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Chemistry

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Also known as: 298-46-4, Tegretol, Carbamazepen, Finlepsin, Biston, 5h-dibenzo[b,f]azepine-5-carboxamide
Molecular Formula
C15H12N2O
Molecular Weight
236.27  g/mol
InChI Key
FFGPTBGBLSHEPO-UHFFFAOYSA-N
FDA UNII
33CM23913M

Carbamazepine
A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.
Carbamazepine is a Mood Stabilizer. The mechanism of action of carbamazepine is as a Cytochrome P450 3A4 Inducer, and Cytochrome P450 1A2 Inducer, and Cytochrome P450 2B6 Inducer, and Cytochrome P450 2C9 Inducer, and Cytochrome P450 2C19 Inducer. The physiologic effect of carbamazepine is by means of Decreased Central Nervous System Disorganized Electrical Activity.
1 2D Structure

Carbamazepine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
benzo[b][1]benzazepine-11-carboxamide
2.1.2 InChI
InChI=1S/C15H12N2O/c16-15(18)17-13-7-3-1-5-11(13)9-10-12-6-2-4-8-14(12)17/h1-10H,(H2,16,18)
2.1.3 InChI Key
FFGPTBGBLSHEPO-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C2C(=C1)C=CC3=CC=CC=C3N2C(=O)N
2.2 Other Identifiers
2.2.1 UNII
33CM23913M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Amizepine

