)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoyl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic Acid

    99. (3r,5r)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-4-phenyl-2-(propan-2-yl)-1h-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid

    100. 1h-pyrrole-1-heptanoic Acid, 2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-, (r-(r*,r*))-

    101. Sodium 7-[5-(4-fluorophenyl)-2-isopropyl-4-phenyl-3-(phenylcarbamoyl)-2,3-dihydropyrrol-1-yl]-3,5-dihydroxy-heptanoate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 558.6 g/mol
    Molecular Formula C33H35FN2O5
    XLogP35
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count12
    Exact Mass558.25300038 g/mol
    Monoisotopic Mass558.25300038 g/mol
    Topological Polar Surface Area112 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity822
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLipitor
    PubMed HealthAtorvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLIPITOR (atorvastatin calcium) is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting...
    Active IngredientAtorvastatin calcium
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 80mg base; eq 10mg base
    Market StatusPrescription
    CompanyPfizer

    2 of 2  
    Drug NameLipitor
    PubMed HealthAtorvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelLIPITOR (atorvastatin calcium) is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting...
    Active IngredientAtorvastatin calcium
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 80mg base; eq 10mg base
    Market StatusPrescription
    CompanyPfizer

    4.2 Therapeutic Uses

    Anticholesteremic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors

    National Library of Medicine's Medical Subject Headings. Atorvastatin. Online file (MeSH, 2016). Available from, as of October 28, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Lipitor is indicated to: Reduce the risk of myocardial infarction; Reduce the risk of stroke; Reduce the risk for revascularization procedures and angina. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, Lipitor is indicated to: Reduce the risk of myocardial infarction; Reduce the risk of stroke. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    In patients with clinically evident coronary heart disease, Lipitor is indicated to: Reduce the risk of non-fatal myocardial infarction; Reduce the risk of fatal and non-fatal stroke; Reduce the risk for revascularization procedures; Reduce the risk of hospitalization for congestive heart failure (CHF); Reduce the risk of angina. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    For more Therapeutic Uses (Complete) data for ATORVASTATIN (15 total), please visit the HSDB record page.

    4.3 Drug Warning

    Lipitor is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid lowering drugs offer no benefit during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    Statins may cause fetal harm when administered to a pregnant woman. Lipitor should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the woman becomes pregnant while taking Lipitor, it should be discontinued immediately and the patient advised again as to the potential hazards to the fetus and the lack of known clinical benefit with continued use during pregnancy.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing rat pups had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk. Animal breast milk drug levels may not accurately reflect human breast milk levels. Because another drug in this class passes into human milk and because statins have a potential to cause serious adverse reactions in nursing infants, women requiring Lipitor treatment should be advised not to nurse their infants.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    Myopathy (defined as muscle aches or weakness in conjunction with increases in creatine kinase [CK, creatine phosphokinase, CPK] concentrations exceeding 10 times the upper limit of normal [ULN]) has been reported occasionally in patients receiving statins, including atorvastatin. Rhabdomyolysis with acute renal failure secondary to myoglobinuria also has been reported rarely in patients receiving statins, including atorvastatin.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 1844

    For more Drug Warnings (Complete) data for ATORVASTATIN (33 total), please visit the HSDB record page.

