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    Chemistry

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    Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect
    Molecular Formula
    C23H35NaO7
    Molecular Weight
    446.5  g/mol
    InChI Key
    VWBQYTRBTXKKOG-IYNICTALSA-M
    FDA UNII
    3M8608UQ61
    Pravastatin
    An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).
    1 2D Structure

    Pravastatin

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

    1. Apo Pravastatin

    2. Apo-pravastatin

    3. Bristacol

    4. Cs 514

    5. Cs-514

    6. Cs514

    7. Elisor

    8. Eptastatin

    9. Lin Pravastatin

    10. Lin-pravastatin

    11. Lipemol

    12. Liplat

    13. Lipostat

    14. Mevalotin

    15. Nu Pravastatin

    16. Nu-pravastatin

    17. Prareduct

    18. Pravachol

    19. Pravacol

    20. Pravasin

    21. Pravastatin

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

    23. Pravastatin Sodium Salt

    24. Pravastatin Tert Octylamine Salt

    25. Pravastatin Tert-octylamine Salt

    26. Pravastatin, (6 Beta)-isomer

    27. Rms 431

    28. Rms-431

    29. Rms431

    30. Selektine

    31. Sodium Salt, Pravastatin

    32. Sq 31,000

    33. Sq 31000

    34. Sq-31,000

    35. Sq-31000

    36. Sq31,000

    37. Sq31000

    38. Vasten

    2.3.2 Depositor-Supplied Synonyms

    1. 81131-70-6

    2. Pravachol

    3. Mevalotin

    4. Selektine

    5. Elisor

    6. Pravaselect

    7. Lipostat

    8. Eptastatin Sodium

    9. Cs-514

    10. Pravastatin Sodium Salt

    11. Pravastatin (sodium)

    12. Dehypotin Protect

    13. Sq-31000

    14. Sq-31,000

    15. Chebi:8361

    16. Bristacol

    17. Lipemol

    18. Prareduct

    19. Pravacol

    20. Pravasin

    21. 3m8608uq61

    22. Nsc-759253

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

    24. Aplactin

    25. Lipidal

    26. Liprevil

    27. Pralidon

    28. Pravasine

    29. Sanaprav

    30. Selipran

    31. Vasen

    32. Epastatin Sodium

    33. Dsstox_cid_27525

    34. Dsstox_rid_82395

    35. Dsstox_gsid_47525

    36. Liplat

    37. Vasten

    38. Pravastatin, Sodium Salt

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

    40. Cas-81131-70-6

    41. Pravastatin Natrium Mayrho Fer

    42. Sq 31000

    43. 3-beta-hydroxycompactin Sodium Salt

    44. Drg-0319

    45. Chembl690

    46. Unii-3m8608uq61

    47. Cres Pravastatin

    48. Pravachol (tn)

    49. Ncgc00095183-01

    50. Pravastatin Sodium [usan:usp:jan]

    51. Mfcd00887601

    52. Pravastatinsodium,(s)

    53. Cs-514 Sodium

    54. Pravastatin Sodium- Bio-x

    55. Schembl3013

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

    57. Pravastatin Sodium [mi]

    58. Dtxsid6047525

    59. Pravastatin Sodium [jan]

    60. Hy-b0165a

    61. Pravastatin Sodium (jp17/usp)

    62. Pravastatin Sodium [usan]

    63. Hms2051p05

    64. Hms3268l20

    65. Hms3413e20

    66. Pravastatin Sodium [vandf]

    67. Hexahydronaphthalen-1-yl)heptanoate

    68. Pravastatin Sodium [mart.]

    69. Amy40517

    70. Pravastatin Sodium [usp-rs]

    71. Pravastatin Sodium [who-dd]

    72. Tox21_111474

    73. Tox21_300270

    74. S3036

    75. Akos015896504

    76. Akos015964902

    77. Ccg-100926

    78. Cs-2003

    79. Nc00176

    80. Nsc 759253

    81. Pravastatin Sodium [orange Book]

    82. Ncgc00092370-01

    83. Ncgc00254232-01

    84. Pravastatin Sodium [ep Monograph]

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

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

    87. Bp164292

    88. Pravastatin Sodium [usp Monograph]

    89. P1796

    90. D00893

    91. Pravigard Pac Component Pravastatin Sodium

    92. Pravastatin Sodium Component Of Pravigard Pac

    93. Q27108059

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

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

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

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

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

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

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

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

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

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

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

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

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

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anticholesteremic Agents

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

    Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

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

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    NDC Package Code : 58623-0123

    Start Marketing Date : 2018-05-04

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2022-06-07

    Registration Number : 20220607-70-B-464-09

    Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.

    Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China

     VMF Others AUDIT arrow-down
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    09

    Zhejiang Hisun Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ICMD China
    Not Confirmed
    arrow

    Zhejiang Hisun Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ICMD China
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18709

    Submission : 2005-08-24

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    10

    Sun Pharmaceutical Industries Limi...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ICMD China
    Not Confirmed
    arrow

    Sun Pharmaceutical Industries Limi...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ICMD China
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16031

    Submission : 2002-06-26

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2003-230 - Rev 00

    Issue Date : 2009-12-14

    Type : Chemical

    Substance Number : 2059

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Drugs in Development

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

    Details:

    Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.


    Lead Product(s): Alirocumab,Atorvastatin,Simvastatin,Fluvastatin,Pravastatin,Lovastatin,Rosuvastatin Calcium,Ezetimibe,

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 27, 2018

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    01

    Sanofi

    France
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    ICMD China
    Not Confirmed
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Alirocumab, Atorvastatin, Simvastatin, Fluvastatin, Pravastatin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hy...

    Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    April 27, 2018

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

    Details:

    Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.


    Lead Product(s): Alirocumab,Rosuvastatin Calcium,Atorvastatin,Simvastatin,Pravastatin,Lovastatin,Fluvastatin,Ezetimibe,

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 27, 2018

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    02

    Sanofi

    France
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    ICMD China
    Not Confirmed
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Alirocumab, Rosuvastatin Calcium, Atorvastatin, Simvastatin, Pravastatin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial ...

    Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    April 27, 2018

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    • Development Update
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hyper...

    Details:

    Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.


    Lead Product(s): Alirocumab,Pravastatin,Simvastatin,Fluvastatin,Atorvastatin,Pitavastatin,Rosuvastatin Calcium

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 08, 2014

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    03

    Sanofi

    France
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    Not Confirmed
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Alirocumab, Pravastatin, Simvastatin, Fluvastatin, Atorvastatin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholester...

    Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    April 08, 2014

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

    Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions

    Details:

    Pravastatin Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Pravastatin,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 17, 2010

    Dr Reddy Company Banner

    04

    Dr. Reddy's Laboratories

    India
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    Lead Product(s) : Pravastatin,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions

    Details : Pravastatin Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 17, 2010

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    Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

    Details:

    Pravastatin Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Pravastatin,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 17, 2010

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    05

    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.

    Lead Product(s) : Pravastatin,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

    Details : Pravastatin Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 17, 2010

    Dr Reddy Company Banner

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Sunshine Biopharma Launches Cholesterol-Fighting Pravastatin Medicine

    Details:

    Pravastatin Sodium, a miscellaneous product targeting HMG-CoA reductase, shows promise in treating high cholesterol.


    Lead Product(s): Pravastatin

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Pravachol-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Sunshine Biopharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 16, 2025

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    06

    Nora Pharma

    Canada
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    ICMD China
    Not Confirmed

    Nora Pharma

    Canada
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    ICMD China
    Not Confirmed
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    Lead Product(s) : Pravastatin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sunshine Biopharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sunshine Biopharma Launches Cholesterol-Fighting Pravastatin Medicine

    Details : Pravastatin Sodium, a miscellaneous product targeting HMG-CoA reductase, shows promise in treating high cholesterol.

    Product Name : Pravachol-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 16, 2025

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    A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

    Details:

    BMS-986196 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): BMS-986196,Caffeine,Montelukast Sodium,Flurbiprofen,Omeprazole,Midazolam,Digoxin,Pravastatin

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 10, 2023

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    07

    Bristol Myers Squibb

    U.S.A
    arrow
    ICMD China
    Not Confirmed

    Bristol Myers Squibb

    U.S.A
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    ICMD China
    Not Confirmed
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    Lead Product(s) : Caffeine, Montelukast Sodium, Flurbiprofen, Omeprazole, Midazolam

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

    Details : BMS-986196 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 10, 2023

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    Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drug...