2. Carbamazepine Acetate

3. Carbamazepine Anhydrous

4. Carbamazepine Dihydrate

5. Carbamazepine Hydrochloride

6. Carbamazepine L-tartrate (4:1)

7. Carbamazepine Phosphate

8. Carbamazepine Sulfate (2:1)

9. Carbazepin

10. Epitol

11. Finlepsin

12. Neurotol

13. Tegretol

2.3.2 Depositor-Supplied Synonyms

1. 298-46-4

2. Tegretol

3. Carbamazepen

4. Finlepsin

5. Biston

6. 5h-dibenzo[b,f]azepine-5-carboxamide

7. Equetro

8. Tegretal

9. 5h-dibenz[b,f]azepine-5-carboxamide

10. Carbazepine

11. Neurotol

12. Epitol

13. Timonil

14. Carbamezepine

15. Carbatrol

16. Karbamazepin

17. Stazepine

18. Telesmin

19. Lexin

20. Tegretol-xr

21. Benzo[b][1]benzazepine-11-carboxamide

22. Carbamazepin

23. Carbamazepinum

24. Teril

25. Geigy 32883

26. 5h-dibenz(b,f)azepine-5-carboxamide

27. Carbamazepina

28. Amizepin

29. Bipotrol

30. Carnexiv

31. Sirtal

32. 5-carbamyl-5h-dibenzo(b,f)azepine

33. 5-carbamoyl-5h-dibenzo(b,f)azepine

34. Calepsin

35. Carbamazepine Anhydrous

36. 5-carbamoyl-5h-dibenz(b,f)azepine

37. 5-carbamoyl-5h-dibenz[b,f]azepine

38. G-32883

39. G 32883

40. Karbelex

41. Neurotop

42. Nsc 169864

43. Mfcd00005073

44. Chebi:3387

45. Chembl108

46. Nsc-169864

47. Carbamazepine Extended Release

48. 5-carbamyldibenzo(b,f)azepine

49. Mls000069652

50. 5-carbamoyldibenzo(b,f)azepine

51. Cbz

52. Nsc169864

53. 33cm23913m

54. Ncgc00015234-11

55. Cas-298-46-4

56. Smr000058201

57. Stazepin

58. Dsstox_cid_2731

59. 2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene-2-carboxamide

60. Dsstox_rid_76704

61. Dsstox_gsid_22731

62. 5h-dibenzo[b,f]azepine-5-carboxamide;oxcarbazepine Impurity A

63. Carbelan

64. Tegretol Cr

65. Carbamazepinum [inn-latin]

66. Carbamazepina [inn-spanish]

67. Smr001227191

68. Hsdb 3019

69. Sr-01000000229

70. Carbatrol Extended-release

71. Einecs 206-062-7

72. Brn 1246090

73. Trimonil

74. Neurotop Retard

75. Unii-33cm23913m

76. Dibenzo[b,f]azepine-5-carboxamide

77. Tegretol (tn)

78. Prestwick_104

79. Equetro (tn)

80. Carbamazepine-[d2]

81. Carbamazepine, Powder

82. Opera_id_72

83. Spectrum_000096

84. Carbamazepine [usan:usp:inn:ban:jan]

85. Prestwick0_000052

86. Prestwick1_000052

87. Prestwick2_000052

88. Prestwick3_000052

89. Spectrum2_000125

90. Spectrum3_000325

91. Spectrum4_000262

92. Spectrum5_000936

93. Carbamazepine (carbatrol)

94. Lopac-c-4024

95. Chemdiv1_018966

96. Carbamazepine [mi]

97. Cbchromo1_000350

98. Epitope Id:174842

99. Iminostilbene-n-carboxamide

100. Carbamazepine [inn]

101. Carbamazepine [jan]

102. Carbamazepine [hsdb]

103. Carbamazepine [usan]

104. Carbamazepine-[13c,15n]

105. Lopac0_000292

106. Oprea1_790775

107. Schembl21639

108. Bspbio_000203

109. Bspbio_001929

110. Carbamazepine [vandf]

111. Kbiogr_000724

112. Kbioss_000516

113. Mls001055475

114. Mls001074172

115. Mls002548877

116. Bidd:gt0479

117. Carbamazepine [mart.]

118. Divk1c_000388

119. Divk1c_003750

120. Spectrum1500159

121. Spbio_000170

122. Spbio_002124

123. Carbamazepine [usp-rs]

124. Carbamazepine [who-dd]

125. Carbamazepine [who-ip]

126. Bpbio1_000225

127. Gtpl5339

128. Zinc4785

129. Dtxsid4022731

130. Schembl19838283

131. Hms501d10

132. Hms640o02

133. Kbio1_000388

134. Kbio2_000516

135. Kbio2_003084

136. Kbio2_005652

137. Kbio3_001149

138. Wln: T C676 Bnj Bvz

139. Carbamazepine (jp17/usp/inn)

140. Cbz;nsc 169864

141. Spd-417

142. Carbamazepine, Analytical Standard

143. Ninds_000388

144. Hms1568k05

145. Hms1920i17

146. Hms2090m07

147. Hms2091o19

148. Hms2095k05

149. Hms2233g16

150. Hms3039k09

151. Hms3259b21

152. Hms3260l06

153. Hms3372j13

154. Hms3657g03

155. Hms3712k05

156. Hms3747e03

157. Pharmakon1600-01500159

158. Carbamazepine [orange Book]

159. Act02606

160. Bcp21380

161. Hy-b0246

162. 5-carbomoyl-5h-dibenzo(b,f)azepine

163. Carbamazepine [ep Monograph]

164. Carbamazepine [usp Impurity]

165. Tox21_110104

166. Tox21_202273

167. Tox21_300195

168. Tox21_500292

169. Ac2074

170. Bdbm50003659

171. Carbamazepine [usp Monograph]

172. Ccg-38931

173. Nsc755920

174. S1693

175. Stk177357

176. Stl453548

177. 11-benzo[b][1]benzazepinecarboxamide

178. 5h-dibenz[b,f]azepine-5-carboxamine

179. Carbamazepine 1.0 Mg/ml In Methanol

180. Carbamazepinum [who-ip Latin]

181. Akos003235644

182. Akos025397243

183. Tox21_110104_1

184. Ac-9538

185. Db00564

186. Ks-5146

187. Lp00292

188. Nc00679

189. Nsc-755920

190. Sdccgsbi-0050280.p005

191. 5h-dibenz[ B, F]azepine-5-carboxamide

192. Carbamazepin 100 Microg/ml In Methanol

193. Cds1_002710

194. Idi1_000388

195. 5h-dibenzo[b,f]azepine-5-carboxamide #

196. Ncgc00015234-01

197. Ncgc00015234-02

198. Ncgc00015234-03

199. Ncgc00015234-04

200. Ncgc00015234-05

201. Ncgc00015234-06

202. Ncgc00015234-07

203. Ncgc00015234-08

204. Ncgc00015234-09

205. Ncgc00015234-10

206. Ncgc00015234-12

207. Ncgc00015234-13

208. Ncgc00015234-14

209. Ncgc00015234-15

210. Ncgc00015234-16

211. Ncgc00015234-18

212. Ncgc00015234-19

213. Ncgc00015234-33

214. Ncgc00023877-03

215. Ncgc00023877-04

216. Ncgc00023877-05

217. Ncgc00023877-06

