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    Chemistry

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    Also known as: 549-18-8, Amitriptyline hcl, Annoyltin, Tryptizol, Domical, Syneudon
    Molecular Formula
    C20H24ClN
    Molecular Weight
    313.9  g/mol
    InChI Key
    KFYRPLNVJVHZGT-UHFFFAOYSA-N
    FDA UNII
    26LUD4JO9K
    Amitriptyline Hydrochloride
    Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
    1 2D Structure

    Amitriptyline Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C20H23N.ClH/c1-21(2)15-7-12-20-18-10-5-3-8-16(18)13-14-17-9-4-6-11-19(17)20;/h3-6,8-12H,7,13-15H2,1-2H3;1H
    2.1.3 InChI Key
    KFYRPLNVJVHZGT-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    26LUD4JO9K
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Amineurin

    2. Amitrip

    3. Amitriptylin Beta

    4. Amitriptylin Desitin

    5. Amitriptylin Neuraxpharm

    6. Amitriptylin Rph

    7. Amitriptylin-neuraxpharm

    8. Amitriptyline

    9. Amitrol

    10. Anapsique

    11. Apo Amitriptyline

    12. Apo-amitriptyline

    13. Damilen

    14. Desitin, Amitriptylin

    15. Domical

    16. Elavil

    17. Endep

    18. Laroxyl

    19. Lentizol

    20. Novoprotect

    21. Rph, Amitriptylin

    22. Saroten

    23. Sarotex

    24. Syneudon

    25. Triptafen

    26. Tryptanol

    27. Tryptine

    28. Tryptizol

    2.3.2 Depositor-Supplied Synonyms

    1. 549-18-8

    2. Amitriptyline Hcl

    3. Annoyltin

    4. Tryptizol

    5. Domical

    6. Syneudon

    7. Endep

    8. Lentizol

    9. Novoprotect

    10. Etravil

    11. Saroten

    12. Elavil Hydrochloride

    13. Amineurin

    14. Amitril

    15. Amitrip

    16. Anapsique

    17. Tryptine

    18. Amavil

    19. Amitid

    20. Ami-anelun

    21. Apo-amitriptyline

    22. Daprimen

    23. Elatrolet

    24. Maxivalet

    25. Miketorin

    26. Mitaptyline

    27. Rantoron

    28. Sarotena

    29. Trepiline

    30. Triptizol

    31. Trytomer

    32. Vanatrip

    33. Yamanouchi

    34. Amilit

    35. Amiplin

    36. Amiprin

    37. Amyline

    38. Amyzol

    39. Belpax

    40. Elatrol

    41. Enafon

    42. Etrafon

    43. Kyliran

    44. Larozyl

    45. Levate

    46. Pinsanu

    47. Pinsaun

    48. Teperin

    49. Triavil

    50. Tridep

    51. Tripta

    52. Trynol

    53. Damilen Hydrochloride

    54. Amitriptyline Chloride

    55. Saroten Retard

    56. Tryptizol Retard

    57. Limbitrol Ds

    58. Tryptacap Hydrochloride

    59. Adt-zimaia

    60. Oasil-m

    61. Redomex

    62. Proheptadien Monohydrochloride

    63. Amitriptyline (hydrochloride)

    64. Sk-amitriptyline Chloride

    65. Limbitrol

    66. Sarotex

    67. Nih 10794

    68. Ccris 7092

    69. Amitryptiline Hydrochloride

    70. Nsc-104210

    71. 26lud4jo9k

    72. Annolytin

    73. Mls000028437

    74. Component Of Etrafon

    75. Component Of Triavil

    76. 5-(3-(dimethylamino)propylidene) Dibenzosuberane Hcl

    77. 3-(10,11-dihydro-5h-dibenzo[a,d][7]annulen-5-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride

    78. 1-propanamine, 3-(10,11-dihydro-5h-dibenzo(a,d)cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride

    79. Novotriptyn

    80. Nornaln

    81. Smr000058368

    82. 549-18-8 (hcl)