    Details:

    Atorvastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Rheumatoid.


    Lead Product(s): Atorvastatin,Pravastatin,Rosuvastatin Calcium,Filgotinib

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Galapagos

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 29, 2020

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    08

    Gilead Sciences

    U.S.A
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    ICMD China
    Not Confirmed

    Gilead Sciences

    U.S.A
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    Lead Product(s) : Atorvastatin,Pravastatin,Rosuvastatin Calcium,Filgotinib

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Galapagos

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Int...

    Details : Atorvastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Rheumatoid.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 29, 2020

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    Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pr...

    Details:

    GSK3640254 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of HIV Infections.


    Lead Product(s): GSK3640254,Caffeine,Metoprolol Tartrate,Montelukast Sodium,Flurbiprofen,Omeprazole,Midazolam,Digoxin,Pravastatin

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 11, 2020

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    09

    ViiV Healthcare

    United Kingdom
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    ICMD China
    Not Confirmed

    ViiV Healthcare

    United Kingdom
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    ICMD China
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    Lead Product(s) : Caffeine, Metoprolol Tartrate, Montelukast Sodium, Flurbiprofen, Omeprazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast...

    Details : GSK3640254 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of HIV Infections.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 11, 2020

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    Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

    Details:

    Vadadustat is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Vadadustat,Rosuvastatin Calcium,Pravastatin,Sulfasalazine,Simvastatin,Atorvastatin

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 11, 2019

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    Akebia Therapeutics

    U.S.A
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    ICMD China
    Not Confirmed

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    Lead Product(s) : Vadadustat, Rosuvastatin Calcium, Pravastatin, Sulfasalazine, Simvastatin

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvasta...

    Details : Vadadustat is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 11, 2019

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

    USFDA APPLICATION NUMBER - 19898

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

    USFDA APPLICATION NUMBER - 19898

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

    USFDA APPLICATION NUMBER - 19898

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

    USFDA APPLICATION NUMBER - 19898

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    india-flag.png
    EP Grade Pravastatin Sodium (10) API needed in India [ENA17035]
    A company that focuses on the manufacturing of finished formulations is looking for suppliers of EP Grade Pravastatin Sodium (10) API for development purposes. The suppliers must support this enquiry with CoA.
    04 May 2023

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    04 May 2023

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    04 May 2023

    France.png
    Various APIs needed in France [ENA14579]
    European CDMO specialized in the contract development and manufacturing of pharmaceutical products for humans, animals and medical devices is looking for suppliers of Various APIs for commercial purposes. The suppliers must support this enquiry with CEP/ DMF, GMP & CoA. 1. Pravastatin (750 kg) API 2. Mesoglycan (600 kg) API 3. Fenofibrate (3 MT) API
    04 Aug 2022

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    04 Aug 2022

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    04 Aug 2022

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    EP Grade Pentoxifylline & Pravastatin Sodium APIs needed in India [ENA13162]
    A company that specializes in the R&D and manufacturing of oral solid dosage forms is looking for suppliers of EP Grade Pentoxifylline & Pravastatin Sodium APIs for development purpose. The required quantity is MOQ for each. The suppliers must support this enquiry with CEP & CoA.
    30 Mar 2022

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    30 Mar 2022

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    30 Mar 2022

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    Ph. Eur/BP Grade Pravastatin API needed in India [ENA07512]
    Paavak Corporation, A pharmaceutical trading company is looking for suppliers of Ph. Eur/BP Grade Pravastatin API. The required quantity is 100 kg per every 3 months. The suppliers must support this enquiry with DMF. Interested suppliers can contact them via their email: paavak.corporation@gmail.com.
    08 Jun 2020

