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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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14-Jan-2022
20-May-2025
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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

44

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 Hydrochloride Manufacturers

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

Amitriptyline Hydrochloride Suppliers

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

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

Amitriptyline Hydrochloride USDMF

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

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

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

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

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

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

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

Amitriptyline Hydrochloride CEP

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

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

Amitriptyline Hydrochloride WC

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

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

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

Finished drug products

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

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

Amitriptyline Hydrochloride GMP

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

Amitriptyline Hydrochloride CoA

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

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

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