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    Chemistry

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    Also known as: 113-52-0, Imipramine hcl, Tofranil, Pryleugan, Imizine, Chimoreptin
    Molecular Formula
    C19H25ClN2
    Molecular Weight
    316.9  g/mol
    InChI Key
    XZZXIYZZBJDEEP-UHFFFAOYSA-N
    FDA UNII
    BKE5Q1J60U
    Imipramine Hydrochloride
    The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.
    1 2D Structure

    Imipramine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-(5,6-dihydrobenzo[b][1]benzazepin-11-yl)-N,N-dimethylpropan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H24N2.ClH/c1-20(2)14-7-15-21-18-10-5-3-8-16(18)12-13-17-9-4-6-11-19(17)21;/h3-6,8-11H,7,12-15H2,1-2H3;1H
    2.1.3 InChI Key
    XZZXIYZZBJDEEP-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)CCCN1C2=CC=CC=C2CCC3=CC=CC=C31.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    BKE5Q1J60U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4,4'-methylenebis(3-hydroxy-2-naphthoic Acid)-3-(10,11-dihydro-5h-dibenzo(b,f)azepin-5-yl)-n,n-dimethyl-1-propanamine (1:2)

    2. Imidobenzyle

    3. Imipramine

    4. Imipramine Monohydrochloride

    5. Imipramine Pamoate

    6. Imizin

    7. Janimine

    8. Melipramine

    9. Norchlorimipramine

    10. Pryleugan

    11. Tofranil

    2.3.2 Depositor-Supplied Synonyms

    1. 113-52-0

    2. Imipramine Hcl

    3. Tofranil

    4. Pryleugan

    5. Imizine

    6. Chimoreptin

    7. Chrytemin

    8. Presamine

    9. Feinalmin

    10. Imilanyle

    11. Persamine

    12. Pertofram

    13. Teperine

    14. Tofranile

    15. Iprogen

    16. Janimine

    17. Pramine

    18. Imp Hydrochloride

    19. Ia-pram

    20. Imizin

    21. Co Cap Imipramine 25

    22. Melipramine Hcl

    23. Antideprin Hydrochloride

    24. Imipramini Hydrochloridum

    25. Imipramine Monohydrochloride

    26. Imizinum

    27. Imidol

    28. Imipramine (hydrochloride)

    29. G 22355

    30. 3-(5,6-dihydrobenzo[b][1]benzazepin-11-yl)-n,n-dimethylpropan-1-amine;hydrochloride

    31. Nsc-114900

    32. N-(3-dimethylaminopropyl)iminodibenzyl Hydrochloride

    33. Bke5q1j60u

    34. Mls000028430

    35. Chebi:5882

    36. Deprinol

    37. 3-(10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine Hydrochloride

    38. 5-(3-(dimethylamino)propyl)-10,11-dihydro-5h-dibenz(b,f)azepine Monohydrochloride

    39. 5h-dibenz(b,f)azepine-5-propanamine, 10,11-dihydro-n,n-dimethyl-, Monohydrochloride

    40. Sk-pramine

    41. Psicopramine

    42. Thymopramin

    43. Dynazina

    44. Efuranol

    45. Fujisawa

    46. Imipramini

    47. Odeoxil

    48. Smr000058388

    49. Tipramine

    50. Venefon

    51. Vionyl

    52. Tofranil (tn)

    53. 5h-dibenz[b,f]azepine-5-propanamine, 10,11-dihydro-n,n-dimethyl-, Monohydrochloride

    54. G-22355

    55. Imipram

    56. Sk-pramine Hydrochloride

    57. Imipramine Hydrochloride [jan]

    58. Melipramine Hydrochloride

    59. Sr-01000003064

    60. Cas-113-52-0

    61. Einecs 204-030-7

    62. Mfcd00012669

    63. Unii-bke5q1j60u

    64. Nsc 114900

    65. Imipraminehcl

    66. Sk-pramine Hcl

    67. Prestwick_277

    68. Imipramine Hydrochloride [usp:jan]

    69. Nebumetone Impurity D

    70. N-(gamma-dimethylaminopropyl)iminodibenzyl Hydrochloride

    71. 3-(5,6-dihydrobenzo[b][1]benzazepin-11-yl)-n,n-dimethyl-propan-1-amine

    72. Cpd000058388

    73. Opera_id_319

    74. N-(gamma-dimetilaminopropil)-iminodibenzile Cloridrato [italian]

    75. Surecn41766

    76. Imipramine Hydrochloride Rs

    77. 5-(3-dimethylaminopropyl)-10,11-dihydro-5h-dibenz(b,f)azepine Hydrochloride

    78. 5h-dibenz(b,f)azepine, 10,11-dihydro-5-(3-(dimethylamino)propyl)-, Hydrochloride

