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    Chemistry

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    Also known as: 82640-04-8, Raloxifene hcl, Evista, Keoxifene hydrochloride, Keoxifene, Optruma
    Molecular Formula
    C28H28ClNO4S
    Molecular Weight
    510.0  g/mol
    InChI Key
    BKXVVCILCIUCLG-UHFFFAOYSA-N
    FDA UNII
    4F86W47BR6
    Raloxifene Hydrochloride
    A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.
    1 2D Structure

    Raloxifene Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone;hydrochloride
    2.1.2 InChI
    InChI=1S/C28H27NO4S.ClH/c30-21-8-4-20(5-9-21)28-26(24-13-10-22(31)18-25(24)34-28)27(32)19-6-11-23(12-7-19)33-17-16-29-14-2-1-3-15-29;/h4-13,18,30-31H,1-3,14-17H2;1H
    2.1.3 InChI Key
    BKXVVCILCIUCLG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CCN(CC1)CCOC2=CC=C(C=C2)C(=O)C3=C(SC4=C3C=CC(=C4)O)C5=CC=C(C=C5)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    4F86W47BR6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Evista

    2. Keoxifene

    3. Keoxifene Hydrochloride

    4. Ly 139481

    5. Ly 156758

    6. Ly-139481

    7. Ly-156758

    8. Ly139481

    9. Ly156758

    10. Raloxifene

    11. Raloxifene Hcl

    2.3.2 Depositor-Supplied Synonyms

    1. 82640-04-8

    2. Raloxifene Hcl

    3. Evista

    4. Keoxifene Hydrochloride

    5. Keoxifene

    6. Optruma

    7. Raloxifene Teva

    8. (6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl)(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone Hydrochloride

    9. Raloxifene (hydrochloride)

    10. Ly 156758

    11. Ly156758

    12. Ly-156758

    13. Nsc-706725

    14. 2-(4-hydroxyphenyl)-3-({4-[2-(piperidin-1-yl)ethoxy]phenyl}carbonyl)-1-benzothiophen-6-ol Hydrochloride

    15. Chebi:50740

    16. Evista (raloxifene Hydrochloride)

    17. 4f86w47br6

    18. 6-hydroxy-2-(p-hydroxyphenyl)benzo(b)thien-3-yl-p-(2-piperidinoethoxy)phenyl Ketone, Hydrochloride

    19. Dsstox_cid_14181

    20. Dsstox_rid_79119

    21. Dsstox_gsid_34181

    22. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

    23. [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone;hydrochloride

    24. Smr000058508

    25. Raloxifene Hydrochloride [usan]

    26. Ncgc00015889-05

    27. Cas-82640-04-8

    28. C28h27no4s.hcl

    29. Loxifen

    30. Unii-4f86w47br6

    31. Sr-01000076102

    32. Cdt-raloxifene

    33. Raloxifene-d4 Hcl

    34. Raloxifene Cloridrato

    35. Evista (tn)

    36. Mfcd01938233

    37. Prestwick_1035

    38. Raloxifene Hydrochloride [usan:usp]

    39. Methanone, Hydrochloride

    40. Cloridrato De Raloxifeno

    41. Clorhidrato De Raloxifeno

    42. Chlorhydrate De Raloxifene

    43. Ly139481 Hydrochloride

    44. Ly156758 Hydrochloride

    45. Chembl1116

    46. Schembl19077

    47. Mls000859902

    48. Mls001332533

    49. Mls001332534

    50. Mls002222293

    51. Raloxifene Hydrochloride, Solid

    52. Evista, Raloxifene Hydrochloride

    53. Raloxifene Hydrochloride- Bio-x

    54. Dtxsid1034181

    55. Ly156758 (keoxifene) Hcl

    56. Ly-139481 Hcl

    57. Hms1570n05

    58. Pharmakon1600-01505622

    59. Amy23426

    60. Bcp05713

    61. Raloxifene Hydrochloride (jan/usp)

    62. Tox21_110255

    63. Tox21_302369

    64. Tox21_501051

    65. Hy-13738a

    66. Nsc706725

    67. Nsc759285

    68. Raloxifene Hydrochloride [mi]

    69. S1227

    70. Raloxifene Hydrochloride [jan]

    71. Akos008131940

    72. Tox21_110255_1

    73. Ac-8390

    74. Ccg-213497

    75. Cs-1775

    76. Ds-2162

    77. Ks-1102

    78. Lp01051

    79. Nc00665

    80. Nsc 706725

    81. Nsc 759285

    82. Nsc-759285

    83. Raloxifene Hydrochloride [mart.]

    84. Raloxifene Hydrochloride [vandf]

    85. Ncgc00015889-03

    86. Ncgc00015889-11

    87. Ncgc00092353-01

    88. Ncgc00092353-03

    89. Ncgc00094334-01

    90. Ncgc00094334-02

    91. Ncgc00255153-01

    92. Ncgc00261736-01

    93. Raloxifene Hydrochloride [usp-rs]

    94. Raloxifene Hydrochloride [who-dd]

    95. Br164310

    96. Methanone, (6-hydroxy-2-(4-hydroxyphenyl)benzo(b)thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)-, Hydrochloride

