List of Drug Master Files (DMF) of AMITRIPTYLINE HCL Active Pharmaceutical Ingredient listed on PharmaCompass.com

AMITRIPTYLINE HCL

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 14 USDMF, 9 CEP/COS, 2 JDMF, 7 EU WC, 3 KDMF, 19 NDC API, 13 Listed Suppliers, $ API Reference Price

27 API Suppliers
14 USDMF
9 CEP/COS
2 JDMF
7 EU WC
3 KDMF
19 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

376 FDF Dossiers, 288 FDA Orange Book, 16 Europe, 29 Canada, 4 South Africa, 39 Listed Dossiers

376 FDF Dossiers
288 FDA Orange Book
16 Europe
29 Canada
4 South Africa
39 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 10MG, TABLET;ORAL - 150MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, TABLET;ORAL - 75MG

drugProductComposition
TABLET;ORAL - 100MG
TABLET;ORAL - 10MG
TABLET;ORAL - 150MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
TABLET;ORAL - 75MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 13 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 35 Direct Compression, 32 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 25 Thickeners and Stabilizers, 24 Granulation, 24 Solubilizers, 16 Lubricants & Glidants, 16 Co-Processed Excipients, 15 Topical, 13 Parenteral, 11 Film Formers & Plasticizers, 9 Taste Masking, 8 Emulsifying Agents, 7 Rheology Modifiers, 7 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

10 NEWS #PharmaBuzz

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Finished Drug Prices

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1 US Medicaid Prescriptions
17 Finished Drug Prices

MARKET PLACE

12 APIs

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12 APIs

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 3 JP , 1 Others

otherSolutions
2 EDQM
1 USP
3 JP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 63

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

376

FDF Dossiers

288

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

80,576,804

Annual Reports (USD Million)

Finished Drug Prices

256 RELATED EXCIPIENT COMPANIES

426EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₂₀H₂₄ClN
Molecular Weight	313.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	3
Exact Mass	313.1597275 g/mol
Monoisotopic Mass	313.1597275 g/mol
Topological Polar Surface Area	3.2 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	331
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Amitriptyline hydrochloride
Drug Label	DESCRIPTIONAmitriptyline 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 Ingredient	Amitriptyline hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	75mg; 100mg; 25mg; 50mg; 10mg; 150mg
Market Status	Prescription
Company	Vintage Pharms; Mutual Pharm; Sun Pharm Inds; Sandoz; Mylan

2 of 2
Drug Name	Amitriptyline hydrochloride
Drug Label	DESCRIPTIONAmitriptyline 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 Ingredient	Amitriptyline hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	75mg; 100mg; 25mg; 50mg; 10mg; 150mg
Market Status	Prescription
Company	Vintage 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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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 100MG