    79. Chembl1692

    80. Dsstox_cid_20738

    81. Dsstox_rid_79581

    82. Dsstox_gsid_40738

    83. G 22150

    84. Regid_for_cid_8228

    85. Schembl41765

    86. Mls001146891

    87. Mls002222195

    88. Spectrum1500348

    89. N-(gamma-dimetilaminopropil)-iminodibenzile Cloridrato

    90. Dtxsid7040738

    91. Imipramine For System Suitability

    92. Hms1568o05

    93. Hms1920f17

    94. Pharmakon1600-01500348

    95. Hy-b1490

    96. Tox21_301417

    97. Tox21_500702

    98. Ccg-40208

    99. Imipramine Hydrochloride [mi]

    100. Nsc114900

    101. Nsc757074

    102. S4377

    103. Imipramine Hydrochloride (jp17/usp)

    104. Akos015895330

    105. Ac-7587

    106. Cs-6180

    107. Ks-1072

    108. Lp00702

    109. Nc00570

    110. Nsc-757074

    111. 5h-dibenz(b,f)azepine, 5-(3-(dimethylamino)propyl)-10,11-dihydro-, Monohydrochloride

    112. Imipramine Hydrochloride [mart.]

    113. Imipramine Hydrochloride [vandf]

    114. Imipramine Hydrochloride [usp-rs]

    115. Imipramine Hydrochloride [who-dd]

    116. Imipramine Hydrochloride [who-ip]

    117. Ncgc00024253-05

    118. Ncgc00094054-01

    119. Ncgc00094054-02

    120. Ncgc00094054-03

    121. Ncgc00094054-04

    122. Ncgc00094054-05

    123. Ncgc00255651-01

    124. Ncgc00261387-01

    125. (3-{2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaen-2-yl}propyl)dimethylamine Hydrochloride

    126. Bi164574

    127. Imipramine Hydrochloride, >=99% (tlc)

    128. Db-041172

    129. Eu-0100702

    130. Ft-0631652

    131. Ft-0670318

    132. I0971

    133. St50985122

    134. Sw196582-4

    135. Imipramine Hydrochloride [orange Book]

    136. C07982

    137. D00815

    138. I 7379

    139. Imipramine Hydrochloride [ep Monograph]

    140. Imipramine Hydrochloride [usp Impurity]

    141. Imipramine Hydrochloride [usp Monograph]

    142. Imipramini Hydrochloridum [who-ip Latin]

    143. 113i520

    144. Imipramine Hydrochloride, Bioxtra, >=99% (tlc)

    145. Imipramine Hydrochloride, Sigma Reference Standard

    146. J-002975

    147. Lmipramine Hydrochloride 100 Microg/ml In Methanol

    148. Q-200878

    149. Sr-01000003064-2

    150. Sr-01000003064-7

    151. 5-(3-dimethylaminopropyl)-10,f)azepine Hydrochloride

    152. Q27106923

    153. Wln: T C676 Bn & T & J B3n1 & 1 & Gh

    154. Z1551429721

    155. N-(.gamma.-dimethylaminopropyl)iminodibenzyl Hydrochloride

    156. 5h-dibenz[b, 10,11-dihydro-n,n-dimethyl-, Monohydrochloride

    157. Imipramine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    158. 5h-dibenz[b, 10,11-dihydro-5-[3-(dimethylamino)propyl]-, Hydrochloride

    159. Imipramine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    160. 10,11-dihydro-n,n-dimethyl-5h-dibenzo[b,f]azepine-5-propanamine Hydrochloride

    161. 5-(3-dimethylaminopropyl)-10,11-dihydro-5h-dibenz-[b,f]-azepine, Hydrochloride

