Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Weekly News Recap #Phispers
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.)
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Certificate Number : CEP 2024-117 - Rev 03
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Type : Chemical
Substance Number : 1705
Status : Valid
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Start Marketing Date : 2025-10-06
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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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Registration Number : 226MF10098
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Initial Date of Registration : 2014-05-14
Latest Date of Registration : 2015-04-22
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Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2015-05-14
Sertraline hydrochloride For manufacturing purposes only
Registration Number : 226MF10157
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
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Initial Date of Registration : 2013-12-03
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Sertraline Hydrochloride BP/IP/USP/Ph. Eur.
Date of Issue : 2025-08-01
Valid Till : 2028-08-12
Written Confirmation Number : WC-0077
Address of the Firm : Block no. 422, ECP Canal Road, Village - Luna, Tal — Padra Dist: Vadodara, Guj...
Sertraline Hydrochloride Ph.Eur
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...
Date of Issue : 2025-08-08
Valid Till : 2028-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...
Sertraline Hydrochloride EP/USP
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm : Unit-l, Sy. No. 213, 214 & 255, Bonthapally (Village),Gummadidala (Mandal), Sang...
Sertraline Hydrochloride USP/Ph.Eur
Date of Issue : 2022-09-30
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...
Sertraline Hydrochloride Ph. Eur
Date of Issue : 2025-06-30
Valid Till : 2028-06-22
Written Confirmation Number : WC-014
Address of the Firm : Situated at Chemical Division, Mekaguda (Village), Nandigama (Mandal), Ranga Red...
Sertraline Hydrochloride USP/BP/Ph.Eur
Date of Issue : 2022-12-30
Valid Till : 2026-01-05
Written Confirmation Number : WC-0384
Address of the Firm : UNIT-IV, Sy No. 332, 333 & 335 Veliminedu (Village), Chityal (Mandal), Nalgonda ...
Date of Issue : 2025-11-06
Valid Till : 2028-07-28
Written Confirmation Number : WC-0056
Address of the Firm : 25 MIDC Land, Thane Belapur Road, Navi Mumbai - 400703, Taluka: Pawvane, Distric...
Sertraline Hydrochloride Ph. Eur./USP
Date of Issue : 2025-08-05
Valid Till : 2028-06-02
Written Confirmation Number : WC-0011
Address of the Firm : Village Toansa, P.O. Rail Majra, Tehsil Balachaur, District S.B.S. Nagar (Punjab...
Sertraline Hydrochloride USP/EP
Date of Issue : 2025-10-08
Valid Till : 2028-06-26
Written Confirmation Number : WC-0016
Address of the Firm : (Unit-9) Plot No.5, Road No. 12, Jawaharlal Nehru Pharma City, Tadi Village, Par...
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Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-06-18
Registration Number : 20130618-39-C-316-11
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NDC Package Code : 62512-0080
Start Marketing Date : 2023-05-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65862-222
Start Marketing Date : 2024-01-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 77777-108
Start Marketing Date : 2023-05-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 77777-108
Start Marketing Date : 2018-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 65977-0002
Start Marketing Date : 1996-03-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0148
Start Marketing Date : 1991-12-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0149
Start Marketing Date : 1991-12-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84206-0114
Start Marketing Date : 2025-09-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65427-009
Start Marketing Date : 2014-07-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
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...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...
About the Company : RPG Life Sciences, a part of the USD 3 Billion RPG Enterprises, is an integrated pharmaceutical company operating in the Branded Formulations, Global Generics, Synthetic and Fermen...
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ABOUT THIS PAGE
23
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 HCL (2) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SERTRALINE HCL (2), including repackagers and relabelers. The FDA regulates SERTRALINE HCL (2) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SERTRALINE HCL (2) 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 HCL (2) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SERTRALINE HCL (2) supplier is an individual or a company that provides SERTRALINE HCL (2) active pharmaceutical ingredient (API) or SERTRALINE HCL (2) finished formulations upon request. The SERTRALINE HCL (2) suppliers may include SERTRALINE HCL (2) API manufacturers, exporters, distributors and traders.
click here to find a list of SERTRALINE HCL (2) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SERTRALINE HCL (2) DMF (Drug Master File) is a document detailing the whole manufacturing process of SERTRALINE HCL (2) active pharmaceutical ingredient (API) in detail. Different forms of SERTRALINE HCL (2) DMFs exist exist since differing nations have different regulations, such as SERTRALINE HCL (2) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SERTRALINE HCL (2) DMF submitted to regulatory agencies in the US is known as a USDMF. SERTRALINE HCL (2) USDMF includes data on SERTRALINE HCL (2)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SERTRALINE HCL (2) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SERTRALINE HCL (2) 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 HCL (2) Drug Master File in Japan (SERTRALINE HCL (2) JDMF) empowers SERTRALINE HCL (2) 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 HCL (2) JDMF during the approval evaluation for pharmaceutical products. At the time of SERTRALINE HCL (2) 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 HCL (2) 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 HCL (2) Drug Master File in Korea (SERTRALINE HCL (2) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SERTRALINE HCL (2). The MFDS reviews the SERTRALINE HCL (2) KDMF as part of the drug registration process and uses the information provided in the SERTRALINE HCL (2) KDMF to evaluate the safety and efficacy of the drug.
After submitting a SERTRALINE HCL (2) 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 HCL (2) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SERTRALINE HCL (2) suppliers with KDMF on PharmaCompass.
A SERTRALINE HCL (2) CEP of the European Pharmacopoeia monograph is often referred to as a SERTRALINE HCL (2) Certificate of Suitability (COS). The purpose of a SERTRALINE HCL (2) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SERTRALINE HCL (2) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SERTRALINE HCL (2) to their clients by showing that a SERTRALINE HCL (2) CEP has been issued for it. The manufacturer submits a SERTRALINE HCL (2) CEP (COS) as part of the market authorization procedure, and it takes on the role of a SERTRALINE HCL (2) CEP holder for the record. Additionally, the data presented in the SERTRALINE HCL (2) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SERTRALINE HCL (2) DMF.
A SERTRALINE HCL (2) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SERTRALINE HCL (2) 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 HCL (2) suppliers with CEP (COS) on PharmaCompass.
A SERTRALINE HCL (2) written confirmation (SERTRALINE HCL (2) WC) is an official document issued by a regulatory agency to a SERTRALINE HCL (2) manufacturer, verifying that the manufacturing facility of a SERTRALINE HCL (2) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SERTRALINE HCL (2) APIs or SERTRALINE HCL (2) finished pharmaceutical products to another nation, regulatory agencies frequently require a SERTRALINE HCL (2) WC (written confirmation) as part of the regulatory process.
click here to find a list of SERTRALINE HCL (2) 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 HCL (2) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SERTRALINE HCL (2) 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 HCL (2) 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 HCL (2) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SERTRALINE HCL (2) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SERTRALINE HCL (2) suppliers with NDC on PharmaCompass.
SERTRALINE HCL (2) 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 HCL (2) 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 HCL (2) GMP manufacturer or SERTRALINE HCL (2) GMP API supplier for your needs.
A SERTRALINE HCL (2) CoA (Certificate of Analysis) is a formal document that attests to SERTRALINE HCL (2)'s compliance with SERTRALINE HCL (2) specifications and serves as a tool for batch-level quality control.
SERTRALINE HCL (2) CoA mostly includes findings from lab analyses of a specific batch. For each SERTRALINE HCL (2) 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 HCL (2) may be tested according to a variety of international standards, such as European Pharmacopoeia (SERTRALINE HCL (2) EP), SERTRALINE HCL (2) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SERTRALINE HCL (2) USP).
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