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Chemistry

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Also known as: 33286-22-5, Diltiazem hcl, Cardizem, Dilzem, Dilzene, Masdil
Molecular Formula
C22H27ClN2O4S
Molecular Weight
451.0  g/mol
InChI Key
HDRXZJPWHTXQRI-BHDTVMLSSA-N
FDA UNII
OLH94387TE

Diltiazem Hydrochloride
A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.
1 2D Structure

Diltiazem Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2S,3S)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] acetate;hydrochloride
2.1.2 InChI
InChI=1S/C22H26N2O4S.ClH/c1-15(25)28-20-21(16-9-11-17(27-4)12-10-16)29-19-8-6-5-7-18(19)24(22(20)26)14-13-23(2)3;/h5-12,20-21H,13-14H2,1-4H3;1H/t20-,21+;/m1./s1
2.1.3 InChI Key
HDRXZJPWHTXQRI-BHDTVMLSSA-N
2.1.4 Canonical SMILES
CC(=O)OC1C(SC2=CC=CC=C2N(C1=O)CCN(C)C)C3=CC=C(C=C3)OC.Cl
2.1.5 Isomeric SMILES
CC(=O)O[C@@H]1[C@@H](SC2=CC=CC=C2N(C1=O)CCN(C)C)C3=CC=C(C=C3)OC.Cl
2.2 Other Identifiers
2.2.1 UNII
OLH94387TE
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aldizem

2. Cardil

3. Cardizem

4. Crd 401

5. Crd-401

6. Crd401

7. Dilacor

8. Dilacor Xr

9. Dilren

10. Diltiazem

11. Diltiazem Malate

12. Dilzem

13. Tiazac

2.3.2 Depositor-Supplied Synonyms

1. 33286-22-5

2. Diltiazem Hcl

3. Cardizem

4. Dilzem

5. Dilzene

6. Masdil

7. (+)-cis-diltiazem Hydrochloride

8. Tiazac

9. Crd-401

10. Altiazem

11. Deltazen

12. Diladel

13. Dilpral

14. Dilrene

15. Tildiem

16. Adizem

17. Herbesser

18. Dilacor

19. Lacerol

20. Zilden

21. Mono-tildiem

22. Bi-tildiem

23. Cardizem Cd

24. Cardizem La

25. Cardil

26. Dilren

27. Dilthiazem Hydrochloride

28. Diltiazem (hydrochloride)

29. Diltzac

30. Cartia

31. Rg 83606

32. (2s,3s)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl Acetate Hydrochloride

33. Taztia

34. Diltiazem Hcl (tiazac)

35. 103532-26-9

36. Mls000028432

37. Olh94387te

38. Rg 83606 Hcl

39. Chebi:645509

40. Anoheal

41. Nsc-759576

42. (+)-5-(2-(dimethylamino)ethyl)-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Acetate (ester) Monohydrochloride

43. (2s,3s)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate Hydrochloride

44. [(2s,3s)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] Acetate;hydrochloride

45. 38411-61-9

46. Dilzicardin

47. Anginyl

48. Angitil

49. Angizem

50. Britiazim

51. Calcicard

52. Calnurs

53. Cardiazem

54. Cirilen

55. Citizen

56. Clarute

57. Corazet

58. Dilatam

59. Dilatame

60. Dilcard

61. Dilgard

62. Dilicardin

63. Diltahexal

64. Diltelan

65. Diltiasyn

66. Diltikor

67. Diltime

68. Dinisor

69. Dodexen

70. Entrydil

71. Farmabes

72. Gadoserin

73. Helsibon

74. Incoril

75. Kaltiazen

76. Levozem

77. Longazem

78. Lytelsen

79. Metazem

80. Miocardie

81. Oxycardil

82. Pazeadin

83. Pentilzeno

84. Poltiazem

85. Presoken

86. Rg-83606

87. Smr000058375

88. Tilazem

89. Trumsal

90. Ziruvate

91. Bruzem

92. Carzem

93. Diatal

94. Dilfar

95. Dilsal

96. Diltam

97. Diltan

98. Doclis

99. Dyalac

100. Etizen

101. Etyzen

102. Herben

103. Kardil

104. Myonil

105. Slozen

106. Tiadil

107. Tiaves

108. Ubicor

109. Zildem

110. Carex

111. Coras

112. Dazil

113. Dilem

114. Dilso

115. Hesor

116. Tazem

117. Apo-diltiazem

118. Iski

119. Altiazem Retard

120. Cardizem Retard

121. Diltiazem Merck

122. Diltiazem Stada

123. Diltiazem Verla

124. Diltiazem-mepha

125. 33286-22-5 (hcl)

