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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
    Duloxetine Hydrochloride
    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 Weight 333.9 g/mol
    Molecular Formula C18H20ClNOS
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count6
    Exact Mass333.0954131 g/mol
    Monoisotopic Mass333.0954131 g/mol
    Topological Polar Surface Area49.5 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity312
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    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 NameCymbalta
    PubMed HealthDuloxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent, Neuropathic Pain Agent
    Drug LabelCymbalta (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 IngredientDuloxetine hydrochloride
    Dosage FormCapsule, delayed rel pellets
    Routeoral; Oral
    Strengtheq 30mg base; eq 20mg base; eq 60mg base
    Market StatusPrescription
    CompanyLilly

    2 of 4  
    Drug NameDuloxetine hydrochloride
    Drug LabelCymbalta (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 IngredientDuloxetine hydrochloride
    Dosage FormCapsule, delayed rel pellets; Capsule, delayed release
    Routeoral; Oral
    Strengtheq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; 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 NameCymbalta
    PubMed HealthDuloxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent, Neuropathic Pain Agent
    Drug LabelCymbalta (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 IngredientDuloxetine hydrochloride
    Dosage FormCapsule, delayed rel pellets
    Routeoral; Oral
    Strengtheq 30mg base; eq 20mg base; eq 60mg base
    Market StatusPrescription
    CompanyLilly

    4 of 4  
    Drug NameDuloxetine hydrochloride
    Drug LabelCymbalta (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 IngredientDuloxetine hydrochloride
    Dosage FormCapsule, delayed rel pellets; Capsule, delayed release
    Routeoral; Oral
    Strengtheq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; 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

    N06AX21

    N06AX21

    N06AX21

    N06AX21

    N06AX21

    API Reference Price

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RD., LUZHUDIST TAOYUAN CITY 33856, TAIWAN Taoyuan, , Taiwan Taiwan","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697394600,"product":"DULOXETINE HCL PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NINGBO","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"218.05","actualQuantity":"218.05","unit":"KGS","unitRateFc":"185","totalValueFC":"40785.5","currency":"USD","unitRateINR":"15567.8","date":"16-Oct-2023","totalValueINR":"3394547.89","totalValueInUsd":"40785.5","indian_port":"JNPT","hs_no":"29349990","bill_no":"8321148","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NINGBO","supplierAddress":"TDXUNQIAO,LINHAI,ZHEJIANG,317024,CHINASDNF CHINA","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697394600,"product":"DULOXETINE HYDROCHLORIDE PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NINGBO","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"185","totalValueFC":"187046.5","currency":"USD","unitRateINR":"15567.8","date":"16-Oct-2023","totalValueINR":"15567750","totalValueInUsd":"187046.5","indian_port":"JNPT","hs_no":"29349990","bill_no":"8321148","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NINGBO","supplierAddress":"TDXUNQIAO,LINHAI,ZHEJIANG,317024,CHINASDNF CHINA","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703615400,"product":"DULOXETINE HYDROCHLORIDE PH EUR","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"180","totalValueFC":"181204.1","currency":"USD","unitRateINR":"15084","date":"27-Dec-2023","totalValueINR":"15084000","totalValueInUsd":"181204.1","indian_port":"Madras Sea","hs_no":"29349990","bill_no":"9421841","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"XUNQIAO LINHAI ZHEJIANG CHINA 317024, CHINASDNF CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1711909800,"product":"DULOXETINE HYDROCHLORIDE PH EUR","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"XXEJIXXG HXXHN XXARMXXEUTXXAL XXLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"180","totalValueFC":"181062","currency":"USD","unitRateINR":"15120","date":"01-Apr-2024","totalValueINR":"15120000","totalValueInUsd":"181062","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29349990","bill_no":"1000976","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"DULOXETINE HYDROCHLORIDE","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"SCI PHARMTECH","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2489.00","actualQuantity":"2489","unit":"KGS","unitRateFc":"190","totalValueFC":"478559.8","currency":"USD","unitRateINR":"16026.5","date":"09-May-2024","totalValueINR":"39889958.5","totalValueInUsd":"478559.8","indian_port":"JNPT","hs_no":"29349990","bill_no":"3402811","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"NO. 61, LN 309, HAIHU N. RD., LUZHUDIST TAOYUAN CITY 33856, TAIWAN Taoyuan, , Taiwan Taiwan","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718908200,"product":"DULOXETINE HYDROCHLORIDE USP","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"225","totalValueFC":"2272.1","currency":"USD","unitRateINR":"18967.5","date":"21-Jun-2024","totalValueINR":"189675","totalValueInUsd":"2272.1","indian_port":"Madras Air","hs_no":"29349990","bill_no":"4118129","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"CO LTD, XUNQIAO,LINHAI, ZHEJIANG317024 CHINA","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"}]
    04-Jan-2021
    30-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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

    USFDA APPLICATION NUMBER - 21427

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

    USFDA APPLICATION NUMBER - 21427

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

    USFDA APPLICATION NUMBER - 21427

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    ABOUT THIS PAGE

    Duloxetine Manufacturers

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

    Duloxetine Suppliers

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

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

    Duloxetine USDMF

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

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

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

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

    Duloxetine KDMF

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

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

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

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

    Duloxetine CEP

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

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

    Duloxetine WC

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

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

    Duloxetine 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 Duloxetine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Duloxetine GMP

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

    Duloxetine CoA

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

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

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