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66 API Suppliers, 25 USDMF, 25 CEP/COS, 7 JDMF, 22 EU WC, 14 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

66 API Suppliers
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25 CEP/COS
7 JDMF
22 EU WC
14 KDMF
20 NDC API
30 Listed Suppliers
$ API Reference Price

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6 Drugs in Development

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519 FDF Dossiers, 96 FDA Orange Book, 255 Europe, 54 Canada, 34 Australia, 25 South Africa, 55 Listed Dossiers

519 FDF Dossiers
96 FDA Orange Book
255 Europe
54 Canada
34 Australia
25 South Africa
55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE

drugProductComposition
TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 3 DKSH, 5 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

relatedExcipients
4 SPI Pharma
2 Seqens
3 DKSH
5 Faran Shimi Pharmaceutical
6 Boai NKY Pharmaceuticals Ltd
13 Gangwal Healthcare
6 Nanjing Well Pharmaceutical
1 ACG Worldwide
7 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
23 BASF
1 Clariant
10 Corel Pharma Chem
6 DFE Pharma
2 Finar
12 Gangwal Chemicals
1 Huzhou Sunflower Pharmaceutical
7 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
31 Kerry
3 Kima Chemical
6 Lonza Capsugel
12 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
3 Pharmatrans-Sanaq
6 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
18 Roquette
13 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
12 Sigachi Industries
2 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem

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DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 217 Finished Drug Prices, 9 Annual Reports

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2 US Medicaid Prescriptions
217 Finished Drug Prices
9 Annual Reports

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17 APIs, 6 FDF Dossiers

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PATENTS & EXCLUSIVITIES

5 Health Canada Patents

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5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM , 3 USP , 15 Others

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3 USP
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ANALYTICAL

1 Analytical Methods

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1 Analytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

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CEP/COS

JDMF

EU WC

KDMF

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VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 126

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API

FDF

16INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

519

FDF Dossiers

FDA Orange Book

255

Europe

Canada

Australia

South Africa

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

176,165,910

Annual Reports (USD Million)

2,316

Finished Drug Prices

255 RELATED EXCIPIENT COMPANIES

436EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 79559-97-0, Sertraline hcl, Zoloft, Gladem, Lustral, Serad

Molecular Formula

C₁₇H₁₈Cl₃N

Molecular Weight

342.7 g/mol

InChI Key

BLFQGGGGFNSJKA-XHXSRVRCSA-N

FDA UNII

UTI8907Y6X

A selective serotonin uptake inhibitor that is used in the treatment of depression.

1 2D Structure

Sertraline Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C17H17Cl2N.ClH/c1-20-17-9-7-12(13-4-2-3-5-14(13)17)11-6-8-15(18)16(19)10-11;/h2-6,8,10,12,17,20H,7,9H2,1H3;1H/t12-,17-;/m0./s1

2.1.3 InChI Key

BLFQGGGGFNSJKA-XHXSRVRCSA-N

2.1.4 Canonical SMILES

CNC1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl.Cl

2.1.5 Isomeric SMILES

CN[C@H]1CC[C@H](C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl.Cl

2.2 Other Identifiers

2.2.1 UNII

UTI8907Y6X

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Altruline

2. Apo Sertraline

3. Apo-sertraline

4. Aremis

5. Besitran

6. Gen Sertraline

7. Gen-sertraline

8. Gladem

9. Hydrochloride, Sertraline

10. Lustral

11. Novo Sertraline

12. Novo-sertraline

13. Ratio Sertraline

14. Ratio-sertraline

15. Rhoxal Sertraline

16. Rhoxal-sertraline

17. Sealdin

18. Sertraline

19. Sertraline Hydrochloride (1s-cis)-isomer

20. Zoloft

2.3.2 Depositor-Supplied Synonyms

1. 79559-97-0

2. Sertraline Hcl

3. Zoloft

4. Gladem

5. Lustral

6. Serad

7. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

8. Rac-cis-sertraline Hydrochloride

9. Sertraline.hcl

10. Sertraline (hydrochloride)

11. 79617-95-1

12. Nsc-746308

13. Nsc-758948

14. (+)-sertraline Hydrochloride

15. Sertraline (as Hydrochloride)

16. Sertraline Hydrechloride

17. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

18. Chebi:9124

19. Uti8907y6x

20. Cp-51974-1

21. (+/-)-sertraline Hydrochloride

22. Cp 51,974-1

23. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthylamine Hydrochloride

24. Atruline

25. Tresleen

26. Cp-51,974-1

27. Tatig

28. Dsstox_cid_20243

29. Dsstox_rid_79456

30. Dsstox_gsid_40243

31. 1-naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, Hydrochloride, (1s-cis)-

