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    Chemistry

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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]

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EUR (SB NO:3992727 DT:22-07-2020)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"456.35","actualQuantity":"456.35","unit":"KGS","unitRateFc":"128","totalValueFC":"59633.2","currency":"USD","unitRateINR":"10390.8","date":"02-Jul-2022","totalValueINR":"4741825.11","totalValueInUsd":"59633.2","indian_port":"HYDERABAD AIR","hs_no":"29214990","bill_no":"9387545","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666463400,"product":"SERTRALINE HYDROCHLORIDE (REJECTED GOODS VIDE SB NO-3581682DT-18-08-2022)","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"TOWA PHARMACEUTICAL","supplierCountry":"INDIA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"270.18","actualQuantity":"270.18","unit":"KGS","unitRateFc":"650","totalValueFC":"183815","currency":"USD","unitRateINR":"55981.5","date":"23-Oct-2022","totalValueINR":"15125075.92","totalValueInUsd":"183815","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"3014716","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722969000,"product":"SERTRALINE HYDROCHLORIDE (REJECTED AND RE-IMPORTED MATERIAL,EXPORTED VIDE SB NO - 4219469 DT - 27.SEPT.2023)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"CHEMO","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"NOSCH LABS PVT","customerCountry":"INDIA","quantity":"299.70","actualQuantity":"299.7","unit":"KGS","unitRateFc":"117.8","totalValueFC":"36012","currency":"USD","unitRateINR":"10078.9","date":"07-Aug-2024","totalValueINR":"3020632.1","totalValueInUsd":"36012","indian_port":"Hyderabad Air","hs_no":"29322090","bill_no":"4922890","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUARULHOS","supplierAddress":"VIA F.PELLI, 17,P.O. BOX, LUGANO -6901,SDNF Switzerland","customerAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733250600,"product":"REIMPORT OF SERTRALINE HYDROCHLORIDE USP (BATCH NO.SET401123CD-I)(FOC)","address":"1, SHANKAR BHAVAN, FRENCH BRIDGE,","city":"MUMBAI","supplier":"BUSICOM CO LTD","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"INNOREX PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"225.00","actualQuantity":"225","unit":"KGS","unitRateFc":"105.5","totalValueFC":"24823.8","currency":"USD","unitRateINR":"9374.4","date":"04-Dec-2024","totalValueINR":"2109250.02","totalValueInUsd":"24823.8","indian_port":"Bombay Air","hs_no":"29214590","bill_no":"7043141","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGKOK","supplierAddress":"23 SUKHUMVIT 62 YAEK 4 (SOI TAT PRING). SUKHUMVIT ROAD, PRAKANONG TAI, PRAKANONG,BANGKOK 10 THAILAND","customerAddress":"1, SHANKAR BHAVAN, FRENCH BRIDGE,"}]
    04-Jan-2021
    12-Dec-2024
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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**

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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**

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 19839

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

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    ABOUT THIS PAGE

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

    Sertraline Hydrochloride manufacturers, exporters & distributors 1

    95

    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.

    Sertraline Hydrochloride Manufacturers

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

    Sertraline Hydrochloride Suppliers

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

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

    Sertraline Hydrochloride USDMF

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

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

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

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

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

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

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

    Sertraline Hydrochloride CEP

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

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

    Sertraline Hydrochloride WC

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

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

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

    Finished drug products

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

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

    Sertraline Hydrochloride GMP

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

    Sertraline Hydrochloride CoA

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

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

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