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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.
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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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USDMF
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Sertraline Hydrochloride (IH/USP/BP/Ph.Eur.)
Date of Issue : 2013-08-30
Valid Till : 2016-07-02
Written Confirmation Number : WC-0240
Address of the Firm : Plot No.145-150,153,154A,IDA, Kondapally, Ibrahimpatnam Mandal,Krishna District-...
Sertraline Hydrochloride Ph. Eur
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...
Date of Issue : 2023-03-21
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy. No. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy, Pin-502319, ...
Sertraline Hydrochloride (IH/USP/Ph. Eur.)
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm : Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
Sertraline Hydrochloride (USP/BP/Ph. Eur.)
Date of Issue : 2020-03-13
Valid Till : 2023-01-05
Written Confirmation Number : WC-0384
Address of the Firm : Unit -IV Sy. No. 332,333 & 335, Velimindeu V Chityal Nalgonda District Telangan ...
Sertraline Hydrochloride Ph.Eur
Date of Issue : 2022-06-08
Valid Till : 2025-06-02
Written Confirmation Number : WC-0011nA2
Address of the Firm : Village toansa, P.O Rail Majra, District S.B.S nagar nawanshahar-144533 Punjab I...
Date of Issue : 2013-07-05
Valid Till : 2016-07-02
Written Confirmation Number : WC-0206
Address of the Firm : (Unit-III), Village- Bhagwanpura, Barwala Road, Derabassi, Dist.- S.A.S. Nagar (...
Date of Issue : 2016-07-01
Valid Till : 2019-07-02
Written Confirmation Number : WC-0166
Address of the Firm : Indrad, Kadi, Dist: Mehsana, Gujarat, India
Sertraline Hydrochloride (Ph.Eur)
Date of Issue : 2016-10-26
Valid Till : 2019-10-26
Written Confirmation Number : WC-0389
Address of the Firm : Plot No.7 J.N Pharma City Tadi V Parawada M Vishakhapatnam A.P India
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Average Price (USD/KGS) |
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sertraline Helvepharm
Dosage Form : Film-Coated Tablets
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sertraline Helvepharm
Dosage Form : Film-Coated Tablets
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sertraline Helvepharm
Dosage Form : Film-Coated Tablets
Dosage Strength : 50mg
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Oralin
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Oralin
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info :
Registration Country : Sweden
Brand Name : Sertraline Tiefenbacher
Dosage Form : FILM COATED PILL
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info :
Registration Country : Sweden
Brand Name : Sertraline Tiefenbacher
Dosage Form : FILM COATED PILL
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
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Regulatory Info : Registered in EU
Registration Country : Germany
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : SERTRALINA THINKS
Dosage Form : Film-Coated Tablet
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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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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Fillers, Diluents & Binders
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Brand Name : Calcium Lactate-Glycerol Adduct
Application : Fillers, Diluents & Binders
Excipient Details : Calcium lactate-glycerol adduct is used both as a stabilizer and a binder in tablet formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Polyvinylpyrrolidone
Application : Fillers, Diluents & Binders
Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Pregelatinized Corn Starch
Application : Fillers, Diluents & Binders
Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K30 is used as a binder for tablets and capsules.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone K30
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Category : Direct Compression, Fillers, Diluents & Binders, Film Formers & Plasticizers
Application : Direct Compression, Fillers, Diluents & Binders, Film Formers & Plasticizers
Excipient Details : KoVidone® VA64 is used as a binder in tablets, direct compression binder, matrix formers in amorphous solid dispersions, and film-forming polymer.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone and Vinyl Acetate Copolymer
Coating Systems & Additives
Controlled & Modified Release
Disintegrants & Superdisintegrants
Solubilizers
Direct Compression
Thickeners and Stabilizers
Granulation
Topical
Film Formers & Plasticizers
Parenteral
Lubricants & Glidants
Co-Processed Excipients
Emulsifying Agents
Taste Masking
Rheology Modifiers
API Stability Enhancers
Chewable & Orodispersible Aids
Empty Capsules
Vegetarian Capsules
Coloring Agents
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments
NEWS #PharmaBuzz
18 Apr 2024
// 20MINUTES
https://www.20minutes.fr/economie/4087038-20240418-biogaran-poids-lourd-francais-medicaments-generiques-vendu-groupe-etranger
09 Sep 2022
// HEALTH CANADA
https://recalls-rappels.canada.ca/en/alert-recall/quetiapine-25-mg-affected-lot-quetiapine-25-mg-may-contain-sertraline-50-mg-tablets
06 Oct 2021
// Nancy Lapid REUTERS
https://www.reuters.com/article/us-health-coronavirus-science/booster-shot-improves-immune-response-of-chemotherapy-patients-post-covid-depression-helped-by-widely-used-drugs-idUSKBN2GW282
06 May 2021
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214790
11 Aug 2020
// PRESS RELEASE
https://www.proveris.com/2020/08/11/proveris-scientific-expands-its-laboratory-services-team/
12 Jun 2020
// Dian Zhang USATODAY
https://www.usatoday.com/story/news/2020/06/10/coronavirus-and-fda-drug-shortage-list/5330491002/
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
Health Canada Patents
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Brand Name : ZOLOFT
Patent Number : 2029065
Filing Date : 1990-10-31
Strength per Unit : 100mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Brand Name : ZOLOFT
Patent Number : 2029065
Filing Date : 1990-10-31
Strength per Unit : 150mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Brand Name : ZOLOFT
Patent Number : 2029065
Filing Date : 1990-10-31
Strength per Unit : 200mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Brand Name : ZOLOFT
Patent Number : 2029065
Filing Date : 1990-10-31
Strength per Unit : 25mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
Brand Name : ZOLOFT
Patent Number : 2029065
Filing Date : 1990-10-31
Strength per Unit : 50mg
Dosage Form : Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2010-10-31
Date Granted : 1994-11-08
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
EDQM
CAS Number : 79559-97-0
Quantity Per Vial : 200 mg
Sale Unit : 1