126. Cardil Retard

127. Dil-sonaramia

128. Diltiazem-isis

129. Dilzem Retard

130. Dinisor Retard

131. Myonil Retard

132. Novo-diltazem

133. Syn-diltiazem

134. Tildiem Retard

135. Diltiazem Basics

136. Diltiazem-cophar

137. Mfcd00069252

138. Uni Masdil

139. Wl Diltiazem

140. Altiazem Rr

141. Cardizem Sr

142. Diltiazem Awd

143. Diltiazem Gnr

144. Diltiazem Msd

145. Diltiazem-gry

146. Cirilen Ap

147. Diltiazem Henning

148. Diltiazem Upsa

149. Tildiem Cr

150. Tildiem La

151. Adizem-cd

152. Cartia Xt

153. Diltan Sr

154. Diltiazem Eu Rho

155. Dilzem Rr

156. Taztia Xt

157. Viazem Sr

158. Viazem Xl

159. Herbesser 60

160. (2s-cis)-3-acetoxy-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Monohydrochloride

161. [(2s,3s)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] Acetate;hydron;chloride

162. 1,5-benzothiazepin-4(5h)-one, 3-(acetyloxy)-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-, Monohydrochloride, (+)-cis-

163. Herbesser 90 Sr

164. Tilazem 90

165. Diltiazem Chloridrate

166. Dilatam 120

167. Tilazem As 60

168. Tilazem As 90

169. Dilzereal 90 Retard

170. Herbesser 180 Sr

171. Dolizem

172. Iski-90 Sr

173. Diltia Xt

174. Dilt-xr

175. Dodexen A.p.

176. Presokin A. P.

177. Mk-793

178. Crd 401

179. Tiazac Extended Release

180. Sr-01000003042

181. Einecs 251-443-3

182. Dilacor Xr Extended Release Capsules

183. Unii-olh94387te

184. Milptin

185. Carzen

186. Slozem

187. Crd401

188. Dilthiazem Hcl

189. Dov Diltiazem

190. Uni-masdil

191. Cardizem Xl

192. Tiazac Xc

193. Cardizem (tn)

194. Prestwick_176

195. Acetate Hydrochloride

196. Einecs 253-918-0

197. Dilacor Xr (tn)

198. Cartia Xt (tn)

199. Opera_id_79

200. Diltiazem Hydrochloride [usan:usp:jan]

201. Dilt-cd (tn)

202. (+)-5-(2-(dimethylamino)ethyl)-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Acetate Ester Monohydrochloride

203. 2-[(2s,3s)-3-(acetyloxy)-2-(4-methoxyphenyl)-4-oxo-3,4-dihydro-1,5-benzothiazepin-5(2h)-yl]-n,n-dimethylethanaminium Chloride

204. Chembl1697

205. Diltiazem Hydrochloride,(s)

206. Schembl15457

207. Mls001148257

208. Mls002222179

209. Diltiazem Hcl [vandf]

210. (+)-cis-diltiazem Hydrochlorid

211. Diltiazem For System Suitability

212. Dtxsid8040147

213. Amy8835

214. Slv-324

215. Ven-307

216. Hms1568k10

217. (2s-trans)-diltiazem Hydrochloride

218. Act02682

219. Bcp13814

220. Diltiazem Hydrochloride [mi]

221. Tox21_500327

222. Bnp-32762

223. Diltiazem Hydrochloride (jp17/usp)

224. Diltiazem Hydrochloride [jan]

225. S1865

226. 3,3,3-phosphinylidynetrispropionamide

227. Diltiazem Hydrochloride [usan]

228. Akos015961992

229. Ccg-220134

230. Ccg-221631

231. Diltiazem Hydrochloride [mart.]

232. Diltiazem Hydrochloride [vandf]

233. Ks-5089

234. Lp00327

235. Nc00558

236. Nsc 759576

237. Diltiazem Hydrochloride [usp-rs]

238. Diltiazem Hydrochloride [who-dd]

239. Tetrahydrobenzo[b][1,4]thiazepin-3-yl

240. Ncgc00093768-01

241. Ncgc00261012-01

242. (2s,3s)-(+)-3-acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Hydrochloride

