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    Chemistry

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    Also known as: 31677-93-7, Bupropion hcl, 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride, Wellbutrin, Amfebutamone hydrochloride, Zyban
    Molecular Formula
    C13H19Cl2NO
    Molecular Weight
    276.20  g/mol
    InChI Key
    HEYVINCGKDONRU-UHFFFAOYSA-N
    FDA UNII
    ZG7E5POY8O
    Bupropion Hydrochloride
    A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
    1 2D Structure

    Bupropion Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H18ClNO.ClH/c1-9(15-13(2,3)4)12(16)10-6-5-7-11(14)8-10;/h5-9,15H,1-4H3;1H
    2.1.3 InChI Key
    HEYVINCGKDONRU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C(=O)C1=CC(=CC=C1)Cl)NC(C)(C)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    ZG7E5POY8O
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (+-)-1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone

    2. Amfebutamone

    3. Bupropion

    4. Bupropion Hydrochloride, (+-)-isomer

    5. Bupropion, (+-)-isomer

    6. Quomen

    7. Wellbutrin

    8. Zyban (anti-smoking)

    9. Zyban (bupropion)

    10. Zyntabac

    2.3.2 Depositor-Supplied Synonyms

    1. 31677-93-7

    2. Bupropion Hcl

    3. 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one Hydrochloride

    4. Wellbutrin

    5. Amfebutamone Hydrochloride

    6. Zyban

    7. Wellbutrin Xl

    8. Wellbutrin Sr

    9. Budeprion

    10. Forfivo Xl

    11. Wellbatrin

    12. Amfebutamone (bupropion) Hcl

    13. Bw 323

    14. Mysimba

    15. Bupropion (hydrochloride)

    16. Bupropion Sr

    17. 2-(tert-butylamino)-3'-chloropropiophenone Hydrochloride

    18. Zg7e5poy8o

    19. Nsc-315851

    20. 31677-93-7 (hcl)

    21. Elontril

    22. Bw-323

    23. 234447-17-7

    24. 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride

    25. 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone Hydrochloride

    26. 1-propanone, 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-, Hydrochloride (1:1), (-)-

    27. Dsstox_cid_24561

    28. Dsstox_rid_80314

    29. Dsstox_gsid_44561

    30. Bupropion Hydrochloride 100 Microg/ml In Acetonitrile

    31. Bupropion Hydrocloride

    32. 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one Hcl

    33. Zyban (pharmaceutical)

    34. Voxra

    35. Budeprion Xl

    36. (+/-)-bupropion; Amfebutamon; Amfebutamone; Aplenzin; Bupropion Sr; Bupropion Xl

    37. Smr000058423

    38. Budeprion Xl 300

    39. Nsc315851

    40. Amfebutamon Hydrochloride

    41. Sr-01000002989

    42. Einecs 250-759-9

    43. Unii-zg7e5poy8o

    44. Nsc 315851

    45. Quomem

    46. Bupropion Hydrochloride [usan]

    47. Wellbutrin Xr

    48. Wellbutrin Retard

    49. Wellbutrin (tn)

    50. Bupropion D9 Hcl

    51. Prestwick_668

    52. Einecs 252-243-9

    53. Mfcd00055209

    54. Zyban (tn)

    55. M-chloro-alpha-tert-butylaminopropiophenone Hydrochloride

    56. Alpha-(tert-butylamino)-m-chloropropiophenone Hydrochloride

    57. M-chloro-alpha-tert-butylaminopropionphenone Hydrochloride

    58. Bupropion Hydrochloride [usan:usp:jan]

    59. (+-)-2-(tert-butylamino)-3'-chloropropiophenone Hydrochloride

    60. (+-)-alpha-tert-butylamino-3-chloropropiophenone Hydrochloride

    61. Amfebutamone (bupropion)

    62. Ncgc00016807-01

    63. Cas-31677-93-7

    64. Chembl1698

    65. Schembl41602

    66. Mls000069376

    67. Mls001401370

    68. Mls002320678

    69. Spectrum1504174

    70. Bupropion Hydrochloride- Bio-x

    71. Bupropion Hydrochloride Solution

    72. Chebi:3220

    73. Dtxsid6044561

    74. Hy-b0403a

    75. Bvf 033

    76. Bw 322u

    77. Cpi-300

    78. Hms1568b20

    79. Hms1922f09

    80. Pharmakon1600-01504174

    81. Bupropion Hydrochloride (jan/usp)

    82. Bcp22394

    83. Bupropion Hydrochloride [mi]

    84. Tox21_110621

    85. Tox21_301844

    86. Tox21_500166

    87. Ac-196

    88. Amfebutamone-hydrochloride(bupropion)

    89. Bupropion Hydrochloride [jan]

    90. Bw-323u66

    91. Ccg-39085

    92. Nsc758686

    93. Propiophenone, 2-(tert-butylamino)-3'-chloro-, Hydrochloride, (+-)-

    94. Bupropion Hydrochloride [hsdb]

    95. Akos015844544

    96. Tox21_110621_1

    97. Ab02273

    98. Bcp9000462

    99. Bupropion Hydrochloride [mart.]

    100. Bupropion Hydrochloride [vandf]

    101. Ccg-100911

    102. Ks-1034

    103. Lp00166

    104. Nc00161

    105. 1-propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, Hydrochloride, (+-)-