    4.4 Drug Indication

    Atorvastatin is indicated for the treatment of several types of dyslipidemias, including primary hyperlipidemia and mixed dyslipidemia in adults, hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, and heterozygous familial hypercholesterolemia in adolescent patients with failed dietary modifications. Dyslipidemia describes an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis. Atorvastatin is indicated, in combination with dietary modifications, to prevent cardiovascular events in patients with cardiac risk factors and/or abnormal lipid profiles. Atorvastatin can be used as a preventive agent for myocardial infarction, stroke, revascularization, and angina, in patients without coronary heart disease but with multiple risk factors and in patients with type 2 diabetes without coronary heart disease but multiple risk factors. Atorvastatin may be used as a preventive agent for non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure and angina in patients with coronary heart disease. Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD. Statin-indicated conditions include diabetes mellitus, clinical atherosclerosis (including myocardial infarction, acute coronary syndromes, stable angina, documented coronary artery disease, stroke, trans ischemic attack (TIA), documented carotid disease, peripheral artery disease, and claudication), abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Atorvastatin is an oral antilipemic agent that reversibly inhibits HMG-CoA reductase. It lowers total cholesterol, low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), non-high density lipoprotein-cholesterol (non-HDL-C), and triglyceride (TG) plasma concentrations while increasing HDL-C concentrations. High LDL-C, low HDL-C and high TG concentrations in the plasma are associated with increased risk of atherosclerosis and cardiovascular disease. The total cholesterol to HDL-C ratio is a strong predictor of coronary artery disease, and high ratios are associated with a higher risk of disease. Increased levels of HDL-C are associated with lower cardiovascular risk. By decreasing LDL-C and TG and increasing HDL-C, atorvastatin reduces the risk of cardiovascular morbidity and mortality. Elevated cholesterol levels (and high low-density lipoprotein (LDL) levels in particular) are an important risk factor for the development of CVD. Clinical studies have shown that atorvastatin reduces LDL-C and total cholesterol by 36-53%. In patients with dysbetalipoproteinemia, atorvastatin reduced the levels of intermediate-density lipoprotein cholesterol. It has also been suggested that atorvastatin can limit the extent of angiogenesis, which can be useful in the treatment of chronic subdural hematoma. **Myopathy/Rhabdomyolysis** Atorvastatin, like other HMG-CoA reductase inhibitors, is associated with a risk of drug-induced myopathy characterized by muscle pain, tenderness, or weakness in conjunction with elevated levels of creatine kinase (CK). Myopathy often manifests as rhabdomyolysis with or without acute renal failure secondary to myoglobinuria. The risk of statin-induced myopathy is dose-related, and the symptoms of myopathy are typically resolved upon drug discontinuation. Results from observational studies suggest that 10-15% of people taking statins may experience muscle aches at some point during treatment. **Liver Dysfunction** Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (> 3 times the upper limit of normal [ULN] occurring on two or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin in clinical trials. This effect appears to be dose-related. **Endocrine Effects** Statins are associated with a risk of increased serum HbA1c and glucose levels. An _in vitro_ study demonstrated a dose-dependent cytotoxic effect on human pancreatic islet cells following treatment with atorvastatin. Moreover, insulin secretion rates decreased relative to control. HMG-CoA reductase inhibitors interfere with cholesterol synthesis and may theoretically interfere with the production of adrenal and/or gonadal steroids. Clinical studies with atorvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not affect plasma cortisol concentrations, basal plasma testosterone concentration, or adrenal reserve. However, the effect of statins on male fertility has not been fully investigated. The effects of statins on the pituitary-gonadal axis in premenopausal women are unknown. **Cardiovascular** Significant decreases in circulating ubiquinone levels in patients treated with atorvastatin and other statins have been observed. The clinical significance of a potential long-term statin-induced deficiency of ubiquinone has not been established. It has been reported that a decrease in myocardial ubiquinone levels could lead to impaired cardiac function in patients with borderline congestive heart failure. **Lipoprotein A** In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by the concomitant increase in Lp(a) lipoprotein concentrations. Present knowledge suggests the importance of high Lp(a) levels as an emerging risk factor for coronary heart disease. Further studies have demonstrated statins affect Lp(a) levels differently in patients with dyslipidemia depending on their apo(a) phenotype; statins increase Lp(a) levels exclusively in patients with the low molecular weight apo(a) phenotype.

    5.2 MeSH Pharmacological Classification

    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.)

    Anticholesteremic Agents

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

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ATORVASTATIN
    5.3.2 FDA UNII
    A0JWA85V8F
    5.3.3 Pharmacological Classes
    Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]
    5.4 ATC Code

    C10AA05

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    C - Cardiovascular system

