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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]

    API Reference Price

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Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700677800,"product":"(RE-IMPORT CARGO) VENLAFAXINE HYDROCHLORIDE EP (BATCH NO. 22\/VLX\/003) (ALL OTHER DETAILS AS PER INOVICE AND PACKING LIST","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"SM EMPREENDIMENTOS FARMACEUTICOS ","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"GEMINI 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":"CHEMO","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"AARTI PHARMALABS","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 S.L.","supplierCountry":"SPAIN","foreign_port":"BILBAO","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"4.76","actualQuantity":"4.76","unit":"KGS","unitRateFc":"130","totalValueFC":"634.8","currency":"USD","unitRateINR":"11254.7","date":"02-Nov-2024","totalValueINR":"53572.52","totalValueInUsd":"634.8","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":1735324200,"product":"REIMPORT OF VENLAFAXINE HYDROCHLORIDE PH EXPORTED VIDE SB NO2522804 DATED 18.07.2024 EXPORT INVOICE NO 6770040448VENLAFAXINE HYDROCHLORIDE PH","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"LINDOPHARM GMBH","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"844.58","actualQuantity":"844.576","unit":"KGS","unitRateFc":"84.9","totalValueFC":"72543.7","currency":"USD","unitRateINR":"7298.3","date":"28-Dec-2024","totalValueINR":"6163963.5","totalValueInUsd":"72543.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7512069","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"LABORATORIOS MEDICAMENTOS INTERNACI ONALES S.ASolana no 2628850 Torrej n de Ardoz, MADRAID SPAIN","customerAddress":"ALEMBIC ROAD"}]
    12-Jan-2021
    31-Mar-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

    32

    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.

    Trevilor Manufacturers

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

    Trevilor Suppliers

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

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

    Trevilor USDMF

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

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

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

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

    Trevilor KDMF

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

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

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

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

    Trevilor CEP

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

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

    Trevilor WC

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

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

    Trevilor 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 Trevilor as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Trevilor GMP

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

    Trevilor CoA

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

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

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