Synopsis
Synopsis
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VMF
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
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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
Sertraline Hydrochloride, Process II
Certificate Number : R0-CEP 2022-446 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2023-06-05
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
Sertraline Hydrochloride, Form II
Certificate Number : R0-CEP 2022-313 - Rev 00
Status : Valid
Issue Date : 2022-10-27
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
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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
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USFDA APPLICATION NUMBER - 19839
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USFDA APPLICATION NUMBER - 19839
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US Exclusivities
Exclusivity Code : CGT
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Application Number : 218853
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Application Number : 218853
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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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
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ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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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.
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.
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.
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.
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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.
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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).
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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.
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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.
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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).
The FDA updates the NDC directory daily. The NDC numbers for Sertraline 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 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 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 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.
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).
