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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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HDSERNF004,","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"180","totalValueFC":"17587.8","currency":"USD","unitRateINR":"14472","date":"04-Oct-2022","totalValueINR":"1447200","totalValueInUsd":"17587.8","indian_port":"Ranbaxy SEZ\/Mohali","hs_no":"29214990","bill_no":"1000080","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST","supplierAddress":"N\/A","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684521000,"product":"200992 SERTRALINE HCL EP FORM II BATCH TP4304 PHARMACEUTICAL PRODUCTS","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU","city":"BANGALORE","supplier":"APOTEX INC","supplierCountry":"CANADA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"22.08","actualQuantity":"22.08","unit":"KGS","unitRateFc":"201.8","totalValueFC":"3373.7","currency":"CAD","unitRateINR":"12572.7","date":"20-May-2023","totalValueINR":"277606.31","totalValueInUsd":"3373.7","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Canada","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"(RE-IMPORT REJECTED GOODS) SERTRALINE HCL PH. EUR","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"KRKA","supplierCountry":"INDIA","foreign_port":"KOPER","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"401.29","actualQuantity":"401.29","unit":"KGS","unitRateFc":"140","totalValueFC":"60228.3","currency":"USD","unitRateINR":"12589.1","date":"16-Aug-2024","totalValueINR":"5051860.24","totalValueInUsd":"60228.3","indian_port":"JNPT","hs_no":"29420090","bill_no":"5073689","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KOPER","supplierAddress":"SMARJESKA CESTA 6 8501 NOV MESTO SLOVENIASDNF Slovenia","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733250600,"product":"REIMPORT OF SERTRALINE HYDROCHLORIDE USP (BATCH NO.SET400224CD-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,"}]
02-Jan-2021
29-Mar-2025
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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

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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 Manufacturers

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

Sertraline Suppliers

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

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

Sertraline USDMF

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

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

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

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

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

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

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

Sertraline CEP

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

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

Sertraline WC

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

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

Sertraline 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sertraline GMP

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

Sertraline CoA

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

Sertraline CoA mostly includes findings from lab analyses of a specific batch. For each Sertraline 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Sertraline EP), Sertraline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sertraline 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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