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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

Venlafaxine Hydrochloride
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 Weight 313.9 g/mol
Molecular Formula C17H28ClNO2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass313.1808568 g/mol
Monoisotopic Mass313.1808568 g/mol
Topological Polar Surface Area32.7 Ų
Heavy Atom Count21
Formal Charge0
Complexity279
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameEffexor xr
Drug LabelEffexor 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 IngredientVenlafaxine hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strengtheq 150mg base; eq 37.5mg base; eq 75mg base
Market StatusPrescription
CompanyWyeth Pharms

2 of 4  
Drug NameVenlafaxine hydrochloride
PubMed HealthVenlafaxine (By mouth)
Drug ClassesAntidepressant
Drug LabelVenlafaxine 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 IngredientVenlafaxine hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule, extended release
Routeoral; Oral
Strength37.5mg; 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 StatusTentative Approval; Prescription
CompanyAmneal 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 NameEffexor xr
Drug LabelEffexor 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 IngredientVenlafaxine hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strengtheq 150mg base; eq 37.5mg base; eq 75mg base
Market StatusPrescription
CompanyWyeth Pharms

4 of 4  
Drug NameVenlafaxine hydrochloride
PubMed HealthVenlafaxine (By mouth)
Drug ClassesAntidepressant
Drug LabelVenlafaxine 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 IngredientVenlafaxine hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule, extended release
Routeoral; Oral
Strength37.5mg; 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 StatusTentative Approval; Prescription
CompanyAmneal 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]

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EXPORTS","customerCountry":"INDIA","quantity":"119.86","actualQuantity":"119.858","unit":"KGS","unitRateFc":"62","totalValueFC":"7593.1","currency":"USD","unitRateINR":"5275.3","date":"23-Nov-2023","totalValueINR":"632283.8","totalValueInUsd":"7593.1","indian_port":"JNPT","hs_no":"29093019","bill_no":"8904168","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"DAVIA PRIMARIA 5-D QD 10 MOD.01S\/N-DAIA ZIP CODE 75132-120 \/ANAPOLIS-GO-BRAZIL BRAZIL","customerAddress":"A-201\/202, NAVBHARAT EST.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"VENLAFAXINE HYDROCHLORIDE PH.EUR.(POLYMORPH B)(RE-IMPORT)","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"LABORATORIOS LICONSA SA","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"AARTI PHARMALABS LIMITED","customerCountry":"INDIA","quantity":"445.77","actualQuantity":"445.77","unit":"KGS","unitRateFc":"79","totalValueFC":"35571.2","currency":"USD","unitRateINR":"6663.7","date":"11-Apr-2024","totalValueINR":"2970455.26","totalValueInUsd":"35571.2","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"2977481","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"AVDA. MIRALCAMPO 7-POLIG.IND.DEMIRALCAMPO 19200 AZUQUECA DE HENARES-GUADALAJARA-SPAIN SPAIN","customerAddress":"2ND FLOOR, GODOWN No. 204"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"VENLAFAXINE HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MOEHS CANTABRA SL","supplierCountry":"SPAIN","foreign_port":"BILBAO","customer":"ALKEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"42.61","actualQuantity":"42.61","unit":"KGS","unitRateFc":"130","totalValueFC":"5682.8","currency":"USD","unitRateINR":"11254.7","date":"02-Nov-2024","totalValueINR":"479564.13","totalValueInUsd":"5682.8","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"6457818","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BILBAO","supplierAddress":"POLIGONO IND.REQUEJADA Z-23 CORRESP OND C\/ROMA 8-12 08191-RUBI BARCELON 39313 POLANCO, , SPAIN SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"VENLAFAXINE HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MOEHS CANTABRA SL","supplierCountry":"SPAIN","foreign_port":"BILBAO","customer":"ALKEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"53.28","actualQuantity":"53.28","unit":"KGS","unitRateFc":"130","totalValueFC":"7105.9","currency":"USD","unitRateINR":"11254.7","date":"02-Nov-2024","totalValueINR":"599652.12","totalValueInUsd":"7105.9","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"6457818","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BILBAO","supplierAddress":"POLIGONO IND.REQUEJADA Z-23 CORRESP OND C\/ROMA 8-12 08191-RUBI BARCELON 39313 POLANCO, , SPAIN SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"VENLAFAXINE HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MOEHS CANTABRA SL","supplierCountry":"SPAIN","foreign_port":"BILBAO","customer":"ALKEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"124.46","actualQuantity":"124.46","unit":"KGS","unitRateFc":"130","totalValueFC":"16599.1","currency":"USD","unitRateINR":"11254.7","date":"02-Nov-2024","totalValueINR":"1400763.93","totalValueInUsd":"16599.1","indian_port":"Delhi Air","hs_no":"29411090","bill_no":"6457818","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BILBAO","supplierAddress":"POLIGONO IND.REQUEJADA Z-23 CORRESP OND C\/ROMA 8-12 08191-RUBI BARCELON 39313 POLANCO, , SPAIN SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"}]
11-Jan-2022
29-Apr-2025
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 20699

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

USFDA APPLICATION NUMBER - 20699

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

USFDA APPLICATION NUMBER - 20699

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

USFDA APPLICATION NUMBER - 22104

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

USFDA APPLICATION NUMBER - 22104

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

USFDA APPLICATION NUMBER - 22104

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

USFDA APPLICATION NUMBER - 22104

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ABOUT THIS PAGE

Looking for 99300-78-4 / Venlafaxine Hydrochloride API manufacturers, exporters & distributors?

Venlafaxine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Venlafaxine 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 Venlafaxine Hydrochloride manufacturer or Venlafaxine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Venlafaxine Hydrochloride manufacturer or Venlafaxine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Venlafaxine Hydrochloride API Price utilized in the formulation of products. Venlafaxine Hydrochloride API Price is not always fixed or binding as the Venlafaxine Hydrochloride Price is obtained through a variety of data sources. The Venlafaxine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Venlafaxine Hydrochloride

Synonyms

99300-78-4, Venlafaxine hcl, Effexor, Efexor, Effexor xr, Dobupal

Cas Number

99300-78-4

Unique Ingredient Identifier (UNII)

7D7RX5A8MO

About Venlafaxine Hydrochloride

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

Effexor Manufacturers

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

Effexor Suppliers

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

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

Effexor USDMF

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

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

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

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

Effexor KDMF

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

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

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

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

Effexor CEP

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

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

Effexor WC

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

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

Effexor 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 Effexor as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Effexor 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 Effexor 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 Effexor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Effexor NDC to their finished compounded human drug products, they may choose to do so.

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

Effexor GMP

Effexor 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 Effexor 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 Effexor GMP manufacturer or Effexor GMP API supplier for your needs.

Effexor CoA

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

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

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