Order Code : Y0000828
Batch No : 3
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 611-71-2
Quantity Per Vial : 15 mg
Sale Unit : 1
Order Code : Y0001285
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
Sertraline for peak identification
CAS Number : 79559-97-0
Quantity Per Vial : 5.4 mg
Sale Unit : 1
Order Code : Y0000866
Batch No : 5
Price (€) : 79
Storage : +5°C ± 3°C
Sertraline for system suitability
CAS Number : 79559-97-0
Quantity Per Vial : 6.2 mg
Sale Unit : 1
Order Code : Y0000867
Batch No : 3
Price (€) : 79
Storage : +5°C ± 3°C
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]USP
Others
CAS Number : 79617-99-5
Quantity Per Vial :
Sale Unit :
Price :
Details : In stock
Monograph :
Storage :
Code/Batch No : S0001.03
CAS Number :
Quantity Per Vial :
Sale Unit :
Price :
Details : In stock
Monograph :
Storage :
Code/Batch No : S0001.18
CAS Number : 79559-98-1
Quantity Per Vial :
Sale Unit :
Price :
Details : In stock
Monograph :
Storage :
Code/Batch No : S0001.06
CAS Number :
Quantity Per Vial :
Sale Unit :
Price :
Details : In stock
Monograph :
Storage :
Code/Batch No : S0001.19
CAS Number : 611-71-2
Quantity Per Vial :
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Details : In stock
Monograph :
Storage :
Code/Batch No : S0001.04
Sertraline Hydrochloride Impurity H
CAS Number : 866018-46-4
Quantity Per Vial :
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Details : In stock
Monograph :
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Code/Batch No : S0001.21
CAS Number : 79560-19-3
Quantity Per Vial :
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Details : In stock
Monograph :
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Code/Batch No : S0001.14
CAS Number : 79560-20-6
Quantity Per Vial :
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Details : In stock
Monograph :
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Code/Batch No : S0001.13
CAS Number : 79559-98-1
Quantity Per Vial :
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Details : Cat No. CS-O-08145 // Impurity
Monograph :
Storage :
Code/Batch No :
CAS Number : 611-71-2
Quantity Per Vial :
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Price :
Details : Cat No. CS-O-08147 // Impurity
Monograph :
Storage :
Code/Batch No :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ANALYTICAL
Analytical Methods
Product Code : KAN99S05-2546WT
Classification : Optical isomers
Product Characteristics : E131206B
Category :
Description :
ABOUT THIS PAGE
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.
A Gladem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gladem, including repackagers and relabelers. The FDA regulates Gladem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gladem 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 Gladem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gladem supplier is an individual or a company that provides Gladem active pharmaceutical ingredient (API) or Gladem finished formulations upon request. The Gladem suppliers may include Gladem API manufacturers, exporters, distributors and traders.
click here to find a list of Gladem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gladem DMF (Drug Master File) is a document detailing the whole manufacturing process of Gladem active pharmaceutical ingredient (API) in detail. Different forms of Gladem DMFs exist exist since differing nations have different regulations, such as Gladem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gladem DMF submitted to regulatory agencies in the US is known as a USDMF. Gladem USDMF includes data on Gladem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gladem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gladem 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 Gladem Drug Master File in Japan (Gladem JDMF) empowers Gladem 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 Gladem JDMF during the approval evaluation for pharmaceutical products. At the time of Gladem 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 Gladem 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 Gladem Drug Master File in Korea (Gladem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gladem. The MFDS reviews the Gladem KDMF as part of the drug registration process and uses the information provided in the Gladem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gladem 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 Gladem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gladem suppliers with KDMF on PharmaCompass.
A Gladem CEP of the European Pharmacopoeia monograph is often referred to as a Gladem Certificate of Suitability (COS). The purpose of a Gladem CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gladem EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gladem to their clients by showing that a Gladem CEP has been issued for it. The manufacturer submits a Gladem CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gladem CEP holder for the record. Additionally, the data presented in the Gladem CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gladem DMF.
A Gladem CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gladem 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 Gladem suppliers with CEP (COS) on PharmaCompass.
A Gladem written confirmation (Gladem WC) is an official document issued by a regulatory agency to a Gladem manufacturer, verifying that the manufacturing facility of a Gladem active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gladem APIs or Gladem finished pharmaceutical products to another nation, regulatory agencies frequently require a Gladem WC (written confirmation) as part of the regulatory process.
click here to find a list of Gladem 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 Gladem as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gladem 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 Gladem 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 Gladem and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gladem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gladem suppliers with NDC on PharmaCompass.
Gladem 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 Gladem 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 Gladem GMP manufacturer or Gladem GMP API supplier for your needs.
A Gladem CoA (Certificate of Analysis) is a formal document that attests to Gladem's compliance with Gladem specifications and serves as a tool for batch-level quality control.
Gladem CoA mostly includes findings from lab analyses of a specific batch. For each Gladem 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.
Gladem may be tested according to a variety of international standards, such as European Pharmacopoeia (Gladem EP), Gladem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gladem USP).
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