218. Ncgc00023877-07

219. Ncgc00023877-08

220. Ncgc00253982-01

221. Ncgc00259822-01

222. Ncgc00260977-01

223. Bc166161

224. Sy002823

225. (z)-5h-dibenzo[b,f]azepine-5-carboxamide

226. Sbi-0050280.p004

227. 5h-dibenzo[b,f]azepine-5-carboximidic Acid

228. Db-047659

229. Dibenzo[b,f]azepine-5-carboxylic Acid Amide

230. Eu-0100292

231. Ft-0602927

232. Ft-0696814

233. Sw220141-1

234. Oxcarbazepine Impurity A [ep Impurity]

235. Bim-0050280.0001

236. C 4024

237. C06868

238. Carbamazepine, Meets Usp Testing Specifications

239. D00252

240. 5h-dibenz(b,f)azepine-5-carboxamide Maleic Acid

241. 5h-dibenz(b,f)azepine-5-carboxamide Oxalic Acid

242. Ab00051931-17

243. Ab00051931-18

244. Ab00051931_19

245. Ab00051931_20

246. A820074

247. Q410412

248. Carbamazepine Host Structure With Maleic Acid Removed

249. Carbamazepine Host Structure With Oxalic Acid Removed

250. Q-200792

251. Sr-01000000229-2

252. Sr-01000000229-4

253. Sr-01000000229-7

254. 5h-dibenz(b,f)azepine-5-carboxamide Dl-tartaric Acid

255. Brd-k71799949-001-06-7

256. F0348-2551

257. Z2199879032

258. Carbamazepine Host Structure With Dl-tartaric Acid Removed

259. Dibenzo[b,f]azepine-5-carboxylic Acid Amide(carbamazepine)

260. Carbamazepine Host Structure With 4-hydroxybenzoic Acid Removed

261. Carbamazepine, British Pharmacopoeia (bp) Reference Standard

262. Carbamazepine, European Pharmacopoeia (ep) Reference Standard

263. Carbamazepine, United States Pharmacopeia (usp) Reference Standard

264. Carbamazepine Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

265. Carbamazepine, Pharmaceutical Secondary Standard; Certified Reference Material

266. N6w

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 236.27 g/mol
Molecular Formula C15H12N2O
XLogP32.5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass236.094963011 g/mol
Monoisotopic Mass236.094963011 g/mol
Topological Polar Surface Area46.3 Ų
Heavy Atom Count18
Formal Charge0
Complexity326
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 14  
Drug NameCarbamazepine
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelCarbamazepine USP is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 200 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structura...
Active IngredientCarbamazepine
Dosage FormTablet, extended release; Tablet; Capsule, extended release; Tablet, chewable; Suspension
Routeoral; Oral
Strength300mg; 200mg; 100mg; 100mg/5ml; 400mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Teva Pharms; Apotex; Teva Pharms Usa; Taro Pharm Inds; Taro; Torrent Pharms; Nostrum

2 of 14  
Drug NameCarbatrol
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelCARBATROL* is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically...
Active IngredientCarbamazepine
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 200mg; 100mg
Market StatusPrescription
CompanyShire

3 of 14  
Drug NameEpitol
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelEpitol, carbamazepine, USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: C15H12N...
Active IngredientCarbamazepine
Dosage FormTablet; Tablet, chewable
RouteOral
Strength200mg; 100mg
Market StatusPrescription
CompanyTeva

4 of 14  
Drug NameEquetro
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelEQUETRO (carbamazepine) is a mood stabilizer available for oral administration as 100 mg, 200 mg, and 300 mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in...
Active IngredientCarbamazepine
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 200mg; 100mg
Market StatusPrescription
CompanyValidus Pharms

5 of 14  
Drug NameTegretol
Drug LabelTegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100mg, tablets of 200mg, XR tablets of 100, 200, and 400mg, and as a suspension of 100...
Active IngredientCarbamazepine
Dosage FormTablet; Suspension; Tablet, chewable
RouteOral
Strength200mg; 100mg/5ml; 100mg
Market StatusPrescription
CompanyNovartis

6 of 14  
Drug NameTegretol-xr
Active IngredientCarbamazepine
Dosage FormTablet, extended release
RouteOral
Strength200mg; 400mg; 100mg
Market StatusPrescription
CompanyNovartis

7 of 14  
Drug NameTeril
Active IngredientCarbamazepine
Dosage FormSuspension
RouteOral
Strength100mg/5ml
Market StatusPrescription
CompanyTaro

8 of 14  
Drug NameCarbamazepine
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelCarbamazepine USP is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 200 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structura...
Active IngredientCarbamazepine
Dosage FormTablet, extended release; Tablet; Capsule, extended release; Tablet, chewable; Suspension
Routeoral; Oral
Strength300mg; 200mg; 100mg; 100mg/5ml; 400mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Teva Pharms; Apotex; Teva Pharms Usa; Taro Pharm Inds; Taro; Torrent Pharms; Nostrum

9 of 14  
Drug NameCarbatrol
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelCARBATROL* is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically...
Active IngredientCarbamazepine
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 200mg; 100mg
Market StatusPrescription
CompanyShire