243. 1,5-benzothiazepin-4(5h)-one, 2,3-dihydro-3-(acetyloxy)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-, Monohydrochloride, Cis-(+)-

244. Ac-15189

245. Ac-32469

246. As-13703

247. Bd166408

248. Cis-(1)-3-acetoxy-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Monohydrochloride

249. Hy-14656

250. (+)-cis-diltiazem Hydrochloride, >/=98%

251. (2s,3s)-5-(2-(dimethylamino)ethyl)-2

252. D3662

253. Diltiazem Hydrochloride [ep Impurity]

254. Diltiazem Hydrochloride [orange Book]

255. Eu-0100327

256. Sw196487-3

257. Diltiazem Hydrochloride [ep Monograph]

258. Bim-0050315.0001

259. D 2521

260. D00616

261. Diltiazem Hydrochloride [usp Monograph]

262. Diltiazem, Hydrochloride - Cas 33286-22-5

263. F20448

264. M01693

265. (+)-cis-diltiazem Hydrochloride, >=99% (hplc)

266. 286d225

267. Sr-01000075327

268. J-019130

269. Sr-01000003042-2

270. Sr-01000003042-4

271. Sr-01000075327-1

272. Q27105183

273. Diltiazem Hydrochloride 1.0 Mg/ml In Acetonitrile (as Free Base)

274. Diltiazem Hydrochloride, European Pharmacopoeia (ep) Reference Standard

275. Diltiazem Hydrochloride, United States Pharmacopeia (usp) Reference Standard

276. Diltiazem For System Suitability, European Pharmacopoeia (ep) Reference Standard

277. (2s,3s)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl Acetate Hcl

278. (2s,3s)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-ylacetatehydrochloride

279. (2s-cis)-3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one Hydrochloride

280. 1,5-benzothiazepin-4(5h)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, Hydrochloride (1:1), (2s,3s)-

281. Acetic Acid (2s,3s)-5-(2-dimethylamino-ethyl)-2-(4-methoxy-phenyl)-4-oxo-2,3,4,5-tetrahydro-benzo[b][1,4]thiazepin-3-yl Ester; Hydrochloride

282. Cis-(+)-3-acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-1,5-benzothiazepine-4(5h)-one Hydrochloride

283. Diltiazem Hydrochloride Solution, 1.0 Mg/ml In Acetonitrile (as Free Base), Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 451.0 g/mol
Molecular Formula C22H27ClN2O4S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count7
Exact Mass450.1380062 g/mol
Monoisotopic Mass450.1380062 g/mol
Topological Polar Surface Area84.4 Ų
Heavy Atom Count30
Formal Charge0
Complexity565
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 16  
Drug NameCardizem
PubMed HealthDiltiazem
Drug ClassesAntianginal, Antihypertensive, Benzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelCARDIZEM (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet
RouteOral
Strength60mg; 30mg; 90mg; 120mg
Market StatusPrescription
CompanyValeant Intl

2 of 16  
Drug NameCardizem cd
Drug LabelCARDIZEM (diltiazem hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-metho...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 180mg; 120mg; 360mg; 240mg
Market StatusPrescription
CompanyValeant Intl

3 of 16  
Drug NameCardizem la
PubMed HealthDiltiazem
Drug ClassesAntianginal, Antihypertensive, Benzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelCARDIZEM LA (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength300mg; 180mg; 420mg; 120mg; 360mg; 240mg
Market StatusPrescription
CompanyValeant Intl

4 of 16  
Drug NameCartia xt
PubMed HealthDiltiazem (Intravenous route)
Drug ClassesBenzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelDiltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphen...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 180mg; 120mg; 240mg
Market StatusPrescription
CompanyActavis Labs Fl

5 of 16  
Drug NameDilacor xr
Drug LabelDILACOR XR (diltiazem hydrochloride, USP) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 120mg; 240mg
Market StatusPrescription
CompanyWatson Labs