    C10 - Lipid modifying agents

    C10A - Lipid modifying agents, plain

    C10AA - Hmg coa reductase inhibitors

    C10AA05 - Atorvastatin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Atorvastatin presents a dose-dependent and non-linear pharmacokinetic profile. It is very rapidly absorbed after oral administration. After the administration of a dose of 40 mg, its peak plasma concentration of 28 ng/ml is reached 1-2 hours after initial administration with an AUC of about 200 ngh/ml. Atorvastatin undergoes extensive first-pass metabolism in the wall of the gut and the liver, resulting in an absolute oral bioavailability of 14%. Plasma atorvastatin concentrations are lower (approximately 30% for Cmax and AUC) following evening drug administration compared with morning. However, LDL-C reduction is the same regardless of the time of day of drug administration. Administration of atorvastatin with food results in prolonged Tmax and a reduction in Cmax and AUC. Breast Cancer Resistance Protein (BCRP) is a membrane-bound protein that plays an important role in the absorption of atorvastatin. Evidence from pharmacogenetic studies of c.421C>A single nucleotide polymorphisms (SNPs) in the gene for BCRP has demonstrated that individuals with the 421AA genotype have reduced functional activity and 1.72-fold higher AUC for atorvastatin compared to study individuals with the control 421CC genotype. This has important implications for the variation in response to the drug in terms of efficacy and toxicity, particularly as the BCRP c.421C>A polymorphism occurs more frequently in Asian populations than in Caucasians. Other statin drugs impacted by this polymorphism include [fluvastatin], [simvastatin], and [rosuvastatin]. Genetic differences in the OATP1B1 (organic-anion-transporting polypeptide 1B1) hepatic transporter encoded by the SCLCO1B1 gene (Solute Carrier Organic Anion Transporter family member 1B1) have been shown to impact atorvastatin pharmacokinetics. Evidence from pharmacogenetic studies of the c.521T>C single nucleotide polymorphism (SNP) in the gene encoding OATP1B1 (SLCO1B1) demonstrated that atorvastatin AUC was increased 2.45-fold for individuals homozygous for 521CC compared to homozygous 521TT individuals. Other statin drugs impacted by this polymorphism include [simvastatin], [pitavastatin], [rosuvastatin], and [pravastatin].

    Route of Elimination

    Atorvastatin and its metabolites are mainly eliminated in the bile without enterohepatic recirculation. The renal elimination of atorvastatin is very minimal and represents less than 1% of the eliminated dose.

    Volume of Distribution

    The reported volume of distribution of atorvastatin is of 380 L.

    Clearance

    The registered total plasma clearance of atorvastatin is of 625 ml/min.

    /MILK/ In a separate experiment, a single dose of 10 mg/kg atorvastatin administered to female Wistar rats on gestation day 19 or lactation day 13 provided evidence of placental transfer and excretion into the milk.

    PMID:9520344 Henck JW et al; Toxicol Sci 41 (1): 88-99 (1998)

    Lipitor and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism; however, the drug does not appear to undergo enterohepatic recirculation. ... Less than 2% of a dose of Lipitor is recovered in urine following oral administration.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    /MILK/ It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing rat pups had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    Mean volume of distribution of Lipitor is approximately 381 liters. Lipitor is >/= 98% bound to plasma proteins. A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

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

    5.6 Metabolism/Metabolites

    Atorvastatin is highly metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products, primarily by Cytochrome P450 3A4 in the intestine and liver. Atorvastatin's metabolites undergo further lactonization via the formation of acyl glucuronide intermediates by the enzymes UGT1A1 and UGT1A3. These lactones can be hydrolyzed back to their corresponding acid forms and exist in equilibirum. _In vitro_ inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.

    Lipitor is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. In vitro inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase by ortho- and parahydroxylated metabolites is equivalent to that of Lipitor. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. In vitro studies suggest the importance of Lipitor metabolism by cytochrome P450 3A4, consistent with increased plasma concentrations of Lipitor in humans following co-administration with erythromycin, a known inhibitor of this isozyme. In animals, the ortho-hydroxy metabolite undergoes further glucuronidation.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    The active forms of all marketed hydroxymethylglutaryl (HMG)-CoA reductase inhibitors share a common dihydroxy heptanoic or heptenoic acid side chain. In this study, we present evidence for the formation of acyl glucuronide conjugates of the hydroxy acid forms of simvastatin (SVA), atorvastatin (AVA), and cerivastatin (CVA) in rat, dog, and human liver preparations in vitro and for the excretion of the acyl glucuronide of SVA in dog bile and urine. Upon incubation of each statin (SVA, CVA or AVA) with liver microsomal preparations supplemented with UDP-glucuronic acid, two major products were detected. Based on analysis by high-pressure liquid chromatography, UV spectroscopy, and/or liquid chromatography (LC)-mass spectrometry analysis, these metabolites were identified as a glucuronide conjugate of the hydroxy acid form of the statin and the corresponding delta-lactone. By means of an LC-NMR technique, the glucuronide structure was established to be a 1-O-acyl-beta-D-glucuronide conjugate of the statin acid. The formation of statin glucuronide and statin lactone in human liver microsomes exhibited modest intersubject variability (3- to 6-fold; n = 10). Studies with expressed UDP glucuronosyltransferases (UGTs) revealed that both UGT1A1 and UGT1A3 were capable of forming the glucuronide conjugates and the corresponding lactones for all three statins. Kinetic studies of statin glucuronidation and lactonization in liver microsomes revealed marked species differences in intrinsic clearance (CL(int)) values for SVA (but not for AVA or CVA), with the highest CL(int) observed in dogs, followed by rats and humans. Of the statins studied, SVA underwent glucuronidation and lactonization in human liver microsomes, with the lowest CL(int) (0.4 uL/min/mg of protein for SVA versus approximately 3 uL/min/mg of protein for AVA and CVA). Consistent with the present in vitro findings, substantial levels of the glucuronide conjugate (approximately 20% of dose) and the lactone form of SVA [simvastatin (SV); approximately 10% of dose] were detected in bile following i.v. administration of [(14)C]SVA to dogs. The acyl glucuronide conjugate of SVA, upon isolation from an in vitro incubation, underwent spontaneous cyclization to SV. Since the rate of this lactonization was high under conditions of physiological pH, the present results suggest that the statin lactones detected previously in bile and/or plasma following administration of SVA to animals or of AVA or CVA to animals and humans, might originate, at least in part, from the corresponding acyl glucuronide conjugates. Thus, acyl glucuronide formation, which seems to be a common metabolic pathway for the hydroxy acid forms of statins, may play an important, albeit previously unrecognized, role in the conversion of active HMG-CoA reductase inhibitors to their latent delta-lactone forms.