    106. Bupropion Hydrochloride [usp-rs]

    107. Bupropion Hydrochloride [who-dd]

    108. Ncgc00015122-11

    109. Ncgc00093650-01

    110. Ncgc00093650-02

    111. Ncgc00093650-03

    112. Ncgc00093650-04

    113. Ncgc00093650-05

    114. Ncgc00180895-01

    115. Ncgc00180895-02

    116. Ncgc00255927-01

    117. Ncgc00260851-01

    118. Propiophenone, Hydrochloride, (.+-.)-

    119. Bb164268

    120. Smr001338824

    121. Bcp0726000049

    122. Am20060780

    123. B-102

    124. B3649

    125. Bupropion Hydrochloride [orange Book]

    126. Eu-0100166

    127. S2452

    128. Sw196823-6

    129. Bupropion Hydrochloride [usp Impurity]

    130. 77b937

    131. Bupropion Hydrochloride [usp Monograph]

    132. D00817

    133. Bupropion Hydrochloride, >=98% (hplc), Solid

    134. Contrave Component Bupropion Hydrochloride

    135. A820950

    136. Bupropion Hydrochloride Component Of Contrave

    137. Sr-01000002989-2

    138. Q27295463

    139. Sr-01000002989-10

    140. (+/-)-2-(t-butylamino)-3'-chloropropiophenone Hydrochloride

    141. 1-propanone,1-dimethylethyl)amino]-, Hydrochloride, (.+-.)-

    142. Bupropion Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    143. (+/-)-2-(tert-butylamino)-3'-chloropropiophenone Hydrochloride

    144. (.+-.)-2-(tert-butylamino)-3'-chloropropiophenone Hydrochloride

    145. 2-(tert-butylamino)-1-(3-chlorophenyl)-1-propanone Hydrochloride

    146. Bupropion Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    147. 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propane, Monohydrochloride

    148. 1-propanone, 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-, Hydrochloride (1:1)

    149. 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one Hydrochloride;bupropion Hcl

    150. Bupropion Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    151. ( Inverted Question Mark)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone Hydrochloride

    152. 1-propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, Hydrochloride, (+/-)-

    153. Bupropion Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.3.3 Other Synonyms

    1. Amfebutamon

    2. Amfebutamona

    3. Amfebutamonum

    4. Aplenzin

    5. Bupropion

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 276.20 g/mol
    Molecular Formula C13H19Cl2NO
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count4
    Exact Mass275.0843696 g/mol
    Monoisotopic Mass275.0843696 g/mol
    Topological Polar Surface Area29.1 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity247
    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 12  
    Drug NameBupropion hydrochloride
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug Labelhydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength300mg; 75mg; 200mg; 100mg; 150mg
    Market StatusPrescription
    CompanyWatson Labs; Wockhardt; Anchen Pharms; Jubilant Generics; Actavis Labs Fl; Apotex; Zydus Pharms Usa; Sandoz; Sun Pharma Global; Mylan; Actavis; Impax Labs

    2 of 12  
    Drug NameForfivo xl
    Drug LabelFORFIVO XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that o...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength450mg
    Market StatusPrescription
    CompanyEdgemont Pharms

    3 of 12  
    Drug NameWellbutrin
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelDESCRIPTIONWELLBUTRINXL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely r...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet
    RouteOral
    Strength75mg; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    4 of 12  
    Drug NameWellbutrin sr
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelWELLBUTRINSR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength200mg; 150mg; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    5 of 12  
    Drug NameWellbutrin xl
    Drug LabelDESCRIPTIONWELLBUTRINXL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely r...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 300mg
    Market StatusPrescription
    CompanyValeant Intl

    6 of 12  
    Drug NameZyban
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelZYBAN (bupropion hydrochloride) SustainedRelease Tablets are a nonnicotine aid to smoking cessation. ZYBAN is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and market...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    7 of 12  
    Drug NameBupropion hydrochloride
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug Labelhydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength300mg; 75mg; 200mg; 100mg; 150mg
    Market StatusPrescription
    CompanyWatson Labs; Wockhardt; Anchen Pharms; Jubilant Generics; Actavis Labs Fl; Apotex; Zydus Pharms Usa; Sandoz; Sun Pharma Global; Mylan; Actavis; Impax Labs

    8 of 12  
    Drug NameForfivo xl
    Drug LabelFORFIVO XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that o...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength450mg
    Market StatusPrescription
    CompanyEdgemont Pharms

    9 of 12  
    Drug NameWellbutrin
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelDESCRIPTIONWELLBUTRINXL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely r...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet
    RouteOral
    Strength75mg; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    10 of 12  
    Drug NameWellbutrin sr
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelWELLBUTRINSR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength200mg; 150mg; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    11 of 12  
    Drug NameWellbutrin xl
    Drug LabelDESCRIPTIONWELLBUTRINXL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely r...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 300mg
    Market StatusPrescription
    CompanyValeant Intl