    97. Methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-,hydrochloride (1:1)

    98. Raloxifene Hydrochloride [ema Epar]

    99. Eu-0101051

    100. Ft-0630912

    101. R0109

    102. Sw197106-5

    103. En300-52517

    104. Raloxifene Hydrochloride [orange Book]

    105. D02217

    106. R 1402

    107. Raloxifene Hydrochloride [ep Monograph]

    108. Raloxifene Hydrochloride [usp Impurity]

    109. Raloxifene Hydrochloride [usp Monograph]

    110. 640r048

    111. A840401

    112. Q-201656

    113. Sr-01000076102-2

    114. Sr-01000076102-9

    115. Q27122215

    116. (6-oxo-1,6-dihydro-pyridazin-3-yloxy)-aceticacid

    117. Raloxifene Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    118. Raloxifene Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    119. Raloxifene Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    120. (6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl)-(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone Hydrochloride

    121. (6-oh-2-(4-oh-ph)benzo[b]thiophen-3-yl)(4-(2-(piperidin-1-yl)ethoxy)ph)methanone Hydrochloride

    122. [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothien-3-yl][4-(2-piperidin-1-ylethoxy)phenyl]methanone Hydrochloride

    123. [6-hydroxy-2-(4-hydroxyphenyl)-benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

    124. [6-hydroxy-2-(4-hydroxyphenyl)benzo [b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

    125. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

    126. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone, Monohydrochloride

    127. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

    128. [6-hydroxy-2[4-hydroxyphenyl)benzo [b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

    129. [6-hydroxy-2[4-hydroxyphenyl)benzo [b]thien3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

    130. [6-hydroxy-2[4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

    131. 1-[2-(4-{[6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]carbonyl}phenoxy)ethyl]piperidinium Chloride

    132. 6-hydroxy-2-(4-hydroxyphenyl)-3-[ 4-(2-piperidinoethoxy)benzoyl]benzo[b]thiophene, Hydrochloride

    133. 6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]-benzo[b]-thiophene Hydrochloride

    134. 6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]-benzo[b]thiophene Hydrochloride

    135. 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl 4-[2-(1-piperidinyl)ethoxy]phenyl Methanone Hydrochloride

    136. 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl 4-[2-(1-piperidinyl)ethoxy]phenyl Ketone Hydrochloride

    137. 6-hydroxy-2-(p-hydroxyphenyl)benzo(.beta.)thien-3-yl-p-(2-piperidinoethoxy)phenyl Ketone, Hydrochloride

    138. Methanone, (6-hydroxy-2-(4-hydroxyphenyl)benzo(.beta.)thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)-, Hydrochloride

    139. Methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-, Hydrochloride (1:1)

    140. Raloxifene Hydrochloride For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 510.0 g/mol
    Molecular Formula C28H28ClNO4S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count7
    Exact Mass509.1427572 g/mol
    Monoisotopic Mass509.1427572 g/mol
    Topological Polar Surface Area98.2 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity655
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameEvista
    PubMed HealthRaloxifene (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelEVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
    Active IngredientRaloxifene hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength60mg
    Market StatusPrescription
    CompanyLilly

    2 of 4  
    Drug NameRaloxifene hydrochloride
    Drug LabelEVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
    Active IngredientRaloxifene hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength60mg
    Market StatusTentative Approval; Prescription
    CompanyTeva Pharms Usa; Invagen Pharms; Watson Labs

    3 of 4  
    Drug NameEvista
    PubMed HealthRaloxifene (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelEVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
    Active IngredientRaloxifene hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength60mg
    Market StatusPrescription
    CompanyLilly

    4 of 4  
    Drug NameRaloxifene hydrochloride
    Drug LabelEVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
    Active IngredientRaloxifene hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength60mg
    Market StatusTentative Approval; Prescription
    CompanyTeva Pharms Usa; Invagen Pharms; Watson Labs

    4.2 Drug Indication

    Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5. 1).

    Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

    Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

    When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Selective Estrogen Receptor Modulators

    A structurally diverse group of compounds distinguished from ESTROGENS by their ability to bind and activate ESTROGEN RECEPTORS but act as either an agonist or antagonist depending on the tissue type and hormonal milieu. They are classified as either first generation because they demonstrate estrogen agonist properties in the ENDOMETRIUM or second generation based on their patterns of tissue specificity. (Horm Res 1997;48:155-63) (See all compounds classified as Selective Estrogen Receptor Modulators.)

    Bone Density Conservation Agents

    Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

    Estrogen Antagonists

    Compounds which inhibit or antagonize the action or biosynthesis of estrogenic compounds. (See all compounds classified as Estrogen Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Selective Estrogen Receptor Modulators [MoA]; Estrogen Agonist/Antagonist [EPC]
    5.3 ATC Code

    G03XC01

    G03XC01

    G03XC01

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    Dr. Reddy's Laboratories

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    Issue Date : 2023-03-31

    Type : Chemical

    Substance Number : 2375

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    Registrant Name : Alvogen Korea Co., Ltd.

    Registration Date : 2020-09-17

    Registration Number : 20200917-209-J-745

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    Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 India

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    Cadila Pharmaceuticals

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    Type : Chemical

    Substance Number : 2375

    Status : Valid

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    Registration Number : 303MF10064

    Registrant's Address : Strada Rivoltana Km. 6/7 20053 Rodano (MI), Italy

    Initial Date of Registration : 2021-04-13

    Latest Date of Registration :

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    NDC Package Code : 17337-0071

    Start Marketing Date : 2019-08-27

    End Marketing Date : 2025-12-31

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    Raks Pharma

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-09-14

    Pay. Date : 2017-08-01

    DMF Number : 31952

    Submission : 2017-08-23

    Status : Active

    Type : II

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    Medilux Laboratories

    India

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    Medilux Laboratories

    India

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39175

    Submission : 2023-11-29

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2023-432 - Rev 00

    Issue Date : 2024-12-11

    Type : Chemical

    Substance Number : 2375

    Status : Valid

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    Aurore Life Sciences

    India

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    Aurore Life Sciences

    India

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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 36445

    Submission : 2021-10-23

    Status : Active

    Type : II

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    Certificate Number : CEP 2022-165 - Rev 00

    Issue Date : 2024-04-22

    Type : Chemical

    Substance Number : 2375

    Status : Valid

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    Date of Issue : 2022-09-19

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0119

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    Aarti Drugs

    India

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    Aarti Drugs

    India

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    DMF Review : N/A

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    DMF Number : 21650

    Submission : 2008-05-22

    Status : Active

    Type : II

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    Date of Issue : 2022-08-10

    Valid Till : 2025-08-05

    Written Confirmation Number : WC-0219

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    NDC Package Code : 62704-0115

    Start Marketing Date : 1998-01-01

    End Marketing Date : 2025-12-31

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    API Reference Price

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DE","customerCountry":"MEXICO","quantity":"199.39","actualQuantity":"199.39","unit":"KGS","unitRateFc":"1300","totalValueFC":"253599.9","currency":"USD","unitRateINR":110167.05832790011,"date":"22-Mar-2025","totalValueINR":"21966209.76","totalValueInUsd":"253599.9","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"9239663","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666377000,"product":"RALOXIFENE HYDROCHLORIDE (REJECTED SHIPMENT VIDE SB NO: 1382621 DATED 26.04.21)","address":"JUBILEE HEIGHTS PLOT NO 68 & 69,2N D FLOOR SY NOS 66 & 67 MADHAPUR","city":"HYDERABAD,TELANGANA","supplier":"SAWAI PHARMACEUTICAL CO","supplierCountry":"INDIA","foreign_port":"NA","customer":"AURORE LIFE SCIENCES","customerCountry":"INDIA","quantity":"2.40","actualQuantity":"2.4","unit":"KGS","unitRateFc":"1400","totalValueFC":"4149.7","currency":"USD","unitRateINR":"142273.4","date":"22-Oct-2022","totalValueINR":"341456.22","totalValueInUsd":"4149.7","indian_port":"HYDERABAD AIR","hs_no":"29329990","bill_no":"3012107","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"JUBILEE HEIGHTS PLOT NO 68 & 69,2N D FLOOR SY NOS 66 & 67 MADHAPUR"}]
    16-Jan-2021
    22-Mar-2025
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    ABOUT THIS PAGE

    Looking for 82640-04-8 / Raloxifene Hydrochloride API manufacturers, exporters & distributors?

    Raloxifene Hydrochloride manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Raloxifene Hydrochloride

    Synonyms

    82640-04-8, Raloxifene hcl, Evista, Keoxifene hydrochloride, Keoxifene, Optruma

    Cas Number

    82640-04-8

    Unique Ingredient Identifier (UNII)

    4F86W47BR6

    About Raloxifene Hydrochloride

    A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.

    Raloxifene Hydrochloride Manufacturers

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

    Raloxifene Hydrochloride Suppliers

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

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

    Raloxifene Hydrochloride USDMF

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

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

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

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

    Raloxifene Hydrochloride KDMF

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

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

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

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

    Raloxifene Hydrochloride CEP

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

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

    Raloxifene Hydrochloride WC

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

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

    Raloxifene Hydrochloride 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 Raloxifene Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Raloxifene Hydrochloride GMP

    Raloxifene Hydrochloride 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 Raloxifene Hydrochloride 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 Raloxifene Hydrochloride GMP manufacturer or Raloxifene Hydrochloride GMP API supplier for your needs.

    Raloxifene Hydrochloride CoA

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

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

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