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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

86 API Suppliers, 43 USDMF, 45 CEP/COS, 3 JDMF, 23 EU WC, 6 KDMF, 21 NDC API, 28 Listed Suppliers, $ API Reference Price

86 API Suppliers
43 USDMF
45 CEP/COS
3 JDMF
23 EU WC
6 KDMF
21 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

453 FDF Dossiers, 177 FDA Orange Book, 199 Europe, 45 Canada, 7 South Africa, 25 Listed Dossiers

453 FDF Dossiers
177 FDA Orange Book
199 Europe
45 Canada
7 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 75MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 225MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 75MG BASE

drugProductComposition
CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE
CAPSULE, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE
CAPSULE, EXTENDED RELEASE;ORAL - EQ 75MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 225MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 3 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 10 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 39 BASF, 2 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 25 Roquette, 17 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus

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

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 49 Direct Compression, 45 Controlled & Modified Release, 45 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 37 Solubilizers, 33 Granulation, 29 Topical, 29 Taste Masking, 25 Lubricants & Glidants, 23 Film Formers & Plasticizers, 23 Co-Processed Excipients, 22 Parenteral, 20 Chewable & Orodispersible Aids, 12 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 27 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 32 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
32 Finished Drug Prices

MARKET PLACE

8 APIs, 1 FDF Dossiers, 1 EXCIPIENTS

marketPlace
8 APIs
1 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

16 Health Canada Patents

patents
16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP

otherSolutions
2 EDQM
1 USP

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 84

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

453

FDF Dossiers

177

FDA Orange Book

199

Europe

Canada

Australia

South Africa

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)

49,779,961

Annual Reports (USD Million)

Finished Drug Prices

374 RELATED EXCIPIENT COMPANIES

653EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 99300-78-4, Venlafaxine hcl, Effexor, Efexor, Effexor xr, Dobupal

Molecular Formula

C₁₇H₂₈ClNO₂

Molecular Weight

313.9 g/mol

InChI Key

QYRYFNHXARDNFZ-UHFFFAOYSA-N

FDA UNII

7D7RX5A8MO

A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT.

1 2D Structure

Venlafaxine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexan-1-ol;hydrochloride

2.1.2 InChI

InChI=1S/C17H27NO2.ClH/c1-18(2)13-16(17(19)11-5-4-6-12-17)14-7-9-15(20-3)10-8-14;/h7-10,16,19H,4-6,11-13H2,1-3H3;1H

2.1.3 InChI Key

QYRYFNHXARDNFZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN(C)CC(C1=CC=C(C=C1)OC)C2(CCCCC2)O.Cl

2.2 Other Identifiers

2.2.1 UNII

7D7RX5A8MO

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)cyclohexanol Hcl

2. Cyclohexanol, 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)-, Hydrochloride

3. Dobupal

4. Efexor

5. Effexor

6. Hydrochloride, Venlafaxine

7. Sila Venlafaxine

8. Sila-venlafaxine

9. Trevilor

10. Vandral

11. Venlafaxine

12. Wy 45,030

13. Wy 45030

14. Wy-45,030

15. Wy-45030

16. Wy45,030

17. Wy45030

2.3.2 Depositor-Supplied Synonyms

1. 99300-78-4

2. Venlafaxine Hcl

3. Effexor

4. Efexor

5. Effexor Xr

6. Dobupal

7. Vandral

8. Venlafaxinehydrochloride

9. Wy-45030

10. Venlafaxine (hydrochloride)

11. Wy 45030

12. Wy-45,030

13. Wy 45030 Hydrochloride

14. 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)cyclohexanol Hydrochloride

15. 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol Hydrochloride

16. Nsc-745751

17. 7d7rx5a8mo

18. Venlafaxine (as Hydrochloride)

19. 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexan-1-ol Hydrochloride

20. Cyclohexanol, 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)-, Hydrochloride

21. 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)cyclohexan-1-ol Hydrochloride