32. Adjuvin

33. Aremis

34. Mls001401398

35. Mfcd00895772

36. (+)-cis-(1s,4s)-1-methylamino-4-(3,4-dichlorophenyl)tetralin Hydrochloride

37. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-aminium Chloride

38. (1s-cis)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

39. Cis-n-methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenaminehydrochloride

40. Cas-79559-97-0

41. Sertraline Hydrochloride [usan]

42. Ncgc00092386-03

43. Smr000466298

44. C17h17cl2n.hcl

45. Unii-uti8907y6x

46. Serlift

47. Sertraline, Hcl

48. Sertraline Hydrochloride [usan:usp]

49. Zoloft (tn)

50. (1s,4s)-1-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-4-(methylamino)naphthalene Hydrochloride

51. Cpd000466298

52. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride

53. Sertraline Impurity G Hcl

54. Chembl1709

55. Schembl23230

56. Mls000758929

57. Spectrum1505262

58. Sertraline Hydrochloride- Bio-x

59. Dtxsid1040243

60. Hy-b0176a

61. Sertraline For System Suitability

62. (1r,4s)-sertraline Hcl

63. Sertraline For Peak Identification

64. Cp-51974-1 Hcl

65. Hms1922p09

66. Pharmakon1600-01505262

67. (1r,4s)-sertraline Hydrochloride

68. (1rs,4sr)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

69. Sertraline Hydrochloride (jan/usp)

70. Tox21_111199

71. Tox21_500870

72. Ac-740

73. Ccg-39575

74. Nsc746308

75. Nsc758948

76. Sertraline Hydrochloride [mi]

77. Sertraline Hydrochloride [jan]

78. Akos005267232

79. Akos015846322

80. Tox21_111199_1

81. Cs-2052

82. Ks-1111

83. Lp00870

84. Nc00198

85. Nc00726

86. Nsc 746308

87. Nsc 758948

88. (1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

89. Sertraline Hydrochloride [mart.]

90. Sertraline Hydrochloride [vandf]

91. Ncgc00092386-01

92. Ncgc00092386-13

93. Ncgc00261555-01

94. Sertraline Hydrochloride [usp-rs]

95. Sertraline Hydrochloride [who-dd]

96. Bs164399

97. Sertraline Hydrochloride Impurity Standard

98. Sertraline Hydrochloride Related Compound A

99. Sertraline Hydrochloride, >=98% (hplc)

100. Cp-5197401

101. Eu-0100870

102. S4053

103. Sertraline Hydrochloride [ep Impurity]

104. Sertraline Hydrochloride [orange Book]

105. D00825

106. O12070

107. Sertraline Hydrochloride [ep Monograph]

108. Sertraline Hydrochloride [usp Monograph]

109. 559s970

110. A839713

111. Q27108281

112. Sertraline Hydrochloride 100 Microg/ml In Acetonitrile

113. Sertraline Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

114. Sertraline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

115. Sertraline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

116. (1s,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthyl(methyl)amine Hydrochloride

117. (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphthalenaminehydrochloride

118. (1s,4s)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hcl

119. Sertraline For Peak Identification, European Pharmacopoeia (ep) Reference Standard

120. Sertraline For System Suitability, European Pharmacopoeia (ep) Reference Standard

121. Sertraline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

122. (1 S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphathalenamine Hydrochloride

123. (1s,4s)-4-(3,4-dichlorophenyl)-1,2, 3,4-tetrahydro-n-methyl-1-naphthalenamine Hydrochloride

124. (1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-naphathalenamine Hydrochloride

125. [(1s,4s)-4-(3,4-dichloro-phenyl)-1,2,3,4-tetrahydro-naphthalen-1-yl]-methyl-amine Hydrochloride

126. 1-naphthalenamine,?4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-, (1s,4s)-, Hydrochloride?(1:1)

127. Rac-sertraline Hydrochloride ((1rs,4rs)-4-(3,4-dichlorophenyl)-n-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride)

128. Sertraline Hydrochloride Racemic Mixture, United States Pharmacopeia (usp) Reference Standard

129. Sertraline Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₁₈Cl₃N
Molecular Weight	342.7 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Selective Serotonin Reuptake Inhibitors

Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]

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Teva Pharmaceutical Industries Ltd

Israel

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Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Sertraline Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16125

Submission : 2002-09-06

Status : Inactive

Type : II

Product Web Link

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02

Apitoria Pharma Private Ltd

India

Antibody Engineering

Not Confirmed

03

Cipla Ltd

India

Antibody Engineering

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Cipla Ltd

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Moehs Iberica S.L. Rubi ES

Spain

CPhI WW Frankfurt

Booth #11.0C6

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Spain

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Sertraline hydrochloride

Certificate Number : R1-CEP 2013-124 - Rev 00

Status : Valid

Issue Date : 2019-06-24

Type : Chemical

Substance Number : 1705

Product Web Link

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CIPLA LIMITED Mumbai IN

India

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HETERO DRUGS LIMITED Hyderabad IN

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Wanbury Limited Vashi, Navi Mumbai ...

India

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DR. REDDY'S LABORATORIES LIMITED Hy...

Gabon

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 100MG BASE