6 of 16  
Drug NameDiltiazem hydrochloride
Drug LabelDiltiazem is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet, extended release; Injectable; Tablet; Capsule, extended release
Routeinjection; Injection; Oral
Strength300mg; 50mg/10ml; 180mg; 100mg/vial; 5mg/ml; 30mg; 60mg; 90mg; 125mg/25ml; 420mg; 120mg; 10mg/ml; 360mg; 240mg
Market StatusPrescription
CompanyIntl Medication; Bedford; Valeant Intl; Hospira; Hikma Maple; Actavis Labs Fl; Teva; Apotex; Hikma Farmaceutica; Teva Pharms Usa; Sandoz; Sun Pharma Global; Par Pharm; Mylan; Actavis; Akorn

7 of 16  
Drug NameTaztia xt
Drug LabelTAZTIA XT brand ofDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASECAPSULES USP(ONCE-A-DAY DOSAGE)Rx Only...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 120mg; 360mg; 300mg; 240mg
Market StatusPrescription
CompanyActavis Labs Fl

8 of 16  
Drug NameTiazac
Drug LabelTiazac (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, mon...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 420mg; 120mg; 360mg; 300mg; 240mg
Market StatusPrescription
CompanyValeant Intl

9 of 16  
Drug NameCardizem
PubMed HealthDiltiazem
Drug ClassesAntianginal, Antihypertensive, Benzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelCARDIZEM (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet
RouteOral
Strength60mg; 30mg; 90mg; 120mg
Market StatusPrescription
CompanyValeant Intl

10 of 16  
Drug NameCardizem cd
Drug LabelCARDIZEM (diltiazem hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-metho...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 180mg; 120mg; 360mg; 240mg
Market StatusPrescription
CompanyValeant Intl

11 of 16  
Drug NameCardizem la
PubMed HealthDiltiazem
Drug ClassesAntianginal, Antihypertensive, Benzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelCARDIZEM LA (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength300mg; 180mg; 420mg; 120mg; 360mg; 240mg
Market StatusPrescription
CompanyValeant Intl

12 of 16  
Drug NameCartia xt
PubMed HealthDiltiazem (Intravenous route)
Drug ClassesBenzothiazepine, Calcium Channel Blocker, Cardiovascular Agent
Drug LabelDiltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphen...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength300mg; 180mg; 120mg; 240mg
Market StatusPrescription
CompanyActavis Labs Fl

13 of 16  
Drug NameDilacor xr
Drug LabelDILACOR XR (diltiazem hydrochloride, USP) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 120mg; 240mg
Market StatusPrescription
CompanyWatson Labs

14 of 16  
Drug NameDiltiazem hydrochloride
Drug LabelDiltiazem is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride...
Active IngredientDiltiazem hydrochloride
Dosage FormTablet, extended release; Injectable; Tablet; Capsule, extended release
Routeinjection; Injection; Oral
Strength300mg; 50mg/10ml; 180mg; 100mg/vial; 5mg/ml; 30mg; 60mg; 90mg; 125mg/25ml; 420mg; 120mg; 10mg/ml; 360mg; 240mg
Market StatusPrescription
CompanyIntl Medication; Bedford; Valeant Intl; Hospira; Hikma Maple; Actavis Labs Fl; Teva; Apotex; Hikma Farmaceutica; Teva Pharms Usa; Sandoz; Sun Pharma Global; Par Pharm; Mylan; Actavis; Akorn

15 of 16  
Drug NameTaztia xt
Drug LabelTAZTIA XT brand ofDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASECAPSULES USP(ONCE-A-DAY DOSAGE)Rx Only...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 120mg; 360mg; 300mg; 240mg
Market StatusPrescription
CompanyActavis Labs Fl

16 of 16  
Drug NameTiazac
Drug LabelTiazac (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, mon...
Active IngredientDiltiazem hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength180mg; 420mg; 120mg; 360mg; 300mg; 240mg
Market StatusPrescription
CompanyValeant Intl

4.2 Drug Indication

Treatment of chronic anal fissure


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)


Cardiovascular Agents

Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. (See all compounds classified as Cardiovascular Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Calcium Channel Blocker [EPC]; Calcium Channel Antagonists [MoA]