22. 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexan-1-ol;hydrochloride

23. Chebi:9944

24. Venlafaxine Hydrochloride [usan]

25. Venlafaxine Hydorchloride

26. Unii-7d7rx5a8mo

27. C17h27no2.hcl

28. Venlift

29. Vexor

30. D,l-venlafaxine, Hydrochloride

31. Venlafaxine Ea

32. Venlafaxine Xr

33. Effexor Lp

34. Effexor Xl

35. Efexor Xl

36. Venlafaxine, Hcl

37. Effexor (tn)

38. Venlafaxine Hydrochloride [usan:usp]

39. Venlafaxine Hydro Chloride

40. Dsstox_cid_27397

41. Dsstox_rid_82318

42. Dsstox_gsid_47397

43. Schembl41936

44. Mls001401454

45. Chembl1201066

46. Dtxsid8047397

47. Hy-b0196a

48. Bvf-012

49. Amy32694

50. Bcp21401

51. Dl-venlafaxine Hydrochloride- Bio-x

52. Tox21_302508

53. Tox21_500449

54. Nsc745751

55. S1441

56. Venlafaxine Hydrochloride (jan/usp)

57. Venlafaxine Hydrochloride [mi]

58. Akos000280874

59. Akos016340594

60. Ac-1696

61. Ccg-100979

62. Ccg-213270

63. H13v695

64. Ks-5049

65. Lp00449

66. Nc00229

67. Nsc 745751

68. Pw-4112

69. Venlafaxine Hydrochloride [jan]

70. Venlafaxine Hydrochloride [hsdb]

71. Ncgc00256703-01

72. Ncgc00261134-01

73. Venlafaxine Hydrochloride [mart.]

74. Venlafaxine Hydrochloride [vandf]

75. Bv164514

76. Smr000469154

77. Venlafaxine Hydrochloride [usp-rs]

78. Venlafaxine Hydrochloride [who-dd]

79. Cas-99300-78-4

80. Ft-0642395

81. Sw197609-3

82. V0110

83. Pf-00345408

84. D00821

85. Venlafaxine Hydrochloride [ep Impurity]

86. Venlafaxine Hydrochloride [ep Monograph]

87. Venlafaxine Hydrochloride [orange Book]

88. Venlafaxine Hydrochloride [usp Monograph]

89. A845995

90. Venlafaxine Hydrochloride, >=98% (hplc), Powder

91. Venlafaxine Hydrochloride 100 Microg/ml In Methanol

92. Q27108525

93. Venlafaxine Hydrochloride 100 Microg/ml In Acetonitrile

94. 1-[2-dimethylamino-1-(4-methoxyphenyl)ethyl]cyclohexanol -hcl

95. Venlafaxine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

96. 1-[2-(dimethylamino)-1-(4-methoxyph Enyl)ethyl]cyclohexanol Hydrochloride

97. 1-[2-dimethylamino-1-(4-methoxy-phenyl)-ethyl]-cyclohexanol Hydrochloride

98. Venlafaxine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

99. (+/-)-1-(.alpha.-((dimethylamino)methyl)-p-methoxybenzyl)cyclohexanol Hydrochloride

100. (rs)-1-(2-dimethylamino-1-(4-methoxyphenyl)ethyl)cyclohexanol Hydrochloride

101. 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-1-cyclohexanol Hydrochloride

102. Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, Hydrochloride (1:1

103. Venlafaxine For System Suitability, European Pharmacopoeia (ep) Reference Standard

104. Venlafaxine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

105. Venlafaxine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

106. Venlafaxine 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	C₁₇H₂₈ClNO₂
Molecular Weight	313.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	5
Exact Mass	313.1808568 g/mol
Monoisotopic Mass	313.1808568 g/mol
Topological Polar Surface Area	32.7 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	279
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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	Effexor xr
Drug Label	Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or ()-1...
Active Ingredient	Venlafaxine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	eq 150mg base; eq 37.5mg base; eq 75mg base
Market Status	Prescription
Company	Wyeth Pharms

2 of 4
Drug Name	Venlafaxine hydrochloride
PubMed Health	Venlafaxine (By mouth)
Drug Classes	Antidepressant
Drug Label	Venlafaxine hydrochloride extended-release capsules for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (c...
Active Ingredient	Venlafaxine hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release
Route	oral; Oral
Strength	37.5mg; eq 100mg base; eq 225mg base; eq 50mg base; 150mg; eq 150mg base; eq 75mg base; 75mg; eq 25mg base; eq 37.5mg base
Market Status	Tentative Approval; Prescription
Company	Amneal Pharms; Wockhardt; Anchen Pharms; Teva; Alembic Pharms; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Osmotica Pharm; Sun Pharma Global; Vintage; Valeant Bermuda; Zydus Pharms Usa; Dr Reddys Labs; Orchid Hlthcare; Mylan; Impax Labs; Heritage Ph

3 of 4
Drug Name	Effexor xr
Drug Label	Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or ()-1...
Active Ingredient	Venlafaxine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	eq 150mg base; eq 37.5mg base; eq 75mg base
Market Status	Prescription
Company	Wyeth Pharms

4 of 4
Drug Name	Venlafaxine hydrochloride
PubMed Health	Venlafaxine (By mouth)
Drug Classes	Antidepressant
Drug Label	Venlafaxine hydrochloride extended-release capsules for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (c...
Active Ingredient	Venlafaxine hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release
Route	oral; Oral
Strength	37.5mg; eq 100mg base; eq 225mg base; eq 50mg base; 150mg; eq 150mg base; eq 75mg base; 75mg; eq 25mg base; eq 37.5mg base
Market Status	Tentative Approval; Prescription
Company	Amneal Pharms; Wockhardt; Anchen Pharms; Teva; Alembic Pharms; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Osmotica Pharm; Sun Pharma Global; Vintage; Valeant Bermuda; Zydus Pharms Usa; Dr Reddys Labs; Orchid Hlthcare; Mylan; Impax Labs; Heritage Ph

