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    Also known as: 79559-97-0, Sertraline hcl, Zoloft, Gladem, Lustral, Serad
    Molecular Formula
    C17H18Cl3N
    Molecular Weight
    342.7  g/mol
    InChI Key
    BLFQGGGGFNSJKA-XHXSRVRCSA-N
    FDA UNII
    UTI8907Y6X
    Sertraline Hydrochloride
    A selective serotonin uptake inhibitor that is used in the treatment of depression.
    1 2D Structure

    Sertraline Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C17H17Cl2N.ClH/c1-20-17-9-7-12(13-4-2-3-5-14(13)17)11-6-8-15(18)16(19)10-11;/h2-6,8,10,12,17,20H,7,9H2,1H3;1H/t12-,17-;/m0./s1
    2.1.3 InChI Key
    BLFQGGGGFNSJKA-XHXSRVRCSA-N
    2.1.4 Canonical SMILES
    CNC1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl.Cl
    2.1.5 Isomeric SMILES
    CN[C@H]1CC[C@H](C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    UTI8907Y6X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Altruline

    2. Apo Sertraline

    3. Apo-sertraline

    4. Aremis

    5. Besitran

    6. Gen Sertraline

    7. Gen-sertraline

    8. Gladem

    9. Hydrochloride, Sertraline

    10. Lustral

    11. Novo Sertraline

    12. Novo-sertraline

    13. Ratio Sertraline

    14. Ratio-sertraline

    15. Rhoxal Sertraline

    16. Rhoxal-sertraline

    17. Sealdin

    18. Sertraline

    19. Sertraline Hydrochloride (1s-cis)-isomer

    20. Zoloft

    2.3.2 Depositor-Supplied Synonyms

    1. 79559-97-0

    2. Sertraline Hcl

    3. Zoloft

    4. Gladem

    5. Lustral

    6. Serad

    7. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

    8. Rac-cis-sertraline Hydrochloride

    9. Sertraline.hcl

    10. Sertraline (hydrochloride)

    11. 79617-95-1

    12. Nsc-746308

    13. Nsc-758948

    14. (+)-sertraline Hydrochloride

    15. Sertraline (as Hydrochloride)

    16. Sertraline Hydrechloride

    17. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

    18. Chebi:9124

    19. Uti8907y6x

    20. Cp-51974-1

    21. (+/-)-sertraline Hydrochloride

    22. Cp 51,974-1

    23. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthylamine Hydrochloride

    24. Atruline

    25. Tresleen

    26. Cp-51,974-1

    27. Tatig

    28. Dsstox_cid_20243

    29. Dsstox_rid_79456

    30. Dsstox_gsid_40243

    31. 1-naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, Hydrochloride, (1s-cis)-

    32. Adjuvin

    33. Aremis

    34. Mls001401398

    35. Mfcd00895772

    36. (+)-cis-(1s,4s)-1-methylamino-4-(3,4-dichlorophenyl)tetralin Hydrochloride

    37. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-aminium Chloride

    38. (1s-cis)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

    39. Cis-n-methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenaminehydrochloride

    40. Cas-79559-97-0

    41. Sertraline Hydrochloride [usan]

    42. Ncgc00092386-03

    43. Smr000466298

    44. C17h17cl2n.hcl

    45. Unii-uti8907y6x

    46. Serlift

    47. Sertraline, Hcl

    48. Sertraline Hydrochloride [usan:usp]

    49. Zoloft (tn)

    50. (1s,4s)-1-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-4-(methylamino)naphthalene Hydrochloride