    12 of 12  
    Drug NameZyban
    PubMed HealthBupropion (By mouth)
    Drug ClassesAntidepressant, Smoking Cessation Agent
    Drug LabelZYBAN (bupropion hydrochloride) SustainedRelease Tablets are a nonnicotine aid to smoking cessation. ZYBAN is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and market...
    Active IngredientBupropion hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    4.2 Drug Indication

    Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (18 years) with an initial Body Mass Index (BMI) of

    - 30 kg/m2 (obese), or

    - 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e. g. , type 2 diabetes, dyslipidaemia, or controlled hypertension)

    Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

    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.)

    Smoking Cessation Agents

    Substances that facilitate the cessation of tobacco smoking. (See all compounds classified as Smoking Cessation Agents.)

    Cytochrome P-450 CYP2D6 Inhibitors

    Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2D6. (See all compounds classified as Cytochrome P-450 CYP2D6 Inhibitors.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Dopamine Uptake Inhibitors [MoA]; Increased Dopamine Activity [PE]; Increased Norepinephrine Activity [PE]; Norepinephrine Uptake Inhibitors [MoA]; Aminoketone [EPC]
    5.3 ATC Code

    A08AA

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    Aarti Pharmalabs

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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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    About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...

    Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, etc.). It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 3 R&D centers and 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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    HRV Pharma

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    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    Bupropion

    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Lupin Manufacturing Solutions

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    Virtual BoothLupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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    Bupropion Hydrochloride

    About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...

    Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of pharma expertise, LMS combines cost efficiency with regulatory excellence. With world-class sites in Dabhasa and Vizag, and an R&D center in Pune, we deliver integrated, sustainable, and globally compliant solutions that accelerate drug development and reduce environmental impact. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Willow Birch Pharma

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    Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

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    Bupropion Hydrochloride

    About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

    Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Chemino Pharma

    India
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    Chemino Pharma

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    Bupropion Hydrochloride

    About the Company : Chemino Pharma’s goal is to be a top supply partner in the pharmaceutical industry with clear focus on quality, safety and affordability. The company manufactures APIs for both h...

    Chemino Pharma’s goal is to be a top supply partner in the pharmaceutical industry with clear focus on quality, safety and affordability. The company manufactures APIs for both human & veterinary use and intermediate chemicals. It has a modern facility with advanced infrastructure and a team of experts with deep industry knowledge. With the acquisition of Shakti Bioscience, Chemino Pharma has broadened its product offerings, manufacturing capabilities and entry into new markets.
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    Guangzhou Tosun Pharmaceutical

    China
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    Bupropion

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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    DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18644

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    DOSAGE - TABLET;ORAL - 75MG **Federal Registe...DOSAGE - TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    USFDA APPLICATION NUMBER - 22497

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    ABOUT THIS PAGE

    Looking for 31677-93-7 / Bupropion Hydrochloride API manufacturers, exporters & distributors?

    Bupropion Hydrochloride manufacturers, exporters & distributors 1

    34

    PharmaCompass offers a list of Bupropion Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bupropion Hydrochloride manufacturer or Bupropion Hydrochloride supplier for your needs.

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

    API | Excipient name

    Bupropion Hydrochloride

    Synonyms

    31677-93-7, Bupropion hcl, 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride, Wellbutrin, Amfebutamone hydrochloride, Zyban

    Cas Number

    31677-93-7

    Unique Ingredient Identifier (UNII)

    ZG7E5POY8O

    About Bupropion Hydrochloride

    A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.

    Zyban (Anti-Smoking) Manufacturers

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

    Zyban (Anti-Smoking) Suppliers

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

    click here to find a list of Zyban (Anti-Smoking) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    Zyban (Anti-Smoking) USDMF

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

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

    click here to find a list of Zyban (Anti-Smoking) suppliers with USDMF on PharmaCompass.

    Zyban (Anti-Smoking) KDMF

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

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

    After submitting a Zyban (Anti-Smoking) 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 Zyban (Anti-Smoking) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Zyban (Anti-Smoking) suppliers with KDMF on PharmaCompass.

    Zyban (Anti-Smoking) WC

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

    click here to find a list of Zyban (Anti-Smoking) suppliers with Written Confirmation (WC) on PharmaCompass.

    Zyban (Anti-Smoking) 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 Zyban (Anti-Smoking) as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Zyban (Anti-Smoking) suppliers with NDC on PharmaCompass.

    Zyban (Anti-Smoking) GMP

    Zyban (Anti-Smoking) 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 Zyban (Anti-Smoking) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zyban (Anti-Smoking) GMP manufacturer or Zyban (Anti-Smoking) GMP API supplier for your needs.

    Zyban (Anti-Smoking) CoA

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

    Zyban (Anti-Smoking) CoA mostly includes findings from lab analyses of a specific batch. For each Zyban (Anti-Smoking) 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.

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