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antidepressive Agents, Second-Generation

A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

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

API SUPPLIERS

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USDMF

01

Cohance Lifesciences Ltd

India

Duphat

Not Confirmed

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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India

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Digital Content

VENLAFAXINE HYDROCHLORIDE USP

GDUFA

DMF Review : Complete

Rev. Date : 2022-11-03

Pay. Date : 2022-10-12

DMF Number : 34507

Submission : 2020-01-11

Status : Active

Type : II

02

Moehs Iberica Sl

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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VENLAFAXINE HYDROCHLORIDE

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-10

Pay. Date : 2013-04-02

DMF Number : 17258

Submission : 2004-03-01

Status : Active

Type : II

03

Aarti Pharmalabs Ltd

India

Duphat

Not Confirmed

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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India

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VENLAFAXINE HYDROCLORIDE

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-12

Pay. Date : 2016-01-28

DMF Number : 19879

Submission : 2006-10-11

Status : Active

Type : II

04

Aarti Pharmalabs Ltd

India

Duphat

Not Confirmed

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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India

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VENLAFAXINE HYDROCHLORIDE POLYMORPH B

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-26

Pay. Date : 2015-07-13

DMF Number : 28433

Submission : 2014-07-28

Status : Active

Type : II

05

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

Booth #6.1A32

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

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Israel

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VENLAFAXINE HYDROCHLORIDE

GDUFA

DMF Review : Complete

Rev. Date : 2012-12-24

Pay. Date : 2012-11-13

DMF Number : 16281

Submission : 2002-12-02

Status : Active

Type : II

Corporate PDF

06

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

Booth #6.1A32

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

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Israel

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VENLAFAXINE HYDROCHLORIDE

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18983

Submission : 2005-11-28

Status : Inactive

Type : II

Corporate PDF

07

Siegfried Ltd

Switzerland

Duphat

Not Confirmed

08

Siegfried Usa Llc

Switzerland

Duphat

Not Confirmed

09

Alza Corp

Country

Duphat

Not Confirmed

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Number of Transactions

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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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Drugs in Development

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 20699

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE

USFDA APPLICATION NUMBER - 20699

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 20699

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 22104

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 225MG BASE

USFDA APPLICATION NUMBER - 22104

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE

USFDA APPLICATION NUMBER - 22104

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 22104

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APIs

USP Grade Venlafaxine HCl (100 kg) API needed in India [ENA21628]

A pharmaceutical company that focuses on the development and manufacturing of granules, pellets, capsules & tablets is looking for suppliers of USP Grade Venlafaxine HCl (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

03 Jan 2025

Venlafaxine HCl (200 g) API needed in India [ENA21320]

A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Venlafaxine HCl (200 g) API for development purposes. The suppliers must support this enquiry with DMF & CoA.

05 Dec 2024

Ph.Eur. Grade Venlafaxine HCl (300 g) API needed in India [ENA19992]

A global pharmaceutical company that focuses on research, development and manufacturing of 1000+ products across wide range of therapeutic categories is looking for suppliers of Ph.Eur. Grade Venlafaxine HCl (300 g) API for development purposes. The suppliers must support this enquiry with CoA.

16 Jul 2024

Venlafaxine HCl API needed in Russia [ENA19699]

A Russian pharmaceutical company that focuses on the production and development of antiseptic and disinfecting drugs is looking for suppliers of Venlafaxine HCl API for commercial purposes. The required quantity is 1.2 kg initially and 50 kg - 1 MT later. The suppliers must support this enquiry with DMF & CoA.

13 Jun 2024

Various APIs needed in Sri Lanka [ENA16092]

A company that focuses on the development and manufacturing of solid dosage forms, oral liquids and parenterals is looking for suppliers of Various APIs for both development & commercial purposes. The suppliers must support this enquiry with CoA. 1. USP Grade Diclofenac Sodium (50 kg) API 2. USP Venlafaxine HCl (100 kg) API 3. USP Grade Oseltamivir Phosphate API 4. IP Grade Zinc Sulfate (100 kg) API 5. BP Grade Metformin HCl (14 MT) API

14 Jan 2023

Venlafaxine Hydrochloride API needed in Japan [ENA12839]

A company that deals in various pharmaceutical products is looking for suppliers of Venlafaxine Hydrochloride API for development purpose. The suppliers must support this enquiry with JDMF.