    51. Cpd000466298

    52. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride

    53. Sertraline Impurity G Hcl

    54. Chembl1709

    55. Schembl23230

    56. Mls000758929

    57. Spectrum1505262

    58. Sertraline Hydrochloride- Bio-x

    59. Dtxsid1040243

    60. Hy-b0176a

    61. Sertraline For System Suitability

    62. (1r,4s)-sertraline Hcl

    63. Sertraline For Peak Identification

    64. Cp-51974-1 Hcl

    65. Hms1922p09

    66. Pharmakon1600-01505262

    67. (1r,4s)-sertraline Hydrochloride

    68. (1rs,4sr)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

    69. Sertraline Hydrochloride (jan/usp)

    70. Tox21_111199

    71. Tox21_500870

    72. Ac-740

    73. Ccg-39575

    74. Nsc746308

    75. Nsc758948

    76. Sertraline Hydrochloride [mi]

    77. Sertraline Hydrochloride [jan]

    78. Akos005267232

    79. Akos015846322

    80. Tox21_111199_1

    81. Cs-2052

    82. Ks-1111

    83. Lp00870

    84. Nc00198

    85. Nc00726

    86. Nsc 746308

    87. Nsc 758948

    88. (1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

    89. Sertraline Hydrochloride [mart.]

    90. Sertraline Hydrochloride [vandf]

    91. Ncgc00092386-01

    92. Ncgc00092386-13

    93. Ncgc00261555-01

    94. Sertraline Hydrochloride [usp-rs]

    95. Sertraline Hydrochloride [who-dd]

    96. Bs164399

    97. Sertraline Hydrochloride Impurity Standard

    98. Sertraline Hydrochloride Related Compound A

    99. Sertraline Hydrochloride, >=98% (hplc)

    100. Cp-5197401

    101. Eu-0100870

    102. S4053

    103. Sertraline Hydrochloride [ep Impurity]

    104. Sertraline Hydrochloride [orange Book]

    105. D00825

    106. O12070

    107. Sertraline Hydrochloride [ep Monograph]

    108. Sertraline Hydrochloride [usp Monograph]

    109. 559s970

    110. A839713

    111. Q27108281

    112. Sertraline Hydrochloride 100 Microg/ml In Acetonitrile

    113. Sertraline Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    114. Sertraline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    115. Sertraline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    116. (1s,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthyl(methyl)amine Hydrochloride

    117. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenaminehydrochloride

    118. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hcl

    119. Sertraline For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    120. Sertraline For System Suitability, European Pharmacopoeia (ep) Reference Standard

    121. Sertraline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    122. (1 S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphathalenamine Hydrochloride

    123. (1s,4s)-4-(3,4-dichlorophenyl)-1,2, 3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

    124. (1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphathalenamine Hydrochloride

    125. [(1s,4s)-4-(3,4-dichloro-phenyl)-1,2,3,4-tetrahydro-naphthalen-1-yl]-methyl-amine Hydrochloride

    126. 1-naphthalenamine,?4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, (1s,4s)-, Hydrochloride?(1:1)

    127. Rac-sertraline Hydrochloride ((1rs,4rs)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride)

    128. Sertraline Hydrochloride Racemic Mixture, United States Pharmacopeia (usp) Reference Standard

    129. Sertraline Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 342.7 g/mol
    Molecular Formula C17H18Cl3N
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count2
    Exact Mass341.050483 g/mol
    Monoisotopic Mass341.050483 g/mol
    Topological Polar Surface Area12 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity322
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 NameSertraline hydrochloride
    PubMed HealthSertraline (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelSertraline is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphtha...
    Active IngredientSertraline hydrochloride
    Dosage FormTablet; Concentrate
    Routeoral; Oral
    Strengtheq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; eq 200mg base; eq 20mg base/ml; eq 25mg base
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Wockhardt; Ranbaxy; Sun Pharm Inds (in); Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Lupin; Prosam Labs; Invagen Pharms; Cipla; Hikma Pharms; Watson Labs; Austarpharma; Zydus Pharms Usa; Mylan

    2 of 4  
    Drug NameZoloft
    Drug LabelZOLOFT (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetr...
    Active IngredientSertraline hydrochloride
    Dosage FormTablet; Concentrate
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 20mg base/ml; eq 25mg base
    Market StatusPrescription
    CompanyPfizer

    3 of 4  
    Drug NameSertraline hydrochloride
    PubMed HealthSertraline (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelSertraline is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphtha...
    Active IngredientSertraline hydrochloride
    Dosage FormTablet; Concentrate
    Routeoral; Oral
    Strengtheq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; eq 200mg base; eq 20mg base/ml; eq 25mg base
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Wockhardt; Ranbaxy; Sun Pharm Inds (in); Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Lupin; Prosam Labs; Invagen Pharms; Cipla; Hikma Pharms; Watson Labs; Austarpharma; Zydus Pharms Usa; Mylan

    4 of 4  
    Drug NameZoloft
    Drug LabelZOLOFT (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetr...
    Active IngredientSertraline hydrochloride
    Dosage FormTablet; Concentrate
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 20mg base/ml; eq 25mg base
    Market StatusPrescription
    CompanyPfizer