    162. 5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenzo[b,f]azepine Hydrochloride

    163. 5h-dibenz(b,f)azepine-5-propanamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride (1:1)

    164. 5h-dibenz[b, 5-[3-(dimethylamino)propyl]-10,11-dihydro-, Monohydrochloride

    165. Imipramine For System Suitability, European Pharmacopoeia (ep) Reference Standard

    166. Imipramine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    167. Imipramine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    168. (3-{2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-yl}propyl)dimethylamine Hydrochloride

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

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 316.9 g/mol
    Molecular Formula C19H25ClN2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count4
    Exact Mass316.1706265 g/mol
    Monoisotopic Mass316.1706265 g/mol
    Topological Polar Surface Area6.5 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity291
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameImipramine hydrochloride
    PubMed HealthImipramine (By mouth)
    Drug ClassesAntidepressant, Urinary Enuresis Agent
    Drug LabelImipramine hydrochloride, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-[3-(Dimethylamino) propyl]-10, 11-dihydro-5H-dibenz [b,f]-azepine monohydrochloride. Structurally, it may be repr...
    Active IngredientImipramine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 50mg; 10mg
    Market StatusPrescription
    CompanyExcellium; Lupin; Sandoz; Par Pharm; Mutual Pharm

    2 of 4  
    Drug NameTofranil
    Drug LabelTofranil is supplied in tablet form for oral administration.Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-3-(dimethylamino)propyl-10,11-dihydr...
    Active IngredientImipramine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 50mg; 10mg
    Market StatusPrescription
    CompanyMallinckrodt

    3 of 4  
    Drug NameImipramine hydrochloride
    PubMed HealthImipramine (By mouth)
    Drug ClassesAntidepressant, Urinary Enuresis Agent
    Drug LabelImipramine hydrochloride, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-[3-(Dimethylamino) propyl]-10, 11-dihydro-5H-dibenz [b,f]-azepine monohydrochloride. Structurally, it may be repr...
    Active IngredientImipramine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 50mg; 10mg
    Market StatusPrescription
    CompanyExcellium; Lupin; Sandoz; Par Pharm; Mutual Pharm

    4 of 4  
    Drug NameTofranil
    Drug LabelTofranil is supplied in tablet form for oral administration.Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-3-(dimethylamino)propyl-10,11-dihydr...
    Active IngredientImipramine hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 50mg; 10mg
    Market StatusPrescription
    CompanyMallinckrodt

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic Uptake Inhibitors

    Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)

    Antidepressive Agents, Tricyclic

    Substances that contain a fused three-ring moiety and are used in the treatment of depression. These drugs block the uptake of norepinephrine and serotonin into axon terminals and may block some subtypes of serotonin, adrenergic, and histamine receptors. However, the mechanism of their antidepressant effects is not clear because the therapeutic effects usually take weeks to develop and may reflect compensatory changes in the central nervous system. (See all compounds classified as Antidepressive Agents, Tricyclic.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Tricyclic Antidepressant [EPC]