10 of 14  
Drug NameEpitol
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelEpitol, carbamazepine, USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: C15H12N...
Active IngredientCarbamazepine
Dosage FormTablet; Tablet, chewable
RouteOral
Strength200mg; 100mg
Market StatusPrescription
CompanyTeva

11 of 14  
Drug NameEquetro
PubMed HealthCarbamazepine (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelEQUETRO (carbamazepine) is a mood stabilizer available for oral administration as 100 mg, 200 mg, and 300 mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in...
Active IngredientCarbamazepine
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 200mg; 100mg
Market StatusPrescription
CompanyValidus Pharms

12 of 14  
Drug NameTegretol
Drug LabelTegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100mg, tablets of 200mg, XR tablets of 100, 200, and 400mg, and as a suspension of 100...
Active IngredientCarbamazepine
Dosage FormTablet; Suspension; Tablet, chewable
RouteOral
Strength200mg; 100mg/5ml; 100mg
Market StatusPrescription
CompanyNovartis

13 of 14  
Drug NameTegretol-xr
Active IngredientCarbamazepine
Dosage FormTablet, extended release
RouteOral
Strength200mg; 400mg; 100mg
Market StatusPrescription
CompanyNovartis

14 of 14  
Drug NameTeril
Active IngredientCarbamazepine
Dosage FormSuspension
RouteOral
Strength100mg/5ml
Market StatusPrescription
CompanyTaro

4.2 Therapeutic Uses

Analgesics, Non-Narcotic; Anticonvulsants

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Carbamazepine has been shown to be effective in certain psychiatric disorders including schizoaffective illness, resistant schizophrenia, and dyscontrol syndrome, associated with limbic system dysfunction. /NOT included in US or Canadian product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Carbamazepine is used for the detoxification of alcoholics. It has been found to be effective in rapidly relieving anxiety and distress of acute alcohol withdrawal and for such symptoms as seizures, hyperexcitability, and sleep disturbances. /NOT included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Carbamazepine is used alone or with other agents such as clofibrate or chlorpropamide in the treatment of partial central diabetes insipidus. /NOT included in US or Canadian product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


For more Therapeutic Uses (Complete) data for CARBAMAZEPINE (10 total), please visit the HSDB record page.


4.3 Drug Warning

There have been a few cases of seizures and/or respiratory depression in neonates born to women receiving carbamazepine concomitantly with other anticonvulsant agents. A few cases of vomiting, diarrhea, and/or decreased feeding also have been reported in neonates born to women receiving carbamazepine; these symptoms may represent a neonatal withdrawal syndrome

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2223


Carbamazepine should not be used prophylactically during long periods of remission in trigeminal neuralgia.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Although carbamazepine has ... been reported to relieve dystonic attacks in children, reduce migraine attacks, and relieve intractable hiccups in some patients, its therapeutic efficacy in such cases has not been established.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Carbamazepine is not indicated for atypical or generalized absence seizures (petit mal) or myoclonic or atonic seizures.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


For more Drug Warnings (Complete) data for CARBAMAZEPINE (30 total), please visit the HSDB record page.


4.4 Drug Indication

Carbamazepine is indicated for the treatment of epilepsy and pain associated with true trigeminal neuralgia. In particular, carbamazepine has shown efficacy in treating mixed seizures, partial seizures with complex symptoms, and generalized tonic-clonic seizures. Carbamazepine is also indicated for the treatment of manic episodes and mixed manic-depressive episodes caused by bipolar I disorder. Some off-label, unapproved uses of carbamazepine include the treatment of alcohol withdrawal syndrome and restless leg syndrome.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

**General effects** Carbamazepine treats seizures and the symptoms of trigeminal neuralgia by inhibiting sodium channels. In bipolar 1 disorder, carbamazepine has been found to decrease mania symptoms in a clinically significant manner according to the Young Mania Rating Scale (YMRS). Carbamazepine has a narrow therapeutic index. **A note on genetic variation and carbamazepine use** In studies of Han Chinese ancestry patients, a pronounced association between the HLA-B*1502 genotype and Steven Johnson syndrome and/or toxic epidermal necrolysis (SJS/TEN) resulting from carbamazepine use was observed.


5.2 MeSH Pharmacological Classification

Antimanic Agents

Agents that are used to treat bipolar disorders or mania associated with other affective disorders. (See all compounds classified as Antimanic Agents.)


Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


Cytochrome P-450 CYP3A Inducers

Drugs and compounds that induce the synthesis of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inducers.)


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.)