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    08 Jun 2020

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    08 Jun 2020

    Mexico.png
    Magnesium Hydroxide, Aluminum Hydroxide and other products needed in Mexico [ENA02542]
    Antvol Chemicals de Mexico is looking for suppliers of following products: 1. Magnesium Hydroxide (25 tons) 2.Aluminum Hydroxide (30 tons) 3. Ambroxol (5 tons) 4. Amoxicillin Trihydrate Compact (30 tons) 5. Amoxicillin Trihydrate Powder (10 tons) 6. Ampicillin Trihydrate Compact (35 tons) 7. Captopril (3 tons) 8. Cinitapride Tartrate (33 KG) 9. Ciprofloxacin HCL (21 tons) 10. Clopidogrel Bisulfate (2.5 tons) 11. Pravastatin Sodium (2.1 tons) 12. Fluoxetine HCL (1 TON) 13. Metamizole Sodium (17 tons) 14. Metformin HCL Granular DC (578 tons) 15. Paracetamol Powder (7.8 tons) 16. Omeprazole Pellets (10 tons) 17. Ranitidine (10 tons) 18. Pravastatin Sodium (2.1 tons) 19. Diclofenac Sodium (24 tons) 20. Metoprolol Tartrate (21 tons) Interested suppliers can contact Raul Paramo via Email: rpgodinez@antvol.com or Tel: +5213336821212.
    03 Nov 2018

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    03 Nov 2018

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    03 Nov 2018

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    Enquiry// Pravastatin Sodium API (1000kg) needed in India [ENA01704]
    SGMR Pvt. Ltd is a renowned manufacturer of APIs and Intermediates headquartered in Hyderabad, India. The company is looking for the suppliers of Pravastatin Sodium API (1000kg). Interested suppliers must contact Surareddy Jaggavarapu via E-mail: surareddyj@gmail.com or Tel: 8897454742.
    30 Aug 2018

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    30 Aug 2018

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    30 Aug 2018

    Market Place
    Enquiry// Valsartan, Hydrochlorothiazide, Zolpidem Tartrate and other APIs are needed in India [ENA01374]
    Celogen generics brings to global market Quality Generics, which are equivalent to the original molecule. Celogen is looking for suppliers of the following APIs: 1) Valsartan- 2800kg 2) Hydrochlorothiazide- 100 3) Zolpidem Tartrate- 50kg 4) Telmisartan- 250kg 5) Orlistat- 1300kg 6) Pravastatin Sodium- 1100kg 7) Ramipril- 1700 8) Olmesartan Medoxomil- 110kg 9) Lisinopril Dihydrate- 55kg 10) Gliclazide – 10150kg 11) Donepezil Hydrochloride- 125kg 12) Cinacalet Hydrochloride- 100kg 13) Dihydrocodeine Tartrate- 700kg 14) Paracetamol- 35200kg 15) Captopril- 25kg 16) Cimetidine- 800kg Interested suppliers must support this enquiry with CEP.
    07 Aug 2018

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    07 Aug 2018

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    07 Aug 2018

    Market Place
    Enquiry// CEP grade Pravastatin API needed in India [ENA01330]
    A company engaged in the manufacturing and marketing of Formulation (Finished Dosage Forms) in India, is looking for suppliers of CEP grade Pravastatin API for domestic consumption. The annual requirement is 1078 kg which will be bought in 6 lots of approx. 175 kg each.
    03 Aug 2018

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    03 Aug 2018

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    03 Aug 2018

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

    Pravastatin manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Pravastatin

    Synonyms

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

    Cas Number

    81131-70-6

    Unique Ingredient Identifier (UNII)

    3M8608UQ61

    About Pravastatin

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

    PRAVIGARD PAC (COPACKAGED)-1 Manufacturers

    A PRAVIGARD PAC (COPACKAGED)-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PRAVIGARD PAC (COPACKAGED)-1, including repackagers and relabelers. The FDA regulates PRAVIGARD PAC (COPACKAGED)-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 Suppliers

    A PRAVIGARD PAC (COPACKAGED)-1 supplier is an individual or a company that provides PRAVIGARD PAC (COPACKAGED)-1 active pharmaceutical ingredient (API) or PRAVIGARD PAC (COPACKAGED)-1 finished formulations upon request. The PRAVIGARD PAC (COPACKAGED)-1 suppliers may include PRAVIGARD PAC (COPACKAGED)-1 API manufacturers, exporters, distributors and traders.

    click here to find a list of PRAVIGARD PAC (COPACKAGED)-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 USDMF