API SUPPLIERS

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USDMF

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01

Fermion Oy

Finland
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DMF Review : Complete

Rev. Date : 2017-02-01

Pay. Date : 2016-12-29

DMF Number : 5717

Submission : 1985-02-06

Status : Active

Type : II

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02

  • fda
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Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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DMF Review : Complete

Rev. Date : 2012-11-29

Pay. Date : 2012-11-08

DMF Number : 7239

Submission : 1987-11-30

Status : Active

Type : II

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03

Pharma, Lab & Chemical Expo
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03

Pharma, Lab & Chemical Expo
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GDUFA

DMF Review : Complete

Rev. Date : 2021-03-18

Pay. Date : 2021-03-15

DMF Number : 6761

Submission : 1987-01-05

Status : Active

Type : II

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Pharma, Lab & Chemical Expo
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GDUFA

DMF Review : Complete

Rev. Date : 2013-01-18

Pay. Date : 2012-12-12

DMF Number : 7600

Submission : 1988-07-18

Status : Active

Type : II

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05

Lusochimica Spa

Italy

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06

Maprimed Sa

Argentina

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Maprimed Sa

Argentina
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DMF Number : 7887

Submission : 1989-02-07

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07

Tanabe Seiyaku Co Ltd

Japan

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DMF Number : 3059

Submission : 1977-11-11

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08

Siegfried Ag

Switzerland

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Siegfried Ag

Switzerland
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DMF Number : 7540