Sodium Channel Blockers

A class of drugs that act by inhibition of sodium influx through cell membranes. Blockade of sodium channels slows the rate and amplitude of initial rapid depolarization, reduces cell excitability, and reduces conduction velocity. (See all compounds classified as Sodium Channel Blockers.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
CARBAMAZEPINE
5.3.2 FDA UNII
33CM23913M
5.3.3 Pharmacological Classes
Cytochrome P450 2B6 Inducers [MoA]; Cytochrome P450 2C19 Inducers [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 3A4 Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Mood Stabilizer [EPC]; Cytochrome P450 1A2 Inducers [MoA]
5.4 ATC Code

N03AF01

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


N03AF01

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


N03AF01

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


N03AF01

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


N - Nervous system

N03 - Antiepileptics

N03A - Antiepileptics

N03AF - Carboxamide derivatives

N03AF01 - Carbamazepine


5.5 Absorption, Distribution and Excretion

Absorption

The bioavailability of carbamazepine is in the range of 75-85% of an ingested dose. After one 200 mg oral extended-release dose of carbamazepine in a pharmacokinetic study, the Cmax carbamazepine was measured to be 1.9 0.3 mcg/mL. The Tmax was 19 7 hours. After several doses of 800 mg every 12 hours, the peak concentrations of carbamazepine were measured to be 11.0 2.5 mcg/mL. The Tmax was reduced to 5.9 1.8 hours. Extended-release carbamazepine demonstrated linear pharmacokinetics over a range of 200800 mg. **Effect of food on absorption** A meal containing high-fat content increased the rate of absorption of one 400 mg dose but not the AUC of carbamazepine. The elimination half-life remained unchanged between fed and fasting state. The pharmacokinetics of an extended-release carbamazepine dose was demonstrated to be similar when administered in the fasted state or with food. Based on these findings, food intake is unlikely to exert significant effects on carbamazepine absorption.


Route of Elimination

After an oral dose of radiolabeled carbamazepine, 72% of the administered radioactive dose was detected in the urine and the remainder of the ingested dose was found in the feces. Carbamazepine is mainly excreted as hydroxylated and conjugated metabolites, and minimal amounts of unchanged drug.


Volume of Distribution

The volume of distribution of carbamazepine was found to be 1.0 L/kg in one pharmacokinetic study. Another study indicates that the volume of distribution of carbamazepine ranges between 0.7 to 1.4 L/kg.. Carbamazepine crosses the placenta, and higher concentrations of this drug are found in the liver and kidney as opposed to lung and brain tissue. Carbamazepine crosses variably through the blood-brain barrier.


Clearance

In a pharmacokinetic study, the apparent oral clearance of carbamazepine was 25 5 mL/min after one dose of carbamazepine and 80 30 mL/min after several doses.


Absorption: Slow and variable, but almost completely absorbed from gastrointestinal tract.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Patients in whom carbamazepine monotherapy is discontinued for preoperative EEG/video monitoring often display toxicity if their previous maintenance dosage is resumed, even after a few days without carbamazepine. To determine whether this is due to rapid reversibility of autoinduction of carbamazepine metabolism, single-dose studies of carbamazepine pharmacokinetics were performed before and after discontinuation for monitoring in 6 adults receiving carbamazepine monotherapy. The carbamazepine-free period was 5.7 + or - 1.1 days (mean + or - SD). The pharmacokinetic parameters of carbamazepine before and after discontinuation were volume of distribution 1.28 + or - 0.29 versus 1.22 + or - 0.331/kg, elimination half-life (tl/2) 13.7 + or - 1.67 versus 22.2 + or - 2.36 hr (p < 0.001), and clearance 1.54 + or - 0.39 versus 0.92 + or - 0.32 L/kg/day (p = 0.012). Assuming that deinduction is a first-order process, a deinduction tl/2 of 3.84 days was obtained by log linear regression analysis. We showed that after carbamazepine discontinuation half of the enzymatic autoinduction is already lost after 3.84 days, indicating very rapid deinduction. Our results also provide the necessary information to predict clearance and appropriate dosage reduction for carbamazepine at time of reintroduction.

PMID:8112245 Schaffler L et al; Epilepsia 35 (1): 195-8 (1994)


This study was designed to evaluate the usefulness of carbamazepine as a probe in screening for host factor influences on human drug metabolism. Nine healthy nonsmoking volunteers ingested a single oral dose of carbamazepine in doses ranging from 400 to 500 milligrams. Fluorescence polarization immunoassay measurements of carbamazepine concentrations in plasma and plasma ultrafiltrates from 0 to 48 hours after dosing were used to calculate clearance, volume of distribution, and clearance of plasma unbound drug. Blood samples collected 48 hours after dosing gave single sample estimates of carbamazepine clearance which were closest to multiple sample values for clearance. This was also the case for plasma total carbamazepine and plasma unbound carbamazepine. In calculating all single sample estimates of clearance, a value of 1.1 L/kg was used for V and a value of 4.3 L/kg was used to calculate the single sample estimates of clearance of plasma unbound drug. The mean prediction error was less than 5 percent errant for clearance and less than 1 percent errant for clearance of plasma unbound drug when the parameters were calculated from 48 hour concentrations of plasma total carbamazepine or plasma unbound carbamazepine, respectively. ...

