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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

    EU WC

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    Bupropion Hydrochloride USP

    Date of Issue : 2022-09-01

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0074Amended

    Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India

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    06

    Chemeca Drugs

    India
    STLE Annual Meeting
    Not Confirmed
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    Chemeca Drugs

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
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    • WHO-GMP
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    Bupropion Hydrochloride USP

    Date of Issue : 2023-10-25

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-0482

    Address of the Firm : Address: Plot No.7, J N Pharma City Sy.No. 156-161, Thadi (V), Parawada Mandal, ...

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    07

    Chemino Pharma

    India
    STLE Annual Meeting
    Not Confirmed
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    Chemino Pharma

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
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    Bupropion Hydrochloride IP/USP

    Date of Issue : 2024-09-20

    Valid Till : 2027-09-20

    Written Confirmation Number : WC-592

    Address of the Firm : Plot No. 411/1 & 412/2, L.I.C. Sector, Silvassa Road, G.I.D.C. Vapi,396 195. Dis...

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    08

    Hetero Drugs

    India
    STLE Annual Meeting
    Not Confirmed
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    Hetero Drugs

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Bupropion Hydrochloride (USP)

    Date of Issue : 2019-08-09

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0066

    Address of the Firm : Plot No. 1, Hetero SEZ Infrastructure Ltd., Narasapuram, Visakhapatnam-531 081, ...

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    09

    Hikal

    India
    STLE Annual Meeting
    Not Confirmed
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    Hikal

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Bupropion Hydrochloride USP

    Date of Issue : 2022-06-14

    Valid Till : 2025-09-02

    Written Confirmation Number : WC-0094nA2A

    Address of the Firm : Plot No . 72 & 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bengaluru-560 ...

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    10

    Jubilant Pharmova

    India
    STLE Annual Meeting
    Not Confirmed
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    Jubilant Pharmova

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Bupropion Hydrochloride (IH)

    Date of Issue : 2022-09-01

    Valid Till : 2024-11-04

    Written Confirmation Number : WC-0092

    Address of the Firm : Plot No. 18, 56, 57 & 58, K.I.A.D.B. Industrial Area\r\nNanjangud - 571 302, Mys...

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    Listed Suppliers

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    01

    LGM Pharma

    U.S.A
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    CPhI North America
    Booth #1147
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Bupropion Hydrochloride

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    02

    Granules India Limited

    India
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    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Bupropion Hydrochloride

    About the Company : Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufact...

    Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain—APIs, Formulation Intermediates, & Formulations. With 10 facilities (8 in India, 2 in the US) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & the UK, ensuring a strong global presence.Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
    Granules India

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    03

    Jai Radhe Sales

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Bupropion Hydrochloride

    About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

    Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
    Jai Radhe Sales

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    04

    Laboratorium Ofichem B.V

    Netherlands
    arrow
    BIO International Convention
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLaboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

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    Bupropion

    About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...

    Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture small molecule APIs in a cost-effective, robust, and compliant way. We have our own portfolio of generic APIs, but we also operate as a CDMO for a wide range of customers. We are a stable family-owned business and with nearly 50 years of experience we have a long history of regulatory compliance and a strong reputation for reliability and quality.
    Ofichem Company Banner

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    05

    Aarti Pharmalabs

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

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    Bupropion Hydrochloride

    About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...

    Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.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
    Aarti Industries Company Banner

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    06

    HRV Global Life Sciences

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Bupropion

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    07

    Aspire Lifesciences Pvt Ltd

    India
    STLE Annual Meeting
    Not Confirmed
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    Aspire Lifesciences Pvt Ltd

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Bupropion Hydrochloride

    About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

    Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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    08

    Erregierre SpA

    Italy
    STLE Annual Meeting
    Not Confirmed
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    Erregierre SpA

    Italy
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    STLE Annual Meeting
    Not Confirmed
    • fda
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    Bupropion Hydrochloride

    About the Company : ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIE...

    ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIERRE we employ more than 220 people and two manufacturing sites, San Paolo d’Argon and Sovere, are both FDA inspected with no 483 form. We provide APIs of the highest quality and we are a reliable partner for the pharmaceutical industry worldwide.
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    09

    Freemen Nutra

    China
    STLE Annual Meeting
    Not Confirmed
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    Freemen Nutra

    China
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    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Bupropion Hydrochloride

    About the Company : At Freemen Nutra, the focus is on empowering both individuals and customers to achieve greater success. The company specializes in providing high-quality nutritional ingredients an...