Submission : 1988-06-16

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Torcan Chemical Ltd

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Torcan Chemical Ltd

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DMF Number : 7240

Submission : 1987-10-26

Status : Inactive

Type : II

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MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636482600,"product":"DILTIAZEM HYDROCHLORIDE USP-DILTIAZEM HCI, USP","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"ITALY","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"60.10","actualQuantity":"60.1","unit":"KGS","unitRateFc":"82.5","totalValueFC":"5030.1","currency":"USD","unitRateINR":"6232.9","date":"10-Nov-2021","totalValueINR":"374595.79","totalValueInUsd":"5030.1","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"6187562","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636482600,"product":"DILTIAZEM HYDROCHLORIDE USP-DILTIAZEM HCI, USP","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"ITALY","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"576.60","actualQuantity":"576.6","unit":"KGS","unitRateFc":"82.5","totalValueFC":"48258.6","currency":"USD","unitRateINR":"6232.9","date":"10-Nov-2021","totalValueINR":"3593875.72","totalValueInUsd":"48258.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"6187562","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636482600,"product":"DILTIAZEM HYDROCHLORIDE USP-DILTIAZEM HCI, USP","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"ITALY","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"646.50","actualQuantity":"646.5","unit":"KGS","unitRateFc":"82.5","totalValueFC":"54108.8","currency":"USD","unitRateINR":"6232.9","date":"10-Nov-2021","totalValueINR":"4029553.69","totalValueInUsd":"54108.8","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"6187562","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663439400,"product":"DILTIAZEM HYDROCHLORIDE","address":"688, Ground Floor, 6th Main, III Block, Bel lay, Vidyaranyapura","city":"BANGALORE","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"NA","customer":"MAIVA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"16.00","actualQuantity":"16","unit":"KGS","unitRateFc":"980","totalValueFC":"15730.7","currency":"USD","unitRateINR":"78792","date":"18-Sep-2022","totalValueINR":"1260672","totalValueInUsd":"15730.7","indian_port":"BANGALORE AIR","hs_no":"29349990","bill_no":"2496239","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"688, Ground Floor, 6th Main, III Block, Bel lay, Vidyaranyapura"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674066600,"product":"DILTIAZEM HYDROCHLORIDE USP","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"88","totalValueFC":"192.7","currency":"EUR","unitRateINR":"7876","date":"19-Jan-2023","totalValueINR":"15752","totalValueInUsd":"192.7","indian_port":"AHMEDABAD AIR","hs_no":"29349990","bill_no":"4253131","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690741800,"product":"DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EP\/BP\/IP\/USP\/PH.EUR.)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"243.10","actualQuantity":"243.1","unit":"KGS","unitRateFc":"98","totalValueFC":"27174.8","currency":"EUR","unitRateINR":"9187.2","date":"31-Jul-2023","totalValueINR":"2233481.25","totalValueInUsd":"27174.8","indian_port":"AHMEDABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690741800,"product":"DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EP\/BP\/IP\/USP\/PH.EUR.)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"364.60","actualQuantity":"364.6","unit":"KGS","unitRateFc":"98","totalValueFC":"40756.6","currency":"EUR","unitRateINR":"9187.2","date":"31-Jul-2023","totalValueINR":"3349762.892","totalValueInUsd":"40756.6","indian_port":"AHMEDABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690741800,"product":"DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EP\/BP\/IP\/USP\/PH.EUR.)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"772.50","actualQuantity":"772.5","unit":"KGS","unitRateFc":"98","totalValueFC":"86353.4","currency":"EUR","unitRateINR":"9187.2","date":"31-Jul-2023","totalValueINR":"7097344.093","totalValueInUsd":"86353.4","indian_port":"AHMEDABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700850600,"product":"DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EP\/BP\/IP\/USP\/PH.EUR.)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.60","actualQuantity":"4.6","unit":"KGS","unitRateFc":"98","totalValueFC":"496.7","currency":"EUR","unitRateINR":"8991.5","date":"25-Nov-2023","totalValueINR":"41360.9","totalValueInUsd":"496.7","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"8944617","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE MILANO,26 36705 MONTECCHIO MAGGIORE ITALY, , ItalySDNF Italy","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"DILTIAZEM HYDROCHLORIDE API","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"XXODUXX","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"1654.00","actualQuantity":"1654","unit":"KGS","unitRateFc":"80","totalValueFC":"133768.9","currency":"USD","unitRateINR":"6710.6","date":"23-Feb-2024","totalValueINR":"11099310","totalValueInUsd":"133768.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1001243","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"N\/A","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"DILTIAZEM HYDROCHLORIDE API","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"XXODUXX","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"2027.00","actualQuantity":"2027","unit":"KGS","unitRateFc":"80","totalValueFC":"163979.7","currency":"USD","unitRateINR":"6712.4","date":"23-Feb-2024","totalValueINR":"13606012","totalValueInUsd":"163979.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1001243","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"N\/A","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717007400,"product":"DILTIAZEM HYDROCHLORIDE","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"2064.00","actualQuantity":"2064","unit":"KGS","unitRateFc":"95","totalValueFC":"198451.4","currency":"USD","unitRateINR":"8014.4","date":"30-May-2024","totalValueINR":"16541752","totalValueInUsd":"198451.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1003860","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717007400,"product":"DILTIAZEM HYDROCHLORIDE API","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"XXO DXXO","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"1885.00","actualQuantity":"1885","unit":"KGS","unitRateFc":"80","totalValueFC":"152607.7","currency":"USD","unitRateINR":"6748.3","date":"30-May-2024","totalValueINR":"12720488","totalValueInUsd":"152607.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1003856","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"N\/A","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"DILTIAZEM HYDROCHLORIDE USP LOT NO-2038406","address":"1\/5, SANTOSH COMPLEX, ARMUGAM","city":"BANGALORE , KARNATAKA","supplier":"SAGENT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"MAIVA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"3.85","actualQuantity":"3.85","unit":"KGS","unitRateFc":"980","totalValueFC":"3816.3","currency":"USD","unitRateINR":"82859","date":"22-Jul-2024","totalValueINR":"319007.15","totalValueInUsd":"3816.3","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"4646079","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"113, CONNCECTICUT COMPLEXPLATTSBURGH NY12903 US","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"DILTIAZEM HYDROCHLORIDE USP LOT NO-2038406","address":"1\/5, SANTOSH COMPLEX, ARMUGAM","city":"BANGALORE , KARNATAKA","supplier":"SAGENT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"MAIVA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"980","totalValueFC":"5947.5","currency":"USD","unitRateINR":"82859","date":"22-Jul-2024","totalValueINR":"497154","totalValueInUsd":"5947.5","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"4646079","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"113, CONNCECTICUT COMPLEXPLATTSBURGH NY12903 US","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"DILTIAZEM HYDROCHLORIDE USP LOT NO-2038406","address":"1\/5, SANTOSH COMPLEX, ARMUGAM","city":"BANGALORE , KARNATAKA","supplier":"SAGENT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"MAIVA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"10.45","actualQuantity":"10.45","unit":"KGS","unitRateFc":"980","totalValueFC":"10358.5","currency":"USD","unitRateINR":"82859","date":"22-Jul-2024","totalValueINR":"865876.55","totalValueInUsd":"10358.5","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"4646079","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"113, CONNCECTICUT COMPLEXPLATTSBURGH NY12903 US","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728325800,"product":"DILTIAZEM HYDROCHLORIDE 7133000 \/ BATCH NO.202405074011","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"F.I.S.-FABBRICA ITALIANA SINTETICI SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"1100.00","actualQuantity":"1100","unit":"KGS","unitRateFc":"95","totalValueFC":"105524.1","currency":"USD","unitRateINR":"8060.8","date":"08-Oct-2024","totalValueINR":"8866825","totalValueInUsd":"105524.1","indian_port":"Madras Air","hs_no":"29349990","bill_no":"6012215","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE MILANO 26 36075 MONTECCHIO MAGGIORE (VI) ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]
04-Jan-2021
30-Nov-2024
KGS
overview
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Average Price (USD/KGS)