28 Feb 2022

Venlafaxine HCl API needed in the United States [ENA11933]

A contract manufacturing organization that provides a wide range of services and products from early phase discovery to custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms is looking for suppliers of Venlafaxine HCl (Non-deuterated) API for development purpose. The suppliers must support this enquiry with CoA.

23 Nov 2021

EP Grade Venlafaxine Hydrochloride Extended Release Coated Pellets needed in Latvia [ENA09619]

A leading manufacturer in chemical and pharmaceutical products that specializes in finished dosage formulations including neurology, cardiology, infectology and allergology is looking for suppliers of EP Grade Venlafaxine Hydrochloride (MOQ) Extended Release Coated Pellets for development purposes. The suppliers must support this enquiry with GMP and EUDMF.

01 Feb 2021

Venlafaxine HCl & Lornoxicam APIs needed in India [ENA06385]

A pharmaceutical raw material trading company is looking for suppliers of Venlafaxine HCl (100 kg) API and Lornoxicam (500 g) API. The suppliers must support this enquiry with CoA.

25 Jan 2020

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USP

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BioAnalytical Methods

01

QUINTA-ANALYTICA s.r.o

Venlafaxine Hydrochloride

BIO Partnering at JPM

Not Confirmed

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ABOUT THIS PAGE

Venlafaxine Hydrochloride Manufacturers

A Venlafaxine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Venlafaxine Hydrochloride, including repackagers and relabelers. The FDA regulates Venlafaxine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Venlafaxine Hydrochloride Suppliers

A Venlafaxine Hydrochloride supplier is an individual or a company that provides Venlafaxine Hydrochloride active pharmaceutical ingredient (API) or Venlafaxine Hydrochloride finished formulations upon request. The Venlafaxine Hydrochloride suppliers may include Venlafaxine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Venlafaxine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Venlafaxine Hydrochloride USDMF

A Venlafaxine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Venlafaxine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Venlafaxine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Venlafaxine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Venlafaxine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Venlafaxine Hydrochloride USDMF includes data on Venlafaxine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Venlafaxine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Venlafaxine Hydrochloride suppliers with USDMF on PharmaCompass.

Venlafaxine Hydrochloride JDMF

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 Venlafaxine Hydrochloride Drug Master File in Japan (Venlafaxine Hydrochloride JDMF) empowers Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride suppliers with JDMF on PharmaCompass.

Venlafaxine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Venlafaxine Hydrochloride Drug Master File in Korea (Venlafaxine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Venlafaxine Hydrochloride. The MFDS reviews the Venlafaxine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Venlafaxine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Venlafaxine Hydrochloride suppliers with KDMF on PharmaCompass.

Venlafaxine Hydrochloride CEP

A Venlafaxine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Venlafaxine Hydrochloride Certificate of Suitability (COS). The purpose of a Venlafaxine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Venlafaxine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Venlafaxine Hydrochloride to their clients by showing that a Venlafaxine Hydrochloride CEP has been issued for it. The manufacturer submits a Venlafaxine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Venlafaxine Hydrochloride CEP holder for the record. Additionally, the data presented in the Venlafaxine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Venlafaxine Hydrochloride DMF.

A Venlafaxine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Venlafaxine Hydrochloride WC

A Venlafaxine Hydrochloride written confirmation (Venlafaxine Hydrochloride WC) is an official document issued by a regulatory agency to a Venlafaxine Hydrochloride manufacturer, verifying that the manufacturing facility of a Venlafaxine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Venlafaxine Hydrochloride APIs or Venlafaxine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Venlafaxine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Venlafaxine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Venlafaxine Hydrochloride NDC

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 Venlafaxine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Venlafaxine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Venlafaxine Hydrochloride 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Venlafaxine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Venlafaxine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Venlafaxine Hydrochloride suppliers with NDC on PharmaCompass.

Venlafaxine Hydrochloride GMP

Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride GMP manufacturer or Venlafaxine Hydrochloride GMP API supplier for your needs.

Venlafaxine Hydrochloride CoA

A Venlafaxine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Venlafaxine Hydrochloride's compliance with Venlafaxine Hydrochloride specifications and serves as a tool for batch-level quality control.

Venlafaxine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Venlafaxine Hydrochloride 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.

Venlafaxine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Venlafaxine Hydrochloride EP), Venlafaxine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Venlafaxine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

86 API Suppliers

43 USDMF

45 CEP/COS

3 JDMF

23 EU WC

6 KDMF

21 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

453 FDF Dossiers

177 FDA Orange Book

199 Europe

45 Canada

7 South Africa

25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE

CAPSULE, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE

CAPSULE, EXTENDED RELEASE;ORAL - EQ 75MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 225MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 75MG BASE

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