    At Freemen Nutra, the focus is on empowering both individuals and customers to achieve greater success. The company specializes in providing high-quality nutritional ingredients and solutions for various industries, including food and beverage, dietary supplements, personal care, and animal nutrition. Freemen Nutra is dedicated to assisting clients in these markets to bring their innovative ideas to fruition. The company stands out as a leading distributor of raw ingredients, offering ethically sourced and exceptional ingredients that contribute to improved product performance, taste, and nutritional benefits for brands.
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    10

    Hetero Drugs

    India
    STLE Annual Meeting
    Not Confirmed
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    Hetero Drugs

    India
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    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Bupropion Hydrochloride

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    API Reference Price

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ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"RETURN GOODS BUPROPION HCL USP43 (S\/B NO.5224532 DT .08.11.2023)","address":"101,MEWAD,E S PATANWALA COMPLEX,","city":"GHATKOPAR[W],MUMBAI,MAHARASHTRA","supplier":"SM EMPREENDIMENTOS FARMAC?UTICOS LTDA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"ATMAN PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"74.99","actualQuantity":"74.985","unit":"KGS","unitRateFc":"38","totalValueFC":"2876.8","currency":"USD","unitRateINR":"3237.6","date":"11-Nov-2024","totalValueINR":"242771.44","totalValueInUsd":"2876.8","indian_port":"JNPT","hs_no":"29223900","bill_no":"6612809","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"VIA PRIM?RIA 5-D QD 10 MOD.01 S\/N-D AIA ZIP CODE 75132-120 \/ AN?POLIS - GO - BRAZIL Brazil","customerAddress":"101,MEWAD,E S PATANWALA COMPLEX,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735842600,"product":"BUPROPION HYDROCHLORIDE USP CHEMICAL","address":"SECOND FLOOR, BLOCK-III,MY HOME HUB","city":"HYDERABAD, AP","supplier":"PHARMASPHERE COMPANY","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"GRANULES INDIA LIMITED","customerCountry":"INDIA","quantity":"4162.40","actualQuantity":"4162.4","unit":"KGS","unitRateFc":"63.9","totalValueFC":"266953.9","currency":"USD","unitRateINR":"5530.3","date":"03-Jan-2025","totalValueINR":"23019220.83","totalValueInUsd":"266953.9","indian_port":"Madras Sea","hs_no":"29223900","bill_no":"7595731","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"223 PERUVIAN AVENUE PALM BEACH, FL 33480 USA IT","customerAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHEMESS DWC LLC","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"909.20","actualQuantity":"909.2","unit":"KGS","unitRateFc":"136.1","totalValueFC":"125435.7","currency":"EUR","unitRateINR":"11950","date":"18-Mar-2025","totalValueINR":"10864940","totalValueInUsd":"125435.7","indian_port":"Bombay Air","hs_no":"29223900","bill_no":"8950210","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"POST BOX NO. 115710 806 MARINA RESIDENCE 3 PALM JUMEIRAH DUBAI AE","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"BUPROPION HYDROCHLORIDE","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DAHEJ","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"226.03","actualQuantity":"226.03","unit":"KGS","unitRateFc":"76.9","totalValueFC":"17546","currency":"USD","unitRateINR":"6645","date":"28-Apr-2025","totalValueINR":"1501969.35","totalValueInUsd":"17546","indian_port":"Dahez-SEZ","hs_no":"29223900","bill_no":"9750395","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DAHEJ","supplierAddress":"Plot No. Z\/15,Dahej SEZ Limited, P.O. Dahej Tal. Vagra, SDNF India","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
    05-Jan-2021
    28-Apr-2025
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    DRUG PRODUCT COMPOSITIONS

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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 - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **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**

    USFDA APPLICATION NUMBER - 18644

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

    USFDA APPLICATION NUMBER - 200063

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG

    USFDA APPLICATION NUMBER - 20358

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG

    USFDA APPLICATION NUMBER - 20358

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG

    USFDA APPLICATION NUMBER - 20358

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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**

    USFDA APPLICATION NUMBER - 20711

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG

    USFDA APPLICATION NUMBER - 21515

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG

    USFDA APPLICATION NUMBER - 21515

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 450M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 450MG

    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

    22

    PharmaCompass offers a list of Bupropion 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 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.

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

    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.

    Bupropion Hydrochloride Manufacturers

    A Bupropion Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupropion Hydrochloride, including repackagers and relabelers. The FDA regulates Bupropion Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupropion Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Bupropion Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Bupropion Hydrochloride Suppliers

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

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

    Bupropion Hydrochloride USDMF

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

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

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

    Bupropion Hydrochloride KDMF

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

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

    After submitting a Bupropion Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bupropion Hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

    Bupropion Hydrochloride WC

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

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

    Bupropion Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Bupropion Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Bupropion Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

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

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

    Bupropion Hydrochloride GMP

    Bupropion Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

    Bupropion Hydrochloride CoA

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

    Bupropion Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Bupropion Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

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