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Selective Serotonin Reuptake Inhibitors

    Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

    Antidepressive Agents

    Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]

    API Reference Price

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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747593000,"product":"SERTRALINE HCL USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"5393.84","actualQuantity":"5393.84","unit":"KGS","unitRateFc":"105.8","totalValueFC":"578693.9","currency":"USD","unitRateINR":"9141","date":"19-May-2025","totalValueINR":"49305091.44","totalValueInUsd":"578693.9","indian_port":"Vizag-HIPL SEZ","hs_no":"29214990","bill_no":"2139865","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1752517800,"product":"SERTRALINE HYDROCHLORIDE (REJECTED AND RE-IMPORTED MATERIAL, EXPORTED VIDE SB NO: 9885377 DT: 15.05.2024)SERTRALINE HYDROCHLORIDE","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"CHEMO AG., VENNA, LUGANO BRANCH","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"NOSCH LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"898.90","actualQuantity":"898.9","unit":"KGS","unitRateFc":"120.1","totalValueFC":"108158.9","currency":"USD","unitRateINR":"10355.8","date":"15-Jul-2025","totalValueINR":"9308798.33","totalValueInUsd":"108158.9","indian_port":"Hyderabad ICD","hs_no":"29322090","bill_no":"3278395","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"VIA F.PELLI 17 P.O.BOX 6900 LUGANO( SWITZERLAND) LUGANO SDNF Switzerland","customerAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1752517800,"product":"SERTRALINE HYDROCHLORIDE (REJECTED AND RE-IMPORTED MATERIAL,EXPORTED VIDE SB NO: 9375331 DT: 25.04.2024)SERTRALINE HYDROCHLORIDE","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"CHEMO AG., VENNA, LUGANO BRANCH","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"NOSCH LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"120.1","totalValueFC":"180485.5","currency":"USD","unitRateINR":"10355.8","date":"15-Jul-2025","totalValueINR":"15533649.45","totalValueInUsd":"180485.5","indian_port":"Hyderabad ICD","hs_no":"29322090","bill_no":"3278395","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"VIA F.PELLI 17 P.O.BOX 6900 LUGANO( SWITZERLAND) LUGANO SDNF Switzerland","customerAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754505000,"product":"SERTRALINE HYDROCHLORIDE FORM-I EUROPEANPHARMACOPEIA #MANUFACTURER: AUROBINDO PHARMA LTD","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MYLAN LABORATORIES LTD FDF UNIT 3","supplierCountry":"INDIA","foreign_port":"ICD, HYDERABAD","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"123.4","totalValueFC":"122.4","currency":"USD","unitRateINR":"10712","date":"07-Aug-2025","totalValueINR":"10712","totalValueInUsd":"122.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29213090","bill_no":"3738281","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ICD, HYDERABAD","supplierAddress":"Plot No 11,12 & 13, SEZ Phase II, ISEZ Sector 3, Pithampur, Dist Dhar SDNF India","customerAddress":"564\/A\/22, ROAD NO.92"}]
    04-Jan-2022
    30-Aug-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 19839

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19839

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    DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19839

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 19839

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 19839

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    ABOUT THIS PAGE

    Looking for 79559-97-0 / Sertraline Hydrochloride API manufacturers, exporters & distributors?

    Sertraline Hydrochloride manufacturers, exporters & distributors 1

    23

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

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

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

    API | Excipient name

    Sertraline Hydrochloride

    Synonyms

    79559-97-0, Sertraline hcl, Zoloft, Gladem, Lustral, Serad

    Cas Number

    79559-97-0

    Unique Ingredient Identifier (UNII)

    UTI8907Y6X

    About Sertraline Hydrochloride

    A selective serotonin uptake inhibitor that is used in the treatment of depression.

    Altruline Manufacturers

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

    Altruline Suppliers

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

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

    Altruline USDMF

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

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

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

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

    Altruline KDMF

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

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

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

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

    Altruline CEP

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

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

    Altruline WC

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

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

    Altruline 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 Altruline as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Altruline GMP

    Altruline 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 Altruline 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 Altruline GMP manufacturer or Altruline GMP API supplier for your needs.

    Altruline CoA

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

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

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