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ACTIVE PHARMA INGREDIENTS

108 API Suppliers, 45 USDMF, 28 CEP/COS, 13 JDMF, 19 EU WC, 26 KDMF, 18 NDC API, 58 Listed Suppliers, $ API Reference Price

108 API Suppliers
45 USDMF
28 CEP/COS
13 JDMF
19 EU WC
26 KDMF
18 NDC API
58 Listed Suppliers
$ API Reference Price

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3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

30 Intermediates Suppliers

30 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

584 FDF Dossiers, 98 FDA Orange Book, 282 Europe, 44 Canada, 14 Australia, 30 South Africa, 116 Listed Dossiers

584 FDF Dossiers
98 FDA Orange Book
282 Europe
44 Canada
14 Australia
30 South Africa
116 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

drugProductComposition
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 15 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Clariant, 13 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 11 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 6 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

relatedExcipients
2 Evonik
1 Rochem International Inc
15 SPI Pharma
2 Seqens
15 DKSH
2 Jai Radhe Sales
8 Boai NKY Pharmaceuticals Ltd
10 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
6 Actylis
1 Aeon Procare
2 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
35 BASF
1 Clariant
13 Corel Pharma Chem
3 DFE Pharma
2 Finar
14 Gangwal Chemicals
11 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
31 Kerry
3 Kima Chemical
6 Lonza Capsugel
13 Microlex e.U
2 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
2 Pharmatrans-Sanaq
7 Pluviaendo
2 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
11 Roquette
14 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
6 Sigachi Industries
4 The Dow Chemical Company
3 Ulanqab Kema New Material
2 Valens Pharmachem
2 Vasa Pharmachem
2 Vertellus

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 40 Direct Compression, 40 Controlled & Modified Release, 35 Solubilizers, 32 Disintegrants & Superdisintegrants, 25 Thickeners and Stabilizers, 25 Granulation, 20 Taste Masking, 20 Topical, 20 Parenteral, 17 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 16 Film Formers & Plasticizers, 16 Co-Processed Excipients, 9 Empty Capsules, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Coloring Agents, 5 Surfactant & Foaming Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 50 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
50 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 216 Finished Drug Prices, 14 Annual Reports

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2 US Medicaid Prescriptions
216 Finished Drug Prices
14 Annual Reports

MARKET PLACE

23 APIs, 7 FDF Dossiers

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23 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 6 Health Canada Patents

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16 US Patents
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 10 Others

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3 EDQM
3 USP
10 Others

ANALYTICAL

2 BioAnalytical Methods, 2 Analytical Methods

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2 BioAnalytical Methods
2 Analytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

108

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USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 242

MARKET PLACE

API

FDF

30INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

584

FDF Dossiers

FDA Orange Book

282

Europe

Canada

Australia

South Africa

116

Listed Dossiers

3DRUGS 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)

522,586,364

Annual Reports (USD Million)

7,038

Finished Drug Prices

296 RELATED EXCIPIENT COMPANIES

525EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 136434-34-9, Duloxetine hcl, Cymbalta, (s)-duloxetine hydrochloride, Ariclaim, Xeristar

Molecular Formula

C₁₈H₂₀ClNOS

Molecular Weight

333.9 g/mol

InChI Key

BFFSMCNJSOPUAY-LMOVPXPDSA-N

FDA UNII

9044SC542W

A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.

1 2D Structure

Duloxetine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C18H19NOS.ClH/c1-19-12-11-17(18-10-5-13-21-18)20-16-9-4-7-14-6-2-3-8-15(14)16;/h2-10,13,17,19H,11-12H2,1H3;1H/t17-;/m0./s1