    PMID:11950779 Prueksaritanont T et al; Drug Metab Dispos 30 (5): 505-12 (2002)

    The genetic variation underlying atorvastatin (ATV) pharmacokinetics was evaluated in a Mexican population. Aims of this study were: 1) to reveal the frequency of 87 polymorphisms in 36 genes related to drug metabolism in healthy Mexican volunteers, 2) to evaluate the impact of these polymorphisms on ATV pharmacokinetics, 3) to classify the ATV metabolic phenotypes of healthy volunteers, and 4) to investigate a possible association between genotypes and metabolizer phenotypes. A pharmacokinetic study of ATV (single 80-mg dose) was conducted in 60 healthy male volunteers. ATV plasma concentrations were measured by high-performance liquid chromatography mass spectrometry. Pharmacokinetic parameters were calculated by the non-compartmental method. The polymorphisms were determined with the PHARMAchip microarray and the TaqMan probes genotyping assay. Three metabolic phenotypes were found in our population: slow, normal, and rapid. Six gene polymorphisms were found to have a significant effect on ATV pharmacokinetics: MTHFR (rs1801133), DRD3 (rs6280), GSTM3 (rs1799735), TNFa (rs1800629), MDR1 (rs1045642), and SLCO1B1 (rs4149056). The combination of MTHFR, DRD3 and MDR1 polymorphisms associated with a slow ATV metabolizer phenotype.

    PMID:26857559 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746878 Leon-Cachon RB et al; BMC Cancer16: 74 (2016)

    Atorvastatin has known human metabolites that include 7-[2-(4-Fluorophenyl)-4-[(2-hydroxyphenyl)carbamoyl]-3-phenyl-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid and 7-[2-(4-Fluorophenyl)-4-[(4-hydroxyphenyl)carbamoyl]-3-phenyl-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    The half-life of atorvastatin is 14 hours while the half-life of its metabolites can reach up to 30 hours.

    /MILK/ ...After administration to lactating rats, radioactivity in milk reached the maximum of 17.1 ng eq./mL at 6.0 hr and thereafter declined with a half-life of 7.8 hr.

    Nemoto H et al; Yakuri To Chiryo 26 (7): 79-96 (1998)

    Mean plasma elimination half-life of Lipitor in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    5.8 Mechanism of Action

    Atorvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis. Atorvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low-density lipoprotein (LDL) receptors, which increases hepatic uptake of LDL. Atorvastatin also reduces Very-Low-Density Lipoprotein-Cholesterol (VLDL-C), serum triglycerides (TG) and Intermediate Density Lipoproteins (IDL), as well as the number of apolipoprotein B (apo B) containing particles, but increases High-Density Lipoprotein Cholesterol (HDL-C). _In vitro_ and _in vivo_ animal studies also demonstrate that atorvastatin exerts vasculoprotective effects independent of its lipid-lowering properties, also known as the pleiotropic effects of statins. These effects include improvement in endothelial function, enhanced stability of atherosclerotic plaques, reduced oxidative stress and inflammation, and inhibition of the thrombogenic response. Statins were also found to bind allosterically to 2 integrin function-associated antigen-1 (LFA-1), which plays an essential role in leukocyte trafficking and T cell activation.