PMID:2773507 Bachmann KA et al; Xenobiotica 19 (7): 711-719 (1989)


A fatal overdose of carbamazepine with both timely antemortem and postmortem carbamazepine concentrations /was reported/. Carbamazepine concentrations were 47.7 ug/mL 2 hr antemortem and 53 ug/mL at 9 hr postmortem. The slight rise in drug concentration may reflect continued absorption of the drug in the last 2 hr before death. Postmortem carbamazepine concentrations drawn from a peripheral vessel in this patient appeared to reflect drug concentrations at the time of death.

PMID:11714170 Spiller HA, Carlisle RD; J Forensic Sci 46 (6): 1510-2 (2001)


For more Absorption, Distribution and Excretion (Complete) data for CARBAMAZEPINE (15 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Carbamazepine is largely metabolized in the liver. CYP3A4 hepatic enzyme is the major enzyme that metabolizes carbamazepine to its active metabolite, carbamazepine-10,11-epoxide, which is further metabolized to its trans-diol form by the enzyme epoxide hydrolase. Other hepatic cytochrome enzymes that contribute to the metabolism of carbamazepine are CYP2C8, CYP3A5, and CYP2B6. Carbamazepine also undergoes hepatic glucuronidation by UGT2B7 enzyme and several other metabolic reactions occur, resulting in the formation of minor hydroxy metabolites and quinone metabolites. Interestingly, carbamazepine induces its own metabolism. This leads to enhanced clearance, reduced half-life, and a reduction in serum levels of carbamazepine.


The pharmacokinetics of a single oral dose of carbamazepine-10,11-epoxide, (100 mg) were compared in 10 patients on chronic monotherapy with lamotrigine, (200-300 mg/day) and in 10 drug-free healthy control subjects. Carbamazepine-10,11-epoxide pharmacokinetic parameters in lamotridge-treated patients were found to be similar to those observed in controls (half-life: 7.2 + or - 1.6 vs 6.1 + or - 0.9 hr; apparent oral clearance: 110.8 + or - 53.1 vs 120.5 + or - 29.9 ml/h/kg; apparent volume of distribution: 1.08 + or 0.37 vs 1.04 + or - 0.25 l/kg respectively; means + or - s.d.). These data indicate that, contrary to previous suggestions, lamotridge has no effect on the metabolic disposition of carbamazepine-10,11-epoxide.

PMID:7698101 Pisani F et al; Epilepsy Res 19 (3): 245-8 (1994)


Placental transfer and metabolism of carbamazepine was studied in a dual recirculating placental cotyledon perfusion system and was also evaluated in 16 pairs of maternal venous and cord blood samples. ... Carbamazepine added into the maternal circulation crosses the placenta in the beginning quicker than antipyrine which is in agreement with the different lipid solubilities of these compounds. Because the transfer rates of antipyrine and carbamazepine were about the same, the mechanism of transfer of carbamazepine is probably similar to that of antipyrine (passive diffusion). No metabolites of carbamazepine could be detected in the perfusate by high-performance liquid chromatography or gas chromatography/mass spectrometry. With the improved HPLC methodology for carbamazepine metabolites, six metabolites were detected in clinical samples, including 10-hydroxy-10,11-dihydro-carbamazepine (10-OH-CBZ), which has been described earlier in only 1 uremic patient. Relative levels of metabolites showed significant individual differences. Carbamazepine crosses perfused placenta rapidly, but this does not contribute to carbamazepine metabolites detected in maternal and fetal circulation.