    A PRAVIGARD PAC (COPACKAGED)-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of PRAVIGARD PAC (COPACKAGED)-1 active pharmaceutical ingredient (API) in detail. Different forms of PRAVIGARD PAC (COPACKAGED)-1 DMFs exist exist since differing nations have different regulations, such as PRAVIGARD PAC (COPACKAGED)-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A PRAVIGARD PAC (COPACKAGED)-1 DMF submitted to regulatory agencies in the US is known as a USDMF. PRAVIGARD PAC (COPACKAGED)-1 USDMF includes data on PRAVIGARD PAC (COPACKAGED)-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PRAVIGARD PAC (COPACKAGED)-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of PRAVIGARD PAC (COPACKAGED)-1 suppliers with USDMF on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 Drug Master File in Japan (PRAVIGARD PAC (COPACKAGED)-1 JDMF) empowers PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 JDMF during the approval evaluation for pharmaceutical products. At the time of PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 suppliers with JDMF on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 KDMF

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

    Pharmaceutical companies submit a PRAVIGARD PAC (COPACKAGED)-1 Drug Master File in Korea (PRAVIGARD PAC (COPACKAGED)-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PRAVIGARD PAC (COPACKAGED)-1. The MFDS reviews the PRAVIGARD PAC (COPACKAGED)-1 KDMF as part of the drug registration process and uses the information provided in the PRAVIGARD PAC (COPACKAGED)-1 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of PRAVIGARD PAC (COPACKAGED)-1 suppliers with KDMF on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 CEP

    A PRAVIGARD PAC (COPACKAGED)-1 CEP of the European Pharmacopoeia monograph is often referred to as a PRAVIGARD PAC (COPACKAGED)-1 Certificate of Suitability (COS). The purpose of a PRAVIGARD PAC (COPACKAGED)-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PRAVIGARD PAC (COPACKAGED)-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PRAVIGARD PAC (COPACKAGED)-1 to their clients by showing that a PRAVIGARD PAC (COPACKAGED)-1 CEP has been issued for it. The manufacturer submits a PRAVIGARD PAC (COPACKAGED)-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PRAVIGARD PAC (COPACKAGED)-1 CEP holder for the record. Additionally, the data presented in the PRAVIGARD PAC (COPACKAGED)-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PRAVIGARD PAC (COPACKAGED)-1 DMF.

    A PRAVIGARD PAC (COPACKAGED)-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 suppliers with CEP (COS) on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 WC

    A PRAVIGARD PAC (COPACKAGED)-1 written confirmation (PRAVIGARD PAC (COPACKAGED)-1 WC) is an official document issued by a regulatory agency to a PRAVIGARD PAC (COPACKAGED)-1 manufacturer, verifying that the manufacturing facility of a PRAVIGARD PAC (COPACKAGED)-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PRAVIGARD PAC (COPACKAGED)-1 APIs or PRAVIGARD PAC (COPACKAGED)-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a PRAVIGARD PAC (COPACKAGED)-1 WC (written confirmation) as part of the regulatory process.

    click here to find a list of PRAVIGARD PAC (COPACKAGED)-1 suppliers with Written Confirmation (WC) on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PRAVIGARD PAC (COPACKAGED)-1 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of PRAVIGARD PAC (COPACKAGED)-1 suppliers with NDC on PharmaCompass.

    PRAVIGARD PAC (COPACKAGED)-1 GMP

    PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 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 PRAVIGARD PAC (COPACKAGED)-1 GMP manufacturer or PRAVIGARD PAC (COPACKAGED)-1 GMP API supplier for your needs.

    PRAVIGARD PAC (COPACKAGED)-1 CoA

    A PRAVIGARD PAC (COPACKAGED)-1 CoA (Certificate of Analysis) is a formal document that attests to PRAVIGARD PAC (COPACKAGED)-1's compliance with PRAVIGARD PAC (COPACKAGED)-1 specifications and serves as a tool for batch-level quality control.

    PRAVIGARD PAC (COPACKAGED)-1 CoA mostly includes findings from lab analyses of a specific batch. For each PRAVIGARD PAC (COPACKAGED)-1 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.

    PRAVIGARD PAC (COPACKAGED)-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (PRAVIGARD PAC (COPACKAGED)-1 EP), PRAVIGARD PAC (COPACKAGED)-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PRAVIGARD PAC (COPACKAGED)-1 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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