    In animal models, Lipitor lowers plasma cholesterol and lipoprotein levels by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase and cholesterol synthesis in the liver and by increasing the number of hepatic low-density lipoprotein (LDL) receptors on the cell surface to enhance uptake and catabolism of LDL; Lipitor also reduces LDL production and the number of LDL particles. Lipitor reduces LDL-cholesterol (LDL-C) in some patients with homozygous familial hypercholesterolemia (FH), a population that rarely responds to other lipid-lowering medication(s).

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    Lipitor is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. With ultracentrifugation, these complexes separate into HDL (high-density lipoprotein), IDL (intermediate-density lipoprotein), LDL (low-density lipoprotein), and VLDL (very-low-density lipoprotein) fractions. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. LDL is formed from VLDL and is catabolized primarily through the high-affinity LDL receptor. Clinical and pathologic studies show that elevated plasma levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), and apolipoprotein B (apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of HDL-C are associated with a decreased cardiovascular risk.

    NIH; DailyMed. Current Medication Information for Lipitor (Atorvastatin Calcium) Tablet, Film-coated (Updated: November 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228

    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 atorvastatin/ 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. ...

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

    3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) exert potent vasculoprotective effects. However, the potential contribution to angiogenesis is controversial. In the present study, we demonstrate that atorvastatin dose-dependently affects endothelial cell migration and angiogenesis. In vivo relevant concentrations of 0.01 to 0.1 umol/L atorvastatin or mevastatin promote the migration of mature endothelial cells and tube formation. Moreover, atorvastatin also increases migration and the potency to form vessel structures of circulating endothelial progenitor cells, which may contribute to vasculogenesis. In contrast, higher concentrations (>0.1 umol/L atorvastatin) block angiogenesis and migration by inducing endothelial cell apoptosis. The dose-dependent promigratory and proangiogenic effects of atorvastatin on mature endothelial cells are correlated with the activation of the phosphatidylinositol 3-kinase-Akt pathway, as determined by the phosphorylation of Akt and endothelial NO synthase (eNOS) at Ser1177. In addition, the stimulation of migration and tube formation was blocked by phosphatidylinositol 3-kinase inhibitors. In contrast, the well-established stabilization of eNOS mRNA was achieved only at higher concentrations, suggesting that posttranscriptional activation rather than an increase in eNOS expression mediates the proangiogenic effect of atorvastatin. Taken together, these data suggest that statins exert a double-edged role in angiogenesis signaling by promoting the migration of mature endothelial cells and endothelial progenitor cells at low concentrations, whereas the antiangiogenic effects were achieved only at high concentrations.

    PMID:11934843 Urbich C et al; Circ Res 90 (6): 737-44 (2002)

    Here, we found that atorvastatin promoted the expansion of myeloid-derived suppressor cells (MDSCs) both in vitro and in vivo. Atorvastatin-derived MDSCs suppressed T-cell responses by nitric oxide production. Addition of mevalonate, a downstream metabolite of 3-hydroxy-3-methylglutaryl coenzyme A reductase, almost completely abrogated the effect of atorvastatin on MDSCs, indicating that the mevalonate pathway was involved. Along with the amelioration of dextran sodium sulfate (DSS) -induced murine acute and chronic colitis, we observed a higher MDSC level both in spleen and intestine tissue compared with that from DSS control mice. More importantly, transfer of atorvastatin-derived MDSCs attenuated DSS acute colitis and T-cell transfer of chronic colitis. Hence, our data suggest that the expansion of MDSCs induced by statins may exert a beneficial effect on autoimmune diseases. In summary, our study provides a novel potential mechanism for statins-based treatment in inflammatory bowel disease and perhaps other autoimmune diseases.

    PMID:27548304 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5095490 Lei A et al; Immunology 149 (4): 432-446 (2016)

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    08

    Dr Reddys Laboratories Ltd

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25902

    Submission : 2012-03-23

    Status : Active

    Type : II

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    Lek Pharmaceuticals Dd

    Slovenia

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    Not Confirmed

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    Lek Pharmaceuticals Dd

    Slovenia
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18082

    Submission : 2005-02-01

    Status : Active

    Type : II

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    Bioprocess International Europe
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    Ranbaxy Laboratories Ltd

    India
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    Bioprocess International Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17484

    Submission : 2004-06-21

    Status : Inactive

    Type : II

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    Listed Suppliers

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    Mankind Pharma

    India
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    Bioprocess International Europe
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    Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

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    About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...

    Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic categories, including antibiotics, antifungals, NSAIDs, gastrointestinal, anthelmintic, cardiovascular, dermal, and erectile dysfunction products. Supported by a nationwide distribution network of C&F agents and stockists, Mankind Pharma serves markets across India with a strong focus on scale, accessibility, and product reach. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Dr. Reddy's Laboratories

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Atorvastatin

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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    03

    Jai Radhe Sales

    India
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Atorvastatin

    About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

    Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    04

    LGM Pharma

    U.S.A
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    Booth #730
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Atorvastatin

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    05

    Metrochem API Private Limited

    India
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Atorvastatin

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    06

    Rochem International Inc

    U.S.A
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Atorvastatin

    About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...

    Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered in Hauppauge, New York, it operates 16 offices worldwide. Rochem’s operations are fully cGMP compliant and have been audited by the USFDA and several multinational organizations. The company also trains and audits its partners to ensure FDA-compliant technologies and systems. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Rochem

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    07

    Temad Co

    Iran
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    Virtual BoothTemad- We think of world-class quality.

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    Atorvastatin

    About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...

    Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Iranian GMP and international standards like ISO 9001/14001/17025/45001 and OHSAS 18001. Temad manufactures over 115 pharmaceutical products, meeting GMP and WHO standards, and exports to 45 countries worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Temad

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    08

    Emay Pharmaceuticals

    India
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    Virtual BoothEmay Pharmaceuticals is a GMP-certified API manufacturing company.

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    Atorvastatin Calcium

    About the Company : Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of...

    Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of experience in manufacturing and exporting pharmaceutical and allied products. Supported by a team of experienced professionals, Emay Pharmaceuticals specializes in Human Health and Veterinary Health APIs, as well as the trade of raw materials for pharmaceutical applications, with a strong focus on quality and reliability. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Emay Pharmaceuticals

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    09

    HRV Pharma

    India
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    Not Confirmed
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    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    Atorvastatin

    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    HRV Global Life Sciences

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    10

    Octavius Pharma Pvt. Ltd

    India
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    Not Confirmed
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Atorvastatin

    About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...

    Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfolio includes DC granules, herbal and food supplements, APIs, and finished formulations such as tablets, capsules, syrups, and ointments. With WHO-GMP certification and a DSIR-certified R&D center, the company ensures quality and innovation, exporting to LATAM, the Middle East, Africa, Asia, and CIS regions, and offering formulation and marketing support. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Octavius Pharma

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

    USFDA APPLICATION NUMBER - 200153

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    DOSAGE - TABLET;ORAL - EQ 20MG BASE;10MG **Fe...DOSAGE - TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - TABLET;ORAL - EQ 40MG BASE;10MG **Fe...DOSAGE - TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - TABLET;ORAL - EQ 80MG BASE;10MG **Fe...DOSAGE - TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    USFDA APPLICATION NUMBER - 20702

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 10MG B...DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

    USFDA APPLICATION NUMBER - 21540

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    USFDA APPLICATION NUMBER - 21540

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    USFDA APPLICATION NUMBER - 21540

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    DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG ...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

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    DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG ...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

    USFDA APPLICATION NUMBER - 21540

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 10MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

    USFDA APPLICATION NUMBER - 21540

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

    USFDA APPLICATION NUMBER - 21540

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

    USFDA APPLICATION NUMBER - 21540

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BA...DOSAGE - TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

    USFDA APPLICATION NUMBER - 21540

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    ABOUT THIS PAGE

    Looking for 134523-00-5 / Atorvastatin API manufacturers, exporters & distributors?

    Atorvastatin manufacturers, exporters & distributors 1

    21

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

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

    API | Excipient name

    Atorvastatin

    Synonyms

    134523-00-5, Cardyl, Lipitor, 110862-48-1, Torvast, Atorvastatin calcium

    Cas Number

    134523-00-5

    Unique Ingredient Identifier (UNII)

    A0JWA85V8F

    About Atorvastatin

    A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

    Xarator Manufacturers

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

    Xarator Suppliers

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

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

    Xarator USDMF

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

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

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

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

    Xarator KDMF

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

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

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

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

    Xarator CEP

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

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

    Xarator WC

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

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

    Xarator 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 Xarator as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Xarator GMP

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

    Xarator CoA

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

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

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