PMID:7614907 Pienimaki P et al; Epilepsia 36 (3): 241-8 (1995)


The aim of this work was to study the transport across the blood-brain barrier, blood and liver distribution kinetics, metabolic interaction and local liver metabolism of carbamazepine in the rat, using microdialysis with the internal standard technique as in vivo calibration method. Carbamazepine and its major metabolite, carbamazepine-10,11-epoxide, are homogeneously distributed to hippocampus and cerebellum. The ratios of the areas under the concentration-time curve for both brain regions to blood areas under the concentration-time curve were not different from unity for carbamazepine; they were 0.46 + or - 0.08 (hippocampus) and 0.45 + or - 0.05 (cerebellum) for carbamazepine-10,11-epoxide. In addition, the disposition of carbamazepine and carbamazepine-10,11-epoxide in blood and liver, after a single dose of carbamazepine, was studied in control animals and in rats after pretreatment with clomipramine. A 2-fold increase in the blood areas under concentration curve of carbamazepine and a decrease to 33% of the blood areas under concentration curve of carbamazepine-10,11-epoxide in the pretreated group demonstrate the metabolic inhibition of carbamazepine-10,11-epoxide formation by clomipramine. The ratios of the areas under concentration curve carbamazepine-10,11-epoxide to the areas under the concentration curve carbamazepine, as a measure of carbamazepine-10,11-epoxide formation, were not different for blood and liver within the control and the clomipramine-pretreated groups, but the ratios were significantly lower for liver and blood in the clomipramine group compared with the control animals. In addition, carbamazepine was administered locally in the extracellular fluid of the liver via the microdialysis probe. The liver metabolic ratio, expressed as the ratio of the formed carbamazepine-10,11-epoxide concentration to the carbamazepine concentration administered, ranged from 18.2 + or - 1.2% to 19.6 + or - 1.6%.

PMID:7891336 Van Belle K et al; J Pharmacol Exp Ther 272 (3): 1217-22 (1995)


Carbamazepine has known human metabolites that include 2-Hydroxycarbamazepine, 3-Hydroxycarbamazepine, 9-Hydroxycarbamazepine, and Carbamazepine 10,11-epoxide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

The mean elimination half-life of carbamazepine was 35 to 40 hours after one dose of carbamazepine extended-release formulations. The half-life ranged from 12-17 hours after several doses of carbamazepine. One pharmacokinetic study determined the elimination half-life of carbamazepine to range between 27 to 36.8 hours in healthy volunteers.


Initial single dose: May range from 25 to 65 hours. Chronic dosing: May decrease to 8 to 29 hours (average 12 to 17 hours) because of autoinduciton of metabolism.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Carbamazepine-10,11-epoxide: 5 to 8 hours. /Carbamazepine-10,11-epoxide/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


5.8 Mechanism of Action

Carbamazepine's mechanism of action is not fully elucidated and is widely debated. One major hypothesis is that carbamazepine inhibits sodium channel firing, treating seizure activity. Animal research studies have demonstrated that carbamazepine exerts its effects by lowering polysynaptic nerve response and inhibiting post-tetanic potentiation. In both cats and rats, carbamazepine was shown to decrease pain caused by infraorbital nerve stimulation. A decrease in the action potential in the nucleus ventralis of the thalamus in the brain and inhibition of the lingual mandibular reflex were observed in other studies after carbamazepine use. Carbamazepine causes the above effects by binding to voltage-dependent sodium channels and preventing action potentials, which normally lead to stimulatory effects on nerves. In bipolar disorder, carbamazepine is thought to increase dopamine turnover and increase GABA transmission, treating manic and depressive symptoms. A common issue that has arisen is resistance to this drug in up to 30% of epileptic patients, which may occur to altered metabolism in patients with variant genotypes. A potential therapeutic target to combat carbamazepine resistance has recently been identified as the EPHX1 gene promoter, potentially conferring resistance to carbamazepine through methylation.


Anticonvulsant: Exact mechanism unknown; may act postsynaptically by limiting the ability of neurons to sustain high frequency repetitive firing of action potentials through enhancement of sodium channel inactivation; in addition to altering neuronal excitability, may act presynaptically to block the release of neurotransmitter by blocking presynaptic sodium channels and the firing of action potentials, which in turn decreases synaptic transmission.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Antineuralgic: Exact mechanism unknown; may involve gamma-aminobutyric acid (GABAB) receptors, which may be linked to calcium channels.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Antimanic; antipsychotic: Exact mechanism is unknown; may be related to either the anticonvulsant or the antineuralgic effects of carbamazepine, or to tis effects on neurotransmitter modulator systems.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


Antidiuretic: Exact mechanism unknown; may exert a hypothalamic effect on the osmoreceptors mediated via secretion of antidiuretic hormone (ADH), or may have a direct effect on the renal tubule.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 703


For more Mechanism of Action (Complete) data for CARBAMAZEPINE (8 total), please visit the HSDB record page.