2.1.3 InChI Key

BFFSMCNJSOPUAY-LMOVPXPDSA-N

2.1.4 Canonical SMILES

CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32.Cl

2.1.5 Isomeric SMILES

CNCC[C@@H](C1=CC=CS1)OC2=CC=CC3=CC=CC=C32.Cl

2.2 Other Identifiers

2.2.1 UNII

9044SC542W

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cymbalta

2. Duloxetine

3. Duloxetine Ethanedioate (1:1), (+-)-isomer - T353987

4. Duloxetine Hcl

5. Duloxetine, (+)-isomer

6. Hcl, Duloxetine

7. Hydrochloride, Duloxetine

8. Ly 227942

9. Ly 248686

10. Ly-227942

11. Ly-248686

12. Ly227942

13. Ly248686

14. N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine

15. N-methyl-3-(1-naphthalenyloxy)-3-(2-thiophene)propanamide

2.3.2 Depositor-Supplied Synonyms

1. 136434-34-9

2. Duloxetine Hcl

3. Cymbalta

4. (s)-duloxetine Hydrochloride

5. Ariclaim

6. Xeristar

7. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hydrochloride

8. Duloxetine Hydrochloride [usan]

9. Duloxetine Mylan

10. Duloxetine (hydrochloride)

11. Ly248686 Hcl

12. Ly-248686 Hcl

13. Nsc-759112

14. Cpd000469136

15. Duloxetine (as Hydrochloride)

16. Chebi:31526

17. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride

18. 9044sc542w

19. Yentreve (tn)

20. (+)-(s)-n-methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride

21. Dsstox_cid_26443

22. Dsstox_rid_81618

23. Dsstox_gsid_46443

24. Duloxetine Boehringer Ingelheim

25. Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine Hydrochloride

26. (+)-(s)-n-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride

27. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hcl

28. Smr000469136

29. Dulane 20

30. Cas-136434-34-9

31. Ncgc00164559-01

32. C18h19nos.hcl

33. Unii-9044sc542w

34. Ly 248686 Hcl

35. Cymbalta (tn)

36. Duloxetina Cloridrato

37. Duloxetine Hydrochlorise

38. Duloxetine Lilly

39. Cloridrato De Duloxetina

40. Clorhidrato De Duloxetina

41. Chlorhydrate De Duloxetine

42. Duloxetine Hcl (cymbalta)

43. Mls001401452

44. Mls006010054

45. (s)-duloxetine (hydrochloride)

46. Duloxetine Hydrochloride- Bio-x

47. Chembl1200328

48. Dtxsid9046443

49. Duloxetine Hydrochloride Solution

50. Duloxetine For System Suitability

51. Hy-b0161a

52. Pharmakon1600-01505387

53. Ly-248686 Hydrochloride

54. Amy12420

55. Duloxetine Hydrochloride (jan/usp)

56. Tox21_112188

57. Ac-924

58. Duloxetine Hydrochloride [mi]

59. Mfcd06407958

60. Nsc744012

61. Nsc759112

62. S2084

63. Duloxetine Hydrochloride [jan]

64. (3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine Hydrochloride

65. Akos016340453

66. Tox21_112188_1

67. Ccg-101106

68. Cs-1993

69. Ks-1168

70. Nc00356

71. Nsc 759112

72. Nsc-744012

73. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine Hydrochloride

74. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (gammas)-

75. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (s)-

76. Duloxetine Hydrochloride [mart.]

77. Duloxetine Hydrochloride [usp-rs]

78. Duloxetine Hydrochloride [who-dd]

79. Ncgc00164559-03

80. (s)-(+)-duloxetine Hydrochloride

81. Bd165546

82. Ly-264453

83. D-170

84. D4223

85. Sw197393-3

86. Duloxetine Hydrochloride [orange Book]

87. (s)-duloxetine Hydrochloride, >=98% (hplc)

88. D01179

89. Duloxetine Hydrochloride [ep Monograph]

90. Duloxetine Hydrochloride [usp Monograph]

91. 434d349

92. Q-102508

93. Duloxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

94. (+)-(s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine Hydrochloride

95. Duloxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

96. (+)-(s)-n-methyl-3-(1-naphthyloxy)- 3-(2-thienyl)propanamine Hydrochloride

97. (3s)-n-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine Hydrochloride

98. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin Hydrochloride.