    83. Amitryptyline Hydrochloride

    84. 5-(3-dimethylaminopropylidene)dibenzo(a,d)(1,4)cycloheptadiene Hydrochloride

    85. Dsstox_cid_13187

    86. Dsstox_rid_79055

    87. Dsstox_gsid_33187

    88. Amitriptyline Hydrochloride 100 Microg/ml In Acetonitrile

    89. 1-propanamine, 3-(10,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride

    90. 3-(10,11-dihydro-5h-dibenzo[a,d][7]annulen-5-ylidene)-n,n-dimethyl-1-propanamine Hydrochloride

    91. 3-(10,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethyl-1-propanamine Hydrochloride

    92. Nsc169910

    93. Wln: L C676 By&t&j Bu3n1&1 &gh

    94. Amitriptyline Hydrochloride [jan]

    95. Sr-01000003046

    96. Ncgc00015095-09

    97. Cas-549-18-8

    98. Einecs 208-964-6

    99. Mfcd00012537

    100. Amitryptylline Hydrochloride

    101. Unii-26lud4jo9k

    102. Nsc 104210

    103. Amilent

    104. Sylvemid

    105. Amicen

    106. Euplit

    107. Uxen

    108. 5-(3-dimethylaminopropylidene)dibenzo[a,4]cycloheptadiene Hydrochloride

    109. 5-[3-(dimethylamino)propylidene]dibenzo[a,4]cycloheptadiene Hydrochloride

    110. 1-propanamine,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride

    111. 5-(3-dimethylaminopropylidene)dibenzo[a,d][1,4]cycloheptadiene Hydrochloride

    112. 5h-dibenzo[a,.gamma.-propylamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride

    113. 5h-dibenzo[a,.gamma.-propylamine, 10,11-dihydro-n,n-dimethyl-,hydrochloride

    114. Prestwick_20

    115. 3-(5,6-dihydrodibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-n,n-dimethylpropan-1-amine;hydrochloride

    116. Drg-0169

    117. Elavil (tn)

    118. Amitriptyline Hydrochloride [usp:jan]

    119. Cpd000058368

    120. Opera_id_618

    121. Nortriptyline Impurity F

    122. Amitriptylini Hydrochloridum

    123. C20h23n.hcl

    124. Schembl41079

    125. 10,11-dihydro-n,n-dimethyl-5h-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine Hydrochloride

    126. Mls001055393

    127. Mls001074176

    128. Mls002222152

    129. Spectrum1500117

    130. Regid_for_cid_11065

    131. Chebi:2667

    132. Chembl1200964

    133. Dtxsid9033187

    134. Hy-b0527a

    135. Amitriptyline Hydrochloride ,(s)

    136. Amitriptyline Hydrochloride, 99%

    137. Hms1568o09

    138. Hms1920c13

    139. Pharmakon1600-01500117

    140. Bcp31573

    141. Amitriptyline-[13c3] Hydrochloride

    142. Tox21_113122

    143. Tox21_201278

    144. Tox21_303612

    145. Tox21_500112

    146. Ccg-38919

    147. Nsc104210

    148. Nsc755869

    149. S3183

    150. Akos015994716

    151. Tox21_113122_1

    152. Ks-1291

    153. Lp00112

    154. Nc00497

    155. Nsc-169910

    156. Nsc-755869

    157. Amitriptyline Hydrochloride (jp17/usp)

    158. Amitriptyline Hydrochloride [mi]

    159. Ncgc00015095-15

    160. Ncgc00024433-03

    161. Ncgc00024433-05

    162. Ncgc00093609-01

    163. Ncgc00093609-02

    164. Ncgc00093609-03

    165. Ncgc00093609-04

    166. Ncgc00093609-05

    167. Ncgc00257393-01

    168. Ncgc00258830-01

    169. Ncgc00260797-01

    170. 5h-dibenzo(a,d)cycloheptene-delta(sup 5),gamma-propylamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride

    171. 5h-dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride

    172. Amitriptyline Hydrochloride [hsdb]

    173. Ba164159

    174. N,n-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine;hydrochloride

    175. Amitriptyline Hcl;nortriptyline Impurity F

    176. Amitriptyline Hydrochloride [mart.]

    177. Amitriptyline Hydrochloride [vandf]

    178. Amitriptyline Hydrochloride [usp-rs]

    179. Amitriptyline Hydrochloride [who-dd]

    180. Amitriptyline Hydrochloride [who-ip]

    181. A0908

    182. Eu-0100112

    183. Ft-0662108

    184. Ft-0662109

    185. Sw196337-3

    186. A 8404

    187. A16404

    188. D00809

    189. D81789

    190. Amitriptyline Hydrochloride [ep Impurity]

    191. A854879

    192. Amitriptyline Hydrochloride [ep Monograph]

    193. Amitriptyline Hydrochloride [usp Impurity]

    194. Amitriptyline Hydrochloride [usp Monograph]

    195. Amitriptylini Hydrochloridum [who-ip Latin]

    196. Amitriptyline Hydrochloride, >=98% (tlc), Powder

    197. Sr-01000003046-2

    198. Sr-01000003046-6

    199. W-105596

    200. Etrafon-a Component Amitriptyline Hydrochloride

    201. Limbitrol Component Amitriptyline Hydrochloride

    202. Q27254112

    203. Amitriptyline Hydrochloride Component Of Etrafon-a

    204. Amitriptyline Hydrochloride Component Of Limbitrol

    205. F0001-1443

    206. Limbitrol Ds Component Amitriptyline Hydrochloride

    207. Amitriptyline Hydrochloride Component Of Limbitrol Ds

    208. 5-[3-(dimethylamino)propylidene]dibenzosuberane Hydrochloride

    209. Amitriptyline Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    210. Amitriptyline Hydrochloride, Drug Standard, 1.0 Mg/ml In Methanol

    211. Amitriptyline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    212. Amitriptyline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    213. Amitriptyline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    214. Amitriptyline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    215. 1-propanamine, 3-(10,11-dihydro-5h-dibenzo(a,d)cyclohepten-5-ylidene)-n,n-dimethyl-, Hydrochloride (1:1)

    216. 10,11-dihydro-n,n-dimethyl-5h-dibenzo[a,d]cycloheptene-delta5,gamma-propylamine Hydrochloride

    217. 3-(10,11-dihydro-5h-dibenzo[a,d]cyc Lohepten-5-ylidene)-n,n-dimethyl-1-propanamine Hydrochloride

    218. 5h-dibenzo[a,d]cycloheptene-delta(sup5),gamma-propylamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride

    219. 5h-dibenzo[a,d]cycloheptene-delta5,gamma-propylamine, 10,11-dihydro-n,n-dimethyl-, Hydrochloride (6ci,8ci)

    220. Amitriptyline Hydrochloride Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    221. N,n-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine;hydron;chloride

    2.4 Create Date
    2005-06-08
    3 Chemical and Physical Properties
    Molecular Weight 313.9 g/mol
    Molecular Formula C20H24ClN
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count3
    Exact Mass313.1597275 g/mol
    Monoisotopic Mass313.1597275 g/mol
    Topological Polar Surface Area3.2 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity331
    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 2  
    Drug NameAmitriptyline hydrochloride
    Drug LabelDESCRIPTIONAmitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula isAmitriptyline HCl, a dibenzocycloheptadiene deriv...
    Active IngredientAmitriptyline hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength75mg; 100mg; 25mg; 50mg; 10mg; 150mg
    Market StatusPrescription
    CompanyVintage Pharms; Mutual Pharm; Sun Pharm Inds; Sandoz; Mylan

    2 of 2  
    Drug NameAmitriptyline hydrochloride
    Drug LabelDESCRIPTIONAmitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula isAmitriptyline HCl, a dibenzocycloheptadiene deriv...
    Active IngredientAmitriptyline hydrochloride
    Dosage FormTablet
    Routeoral; Oral
    Strength75mg; 100mg; 25mg; 50mg; 10mg; 150mg
    Market StatusPrescription
    CompanyVintage Pharms; Mutual Pharm; Sun Pharm Inds; Sandoz; Mylan

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Analgesics, Non-Narcotic

    A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)

    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.)

    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.)

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

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","customerCountry":"BRAZIL","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"45","totalValueFC":"4419.1","currency":"USD","unitRateINR":3843,"date":"04-Feb-2025","totalValueINR":"384300","totalValueInUsd":"4419.1","indian_port":"Hyderabad ICD","hs_no":"29420025","bill_no":"7883358","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"78\/A,VENGALARAO NAGAR, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738693800,"product":"AMITRIPTYLINE HYDROCHLORIDE CONTROL BATCH NO 2020900123 MFG DT. 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DIARY","city":"BANGALORE,KARNATAKA","supplier":"R L FINE CHEM","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"40","totalValueFC":"3702.2","currency":"USD","unitRateINR":3219.5799999999999,"date":"06-Feb-2025","totalValueINR":"321958","totalValueInUsd":"3702.2","indian_port":"Bangalore Air","hs_no":"29420025","bill_no":"7934131","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"RAY HOUSE, HIG 2000,,MOTHER DIARY, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739212200,"product":"PHARMACEUTICAL BULK DRUG-AMITRIPTYLINE HYDROCHLORIDE\/EP (BATCH NO AMT\/225024)","address":"RAY HOUSE, HIG 2000,,MOTHER DIARY","city":"BANGALORE,KARNATAKA","supplier":"R L FINE 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CHEM","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO EASTERN BANK PLC","customerCountry":"BANGLADESH","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"30.5","totalValueFC":"17382.5","currency":"USD","unitRateINR":2519.4250000000002,"date":"27-Feb-2025","totalValueINR":"1511655","totalValueInUsd":"17382.5","indian_port":"Hyderabad Air","hs_no":"29420025","bill_no":"8536915","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"78\/A,VENGALARAO NAGAR, ANDHRA PRADESH","customerAddress":""}]
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 100MG

    USFDA APPLICATION NUMBER - 85968

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 85968

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    DOSAGE - TABLET;ORAL - 150MG

    USFDA APPLICATION NUMBER - 85968

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 85968

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 85968

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    DOSAGE - TABLET;ORAL - 75MG

    USFDA APPLICATION NUMBER - 85968

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    ABOUT THIS PAGE

    Looking for 549-18-8 / Amitriptyline Hydrochloride API manufacturers, exporters & distributors?

    Amitriptyline Hydrochloride manufacturers, exporters & distributors 1

    64

    PharmaCompass offers a list of Amitriptyline 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 Amitriptyline Hydrochloride manufacturer or Amitriptyline Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Amitriptyline Hydrochloride

    Synonyms

    549-18-8, Amitriptyline hcl, Annoyltin, Tryptizol, Domical, Syneudon

    Cas Number

    549-18-8

    Unique Ingredient Identifier (UNII)

    26LUD4JO9K

    About Amitriptyline Hydrochloride

    Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.

    AMITRIPTYLINE HCL Manufacturers

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

    AMITRIPTYLINE HCL Suppliers

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

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

    AMITRIPTYLINE HCL USDMF

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

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

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

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

    AMITRIPTYLINE HCL KDMF

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

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

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

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

    AMITRIPTYLINE HCL CEP

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

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

    AMITRIPTYLINE HCL WC

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

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

    AMITRIPTYLINE HCL 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 AMITRIPTYLINE HCL as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    AMITRIPTYLINE HCL GMP

    AMITRIPTYLINE HCL 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 AMITRIPTYLINE HCL 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 AMITRIPTYLINE HCL GMP manufacturer or AMITRIPTYLINE HCL GMP API supplier for your needs.

    AMITRIPTYLINE HCL CoA

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

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

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