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INDL.ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721327400,"product":"CARBAMAZEPINE","address":"25, 2ND PULIYUR MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"ZHEJIANG JIUZHOU PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"710.00","actualQuantity":"710","unit":"KGS","unitRateFc":"48","totalValueFC":"34430.2","currency":"USD","unitRateINR":"4053.6","date":"19-Jul-2024","totalValueINR":"2878056","totalValueInUsd":"34430.2","indian_port":"Madras Sea","hs_no":"29420090","bill_no":"4586395","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"WAISHA ROAD 99, JIAOJIANG,TAIZHOU CITY, ZHEJIANGSDNF CHINA","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"OXCARBAZEPINE USP","address":"MEDLEY HOUSE,D-2,MIDC AREA","city":"MUMBAI","supplier":"HUBEI GEDIAN HUMANWELL PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"WUHAN","customer":"MEDLEY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"160","totalValueFC":"97201.4","currency":"USD","unitRateINR":"13576","date":"05-Sep-2024","totalValueINR":"8145600","totalValueInUsd":"97201.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"5438610","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"WUHAN","supplierAddress":"GEDIAN ECONOMIC DEVELOPMENT DISTRIC T E-ZHOU (436070), HUBEI,CHINA Zhou kou, , China China China","customerAddress":"MEDLEY HOUSE,D-2,MIDC AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730745000,"product":"(REJECTED AND RETURN )OXC2305140 OXCARBAZEPINE (SB NOS: 2117144 \/DT:30.6.2023)","address":"PLOT NO.1-A SEC-16A","city":"NOIDA (U.P) INDIA","supplier":"ALFRED E TIEFENBACHER GMBH","supplierCountry":"GERMANY","foreign_port":"HAMBURG","customer":"JUBILANT PHARMOVA","customerCountry":"INDIA","quantity":"154.39","actualQuantity":"154.39","unit":"KGS","unitRateFc":"215","totalValueFC":"33735.6","currency":"USD","unitRateINR":"18439.6","date":"05-Nov-2024","totalValueINR":"2846888.47","totalValueInUsd":"33735.6","indian_port":"Bangalore ICD","hs_no":"29339990","bill_no":"6502679","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG","supplierAddress":"VAN-DER-SMISSEN-STRASSE 1-2 22767 H AMBURG GERMANY ., , Germany SDNF Germany","customerAddress":"PLOT NO.1-A SEC-16A"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"OXCARBAZEPINE. B\/N: F-NOXC240701-1M1. MFG. DT. 14\/07\/2024 RETEST DT. 13\/04\/2027OXCARBAZEPINE. B\/N: F-NOXC240701-1M1. MFG. DT. 14\/07\/2024 RE","address":"SUR. NO. 377\/1B, BS. UDHYAN BUNGLO","city":"AHMEDABAD,GUJARAT","supplier":"HUBEI GEDIAN HUMANWELL PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"XYLOPIA LABS PRIVATE ","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"190","totalValueFC":"4788.1","currency":"USD","unitRateINR":"16273.5","date":"19-Dec-2024","totalValueINR":"406837.5","totalValueInUsd":"4788.1","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"7330651","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"GEDIAN ECONOMIC DEVELOPMENT DISTRIC T, E-ZHOU (436070) HUBEI, CHINA SDNF CHINA","customerAddress":"SUR. NO. 377\/1B, BS. UDHYAN BUNGLO"}]
02-Jan-2021
29-Mar-2025
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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 16608

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

USFDA APPLICATION NUMBER - 20234

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

USFDA APPLICATION NUMBER - 20234

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 400M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 400MG

USFDA APPLICATION NUMBER - 20234

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DOSAGE - SOLUTION;INTRAVENOUS - 200MG/20ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 200MG/20ML (10MG/ML)

USFDA APPLICATION NUMBER - 206030

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG

USFDA APPLICATION NUMBER - 20712

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG

USFDA APPLICATION NUMBER - 20712

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG

USFDA APPLICATION NUMBER - 20712

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ABOUT THIS PAGE

Looking for 298-46-4 / Carbamazepine API manufacturers, exporters & distributors?

Carbamazepine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Carbamazepine

Synonyms

298-46-4, Tegretol, Carbamazepen, Finlepsin, Biston, 5h-dibenzo[b,f]azepine-5-carboxamide

Cas Number

298-46-4

Unique Ingredient Identifier (UNII)

33CM23913M

About Carbamazepine

A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.

Carbamazepina Manufacturers

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

Carbamazepina Suppliers

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

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

Carbamazepina USDMF

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

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

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

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

Carbamazepina KDMF

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

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

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

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

Carbamazepina CEP

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

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

Carbamazepina WC

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

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

Carbamazepina 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 Carbamazepina as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Carbamazepina GMP

Carbamazepina 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 Carbamazepina 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 Carbamazepina GMP manufacturer or Carbamazepina GMP API supplier for your needs.

Carbamazepina CoA

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

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

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