Synopsis
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DRUG PRODUCT COMPOSITIONS0
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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
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
| Molecular Weight | 342.7 g/mol |
|---|---|
| Molecular Formula | C17H18Cl3N |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 2 |
| Exact Mass | 341.050483 g/mol |
| Monoisotopic Mass | 341.050483 g/mol |
| Topological Polar Surface Area | 12 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 322 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Sertraline hydrochloride |
| PubMed Health | Sertraline (By mouth) |
| Drug Classes | Antidepressant, Central Nervous System Agent |
| Drug Label | Sertraline 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 Ingredient | Sertraline hydrochloride |
| Dosage Form | Tablet; Concentrate |
| Route | oral; Oral |
| Strength | eq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; eq 200mg base; eq 20mg base/ml; eq 25mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan 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 Name | Zoloft |
| Drug Label | ZOLOFT (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 Ingredient | Sertraline hydrochloride |
| Dosage Form | Tablet; Concentrate |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 20mg base/ml; eq 25mg base |
| Market Status | Prescription |
| Company | Pfizer |
| 3 of 4 | |
|---|---|
| Drug Name | Sertraline hydrochloride |
| PubMed Health | Sertraline (By mouth) |
| Drug Classes | Antidepressant, Central Nervous System Agent |
| Drug Label | Sertraline 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 Ingredient | Sertraline hydrochloride |
| Dosage Form | Tablet; Concentrate |
| Route | oral; Oral |
| Strength | eq 100mg base; 200mg; eq 50mg base; 150mg; eq 150mg base; eq 200mg base; eq 20mg base/ml; eq 25mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan 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 Name | Zoloft |
| Drug Label | ZOLOFT (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 Ingredient | Sertraline hydrochloride |
| Dosage Form | Tablet; Concentrate |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 20mg base/ml; eq 25mg base |
| Market Status | Prescription |
| Company | Pfizer |
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.)
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-968
Start Marketing Date : 2014-04-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 2013-124 - Rev 00
Issue Date : 2019-06-24
Type : Chemical
Substance Number : 1705
Status : Valid
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16125
Submission : 2002-09-06
Status : Inactive
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-06-18
Registration Number : 20130618-39-C-316-11
Manufacturer Name : Teva API India Pvt. Ltd
Manufacturer Address : Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula, Distt. JP Nagar (UP), India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37733
Submission : 2023-04-06
Status : Active
Type : II
Certificate Number : CEP 2022-469 - Rev 00
Issue Date : 2024-08-06
Type : Chemical
Substance Number : 1705
Status : Valid
Date of Issue : 2023-03-21
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm :
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USDMF
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16125
Submission : 2002-09-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17435
Submission : 2004-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17317
Submission : 2004-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14437
Submission : 1999-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15731
Submission : 2001-11-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18239
Submission : 2005-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16752
Submission : 2003-08-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16848
Submission : 2003-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17325
Submission : 2004-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18049
Submission : 2005-02-03
Status : Inactive
Type : II
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 2013-124 - Rev 00
Status : Valid
Issue Date : 2019-06-24
Type : Chemical
Substance Number : 1705
Certificate Number : R0-CEP 2015-139 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-07-09
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2010-059 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-09-04
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2009-115 - Rev 02
Status : Valid
Issue Date : 2016-09-13
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2009-011 - Rev 02
Status : Valid
Issue Date : 2017-02-14
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2008-135 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2014-07-21
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2008-265 - Rev 01
Status : Valid
Issue Date : 2020-05-27
Type : Chemical
Substance Number : 1705
Sertraline Hydrochloride, Form I
Certificate Number : R1-CEP 2010-107 - Rev 02
Status : Valid
Issue Date : 2017-10-17
Type : Chemical
Substance Number : 1705
Certificate Number : R1-CEP 2008-173 - Rev 06
Status : Valid
Issue Date : 2022-04-08
Type : Chemical
Substance Number : 1705
Sertraline Hydrochloride, Form II
Certificate Number : R0-CEP 2013-022 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2015-10-08
Type : Chemical
Substance Number : 1705
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...
About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...
About the Company : Exemed, with due global accreditations from US FDA, KFDA and other regulatory bodies, is one of the leading and cost-competitive manufacturers of Metformin. Besides Metformin we ma...
About the Company : Gennex Laboratories Limited is an Active Pharmaceutical Ingredient manufacturing company, setup in 1995 with its unit located in IDA Bollaram. Gennex is among the leading ‘Vertic...
About the Company : Maisuriya Pharma Solutions is a research-driven & technology-oriented company. Continuous innovations & improvement are the lifeblood of our business. Our major focus is to offer p...
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Regulatory Info :
Registration Country : Australia
Brand Name : Eleva 50
Dosage Form : tablet
Dosage Strength : 50 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eleva 50
Dosage Form : tablet
Dosage Strength : 50 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : APO-Sertraline
Dosage Form : tablet
Dosage Strength : 50 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : NOUMED SERTRALINE
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Sertraline generichealth
Dosage Form : tablet
Dosage Strength : 50 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zoloft
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zoloft
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Blooms The Chemist Sertraline
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Sertraline Sandoz
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Setrona
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 19839
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
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
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 19839
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
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