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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FDF Dossiers

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01

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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : DILACOR XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-05-29

Application Number : 20092

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

02

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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : DILACOR XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-05-29

Application Number : 20092

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

03

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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : DILACOR XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1992-05-29

Application Number : 20092

Regulatory Info : DISCN

Registration Country : USA

Abbvie CB

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : DISCN

Registration Country : USA

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML

Packaging :

Approval Date : 1997-08-26

Application Number : 74894

Regulatory Info : DISCN

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG

Packaging :

Approval Date : 2022-05-05

Application Number : 215775

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 90MG

Packaging :

Approval Date : 2022-05-05

Application Number : 215775

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 120MG

Packaging :

Approval Date : 2022-05-05

Application Number : 215775

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

08

Duphat
Not Confirmed
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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : CARDIZEM LA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2003-02-06

Application Number : 21392

Regulatory Info : RX

Registration Country : USA

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09

Duphat
Not Confirmed
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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 360MG

Packaging :

Approval Date : 2006-09-12

Application Number : 76563

Regulatory Info : DISCN

Registration Country : USA

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10

Duphat
Not Confirmed
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Duphat
Not Confirmed

DILTIAZEM HYDROCHLORIDE

Brand Name : DILTIAZEM HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 90MG

Packaging :

Approval Date : 2022-09-23

Application Number : 216521

Regulatory Info : RX

Registration Country : USA

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 120MG

USFDA APPLICATION NUMBER - 18602

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DOSAGE - TABLET;ORAL - 30MG

USFDA APPLICATION NUMBER - 18602

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DOSAGE - TABLET;ORAL - 60MG

USFDA APPLICATION NUMBER - 18602

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DOSAGE - TABLET;ORAL - 90MG

USFDA APPLICATION NUMBER - 18602

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG

USFDA APPLICATION NUMBER - 20062

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG

USFDA APPLICATION NUMBER - 20062

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 20062

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

USFDA APPLICATION NUMBER - 20062

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG

USFDA APPLICATION NUMBER - 20062

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20092

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20092

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20092

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG

USFDA APPLICATION NUMBER - 20401

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG

USFDA APPLICATION NUMBER - 20401

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 20401

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

USFDA APPLICATION NUMBER - 20401

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG

USFDA APPLICATION NUMBER - 20401

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 420...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 420MG

USFDA APPLICATION NUMBER - 20401

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120MG

USFDA APPLICATION NUMBER - 21392

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG

USFDA APPLICATION NUMBER - 21392

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 21392

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG

USFDA APPLICATION NUMBER - 21392

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 360M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 360MG

USFDA APPLICATION NUMBER - 21392

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420MG

USFDA APPLICATION NUMBER - 21392

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ABOUT THIS PAGE

Diltiazem Hydrochloride Manufacturers

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

Diltiazem Hydrochloride Suppliers

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

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

Diltiazem Hydrochloride USDMF

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

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

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

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

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

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

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

Diltiazem Hydrochloride CEP

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

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

Diltiazem Hydrochloride WC

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

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

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

Finished drug products

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

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

Diltiazem Hydrochloride GMP

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

Diltiazem Hydrochloride CoA

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

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

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