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APRIL 2028","address":"M-34, SAKET,","city":"NEW DELHI,DELHI","supplier":"TEVA API","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. 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LTDA","customerCountry":"BRAZIL","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"299.5","totalValueFC":"11539.7","currency":"USD","unitRateINR":24175.938249999999,"date":"28-Sep-2024","totalValueINR":"967037.53","totalValueInUsd":"11539.7","indian_port":"Dadri-CGML","hs_no":"29333990","bill_no":"4422403","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Dadri-CGML","supplierAddress":"M-34, SAKET,, NEW DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"IMIPRAMINE HYDROCHLORIDE - CATALOG- 70402001 CONTROL NO.2001902023 MFG DT.MAY2023 RETEST .MAY - 2025","address":"M-34, SAKET,","city":"NEW DELHI,DELHI","supplier":"TEVA API","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"CRISTALIA PRODUTOS QUIMICOS FARMA. LTDA","customerCountry":"BRAZIL","quantity":"25.89","actualQuantity":"25.89","unit":"KGS","unitRateFc":"299.5","totalValueFC":"7469","currency":"USD","unitRateINR":24175.905368868287,"date":"28-Sep-2024","totalValueINR":"625914.19","totalValueInUsd":"7469","indian_port":"Dadri-CGML","hs_no":"29333990","bill_no":"4422403","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Dadri-CGML","supplierAddress":"M-34, SAKET,, NEW DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"IMIPRAMINE HYDROCHLORIDE - CATALOG- 70402001 CONTROL NO.2001902123 MFG DT.MAY 2023 RETEST .MAY - 2025","address":"M-34, SAKET,","city":"NEW DELHI,DELHI","supplier":"TEVA API","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"CRISTALIA PRODUTOS QUIMICOS FARMA. LTDA","customerCountry":"BRAZIL","quantity":"429.75","actualQuantity":"429.75","unit":"KGS","unitRateFc":"299.5","totalValueFC":"123979.1","currency":"USD","unitRateINR":24175.923885980217,"date":"28-Sep-2024","totalValueINR":"10389603.29","totalValueInUsd":"123979.1","indian_port":"Dadri-CGML","hs_no":"29333990","bill_no":"4422403","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Dadri-CGML","supplierAddress":"M-34, SAKET,, NEW DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"IMIPRAMINE HYDROCHLORIDE USP42. (TAX INVOICE NO:162 DT:16.10.2024)","address":"36\/A, VENGAL RAO NAGAR","city":"HYDERABAD","supplier":"HARIKA DRUGS","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"GOODMAN CHEMICALS CO. ","customerCountry":"THAILAND","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"91","totalValueFC":"4370","currency":"USD","unitRateINR":7343.8599999999997,"date":"25-Oct-2024","totalValueINR":"367193","totalValueInUsd":"4370","indian_port":"Hyderabad Air","hs_no":"29420024","bill_no":"5146340","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"36\/A, VENGAL RAO NAGAR, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:DOM0253 DT:15.10.2024) IMIPRAMINE HYDROCHLORIDE USP","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"90","totalValueFC":"8911.5","currency":"USD","unitRateINR":7487.9994999999999,"date":"28-Oct-2024","totalValueINR":"748799.95","totalValueInUsd":"8911.5","indian_port":"Bombay Air","hs_no":"29420024","bill_no":"5192827","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:DOM0249 DT:14.10.2024) IMIPRAMINE HYDROCHLORIDE USP","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"VIRACOPOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"87","totalValueFC":"8603.3","currency":"USD","unitRateINR":7260.1503000000002,"date":"11-Nov-2024","totalValueINR":"726015.03","totalValueInUsd":"8603.3","indian_port":"Bombay Air","hs_no":"29420024","bill_no":"5497839","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"PHARMACEUTICAL BULK DRUG IMIPRAMINE HYDROCHLORIDE\/JP BATCH NO:IMP\/224012,IMP\/224011,IMP\/224013","address":"RAY HOUSE, HIG 2000,,MOTHER DIARY","city":"BANGALORE,KARNATAKA","supplier":"R L FINE CHEM","supplierCountry":"INDIA","foreign_port":"OSAKA","customer":"TO THE ORDER OF","customerCountry":"JAPAN","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"215","totalValueFC":"31608.7","currency":"USD","unitRateINR":17782.682799999999,"date":"11-Nov-2024","totalValueINR":"2667402.42","totalValueInUsd":"31608.7","indian_port":"Bangalore Air","hs_no":"29420024","bill_no":"5505790","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"RAY HOUSE, HIG 2000,,MOTHER DIARY, BANGALORE,KARNATAKA","customerAddress":""}]
    26-Feb-2021
    11-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 87846

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 87846

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 87846

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    USP

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    ABOUT THIS PAGE

    Imipramine Hydrochloride Manufacturers

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

    Imipramine Hydrochloride Suppliers

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

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

    Imipramine Hydrochloride USDMF

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

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

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

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

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

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

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

    Imipramine Hydrochloride CEP

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

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

    Imipramine Hydrochloride WC

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

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

    Imipramine 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 Imipramine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Imipramine Hydrochloride GMP

    Imipramine 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 Imipramine 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 Imipramine Hydrochloride GMP manufacturer or Imipramine Hydrochloride GMP API supplier for your needs.

    Imipramine Hydrochloride CoA

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

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

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