99. (gammas)-2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)hydrochloride (1:1)

100. (gammas)-n-methyl-gamma-(1-naphthalenyloxy)-2-thiophenepropanamine Hydrochloride

101. (s)-(+)-n-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) Propanamine Hydrochloride

102. (s)-(+)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine Hydrochloride

103. 2-thiophenepropanamine, N-methyl-.gamma.-(1-naphthalenyloxy)-, Hydrochloride, (s)-

104. Duloxetine For System Suitability, European Pharmacopoeia (ep) Reference Standard

105. Duloxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

106. Duloxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₀ClNOS
Molecular Weight	333.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	6
Exact Mass	333.0954131 g/mol
Monoisotopic Mass	333.0954131 g/mol
Topological Polar Surface Area	49.5 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	312
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
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	Cymbalta
PubMed Health	Duloxetine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent, Neuropathic Pain Agent
Drug Label	Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active Ingredient	Duloxetine hydrochloride
Dosage Form	Capsule, delayed rel pellets
Route	oral; Oral
Strength	eq 30mg base; eq 20mg base; eq 60mg base
Market Status	Prescription
Company	Lilly

2 of 4
Drug Name	Duloxetine hydrochloride
Drug Label	Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active Ingredient	Duloxetine hydrochloride
Dosage Form	Capsule, delayed rel pellets; Capsule, delayed release
Route	oral; Oral
Strength	eq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
Market Status	Tentative Approval; Prescription
Company	Wockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs

3 of 4
Drug Name	Cymbalta
PubMed Health	Duloxetine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent, Neuropathic Pain Agent
Drug Label	Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active Ingredient	Duloxetine hydrochloride
Dosage Form	Capsule, delayed rel pellets
Route	oral; Oral
Strength	eq 30mg base; eq 20mg base; eq 60mg base
Market Status	Prescription
Company	Lilly

4 of 4
Drug Name	Duloxetine hydrochloride
Drug Label	Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active Ingredient	Duloxetine hydrochloride
Dosage Form	Capsule, delayed rel pellets; Capsule, delayed release
Route	oral; Oral
Strength	eq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
Market Status	Tentative Approval; Prescription
Company	Wockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs

4.2 Drug Indication

- Treatment of major depressive disorder;

- Treatment of diabetic peripheral neuropathic pain;

- Treatment of generalised anxiety disorder;

- Duloxetine Mylan is indicated in adults.

Duloxetine Lilly is indicated in adults for:

- Treatment of major depressive disorder

- Treatment of diabetic peripheral neuropathic pain

- Treatment of generalised anxiety disorder

Duloxetine Lilly is indicated in adults.

Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).

Treatment of major depressive disorder.

Treatment of diabetic peripheral neuropathic pain.

Treatment of generalised anxiety disorder.

Cymbalta is indicated in adults.

Treatment of diabetic peripheral neuropathic pain.

Ariclaim is indicated in adults.

Treatment of diabetic peripheral neuropathic pain in adults.

Treatment of chronic pain, Treatment of diabetic neuropathic pain, Treatment of generalised anxiety disorder, Treatment of major depressive disorder, Treatment of stress urinary incontinence

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

Analgesics

Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)

Serotonin and Noradrenaline Reuptake Inhibitors

Drugs that selectively block or suppress the plasma membrane transport of SEROTONIN and NORADRENALINE into axon terminals and are used as ANTIDEPRESSIVE AGENTS. (See all compounds classified as Serotonin and Noradrenaline Reuptake Inhibitors.)

Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin Uptake Inhibitors [MoA]; Serotonin and Norepinephrine Reuptake Inhibitor [EPC]; Norepinephrine Uptake Inhibitors [MoA]

5.3 ATC Code

N06AX21

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Duloxetine hydrochloride

Registration Number : 302MF10013

Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain

Initial Date of Registration : 2020-01-27

Latest Date of Registration : 2020-01-27

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SCI Pharmtech, Inc.

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Duloxetine Hydrochloride

Registration Number : 229MF10017

Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan

Initial Date of Registration : 2017-01-25

Latest Date of Registration : 2017-01-25

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Israel

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India

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API Reference Price

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Number of Transactions

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

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

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DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 21427

DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE

USFDA APPLICATION NUMBER - 21427

DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 21427

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CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

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1 Shijiazhuang Huaxu Pharmaceutical

6 Sigachi Industries

4 The Dow Chemical Company

3 Ulanqab Kema New Material

2 Valens Pharmachem

2 Vasa Pharmachem

2 Vertellus

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders