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Chemistry

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Also known as: 54965-21-8, Albenza, Eskazole, Zentel, Valbazen, Proftril
Molecular Formula
C12H15N3O2S
Molecular Weight
265.33  g/mol
InChI Key
HXHWSAZORRCQMX-UHFFFAOYSA-N
FDA UNII
F4216019LN

Albendazole
A benzimidazole broad-spectrum anthelmintic structurally related to MEBENDAZOLE that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)
Albendazole is an Anthelmintic. The mechanism of action of albendazole is as a Cytochrome P450 1A Inducer.
1 2D Structure

Albendazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl N-(6-propylsulfanyl-1H-benzimidazol-2-yl)carbamate
2.1.2 InChI
InChI=1S/C12H15N3O2S/c1-3-6-18-8-4-5-9-10(7-8)14-11(13-9)15-12(16)17-2/h4-5,7H,3,6H2,1-2H3,(H2,13,14,15,16)
2.1.3 InChI Key
HXHWSAZORRCQMX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCSC1=CC2=C(C=C1)N=C(N2)NC(=O)OC
2.2 Other Identifiers
2.2.1 UNII
F4216019LN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Albendazole Monohydrochloride

2. Albendoral

3. Albenza

4. Andazol

5. Bendapar

6. Bilutac

7. Digezanol

8. Disthelm

9. Endoplus

10. Eskazole

11. Gascop

12. Lurdex

13. Mediamix V Disthelm

14. Metiazol

15. Monohydrochloride, Albendazole

16. Sk And F 62979

17. Sk And F-62979

18. Sk And F62979

19. Skf 62979

20. Skf-62979

21. Skf62979

22. Valbazen

23. Zentel

2.3.2 Depositor-Supplied Synonyms

1. 54965-21-8

2. Albenza

3. Eskazole

4. Zentel

5. Valbazen

6. Proftril

7. Albendazolum

8. Andazol

9. Sk&f 62979

10. Methyl 5-(propylthio)-2-benzimidazolecarbamate

11. Skf 62979

12. Sk&f-62979

13. 5-(propylthio)-2-carbomethoxyaminobenzimidazole

14. Skf-62979

15. Methyl N-[6-(propylsulfanyl)-1h-1,3-benzodiazol-2-yl]carbamate

16. Methyl N-(6-propylsulfanyl-1h-benzimidazol-2-yl)carbamate

17. (5-(propylthio)-1h-benzimidazol-2-yl)carbamic Acid Methyl Ester

18. O-methyl N-(5-(propylthio)-2-benzimidazolyl)carbamate

19. Nsc 220008

20. Carbamic Acid, [5-(propylthio)-1h-benzimidazol-2-yl]-, Methyl Ester

21. Carbamic Acid, (5-(propylthio)-1h-benzimidazol-2-yl)-, Methyl Ester

22. Albendazol

23. Bilutac

24. Nsc-220008

25. Chembl1483

26. Methyl [5-(propylsulfanyl)-1h-benzimidazol-2-yl]carbamate

27. Methyl [6-(propylsulfanyl)-1h-benzimidazol-2-yl]carbamate

28. ((propylthio)-5 1h-benzimidazolyl-2) Carbamate De Methyle

29. Chebi:16664

30. Zental

31. F4216019ln

32. Ncgc00016876-01

33. Cas-54965-21-8

34. Dsstox_cid_2563

35. Dsstox_rid_76632

36. Dsstox_gsid_22563

37. Albendazol [inn-spanish]

38. Albendazolum [inn-latin]

39. Methyl [5-(propylthio)-1h-benzimidazol-2-yl]carbamate

40. Methyl 5-(propylthio)-1h-benzo[d]imidazol-2-ylcarbamate

41. Methyl [5-(propylthio)benzimidazol-2-yl]carbamate

42. Methyl N-(5-propylsulfanyl-1h-benzimidazol-2-yl)carbamate

43. Methyl N-[5-(propylsulfanyl)-1h-1,3-benzodiazol-2-yl]carbamate

44. Methyl (nz)-n-(5-propylsulfanyl-1,3-dihydrobenzimidazol-2-ylidene)carbamate

45. Albenza (tn)

46. Hsdb 7444

47. Einecs 259-414-7

48. Mfcd00083232

49. Albendazole (jan/usp/inn)

50. Zenteltrade Mark

51. [5-(propylthio)benzimidazol-2-yl]carbamic Acid Methyl Ester

52. Albenzatrade Mark

53. Andazoltrade Mark

54. Unii-f4216019ln

55. Eskazoletrade Mark

56. Albendazole,(s)

57. ((propylthio)-5 1h-benzimidazolyl-2) Carbamate De Methyle [french]

58. Prestwick_675

59. Albendazole(albenza)

60. Albendazole (albenza)

61. Albendazole [usan:usp:inn:ban:jan]

62. Spectrum_001532

63. Cpd000036735

64. Albendazole [mi]

65. (5-propylsulfanyl-1h-benzoimidazol-2-yl)-carbamic Acid Methyl Ester

66. Prestwick0_000247

67. Prestwick1_000247

68. Prestwick2_000247

69. Prestwick3_000247

70. Spectrum4_000201

71. Spectrum5_001567

72. Albendazole [inn]

73. Albendazole [jan]

74. Chemdivam_000003

75. Chemdiv1_000190

76. Albendazole [hsdb]

77. Albendazole [usan]

78. Albendazole [vandf]

79. Albendazole [mart.]

80. Oprea1_429292

81. Oprea1_585016

82. Oprea1_640007

83. Schembl44682

84. Albendazole [usp-rs]

85. Albendazole [who-dd]

86. Albendazole [who-ip]

87. Bspbio_000034

88. Bspbio_002548

89. Kbiogr_000801

90. Kbioss_002012

91. Mls000069722

92. Albendazolum [who-ip]

93. Bidd:gt0615

94. Divk1c_000704

95. Spectrum1503903

96. Methoxy-n-(5-propylthiobenzimidazol-2-yl)carboxamide

97. Spbio_002253

98. Bpbio1_000038

99. Albendazole [green Book]

100. Dtxsid0022563

101. Hms502d06

102. Hms587i14

103. Hxhwsazorrcqmx-uhfffaoysa-

104. Kbio1_000704

105. Kbio2_002012

106. Kbio2_004580

107. Kbio2_007148

108. Albendazole [orange Book]

109. Ninds_000704

110. Albendazole [ep Monograph]

111. Hms1568b16

112. Hms1922k04

113. Hms2090g19

114. Hms2093k13

115. Hms2095b16

116. Hms2231o03

117. Hms3259b05

118. Hms3369c03

119. Hms3651c15

120. Hms3712b16

121. Pharmakon1600-01503903

122. Albendazole [usp Monograph]

123. [5-(propythio)-1h-benzimidazol-2-yl]carbamic Acid Methyl Ester

124. Bcp12108

125. Hy-b0223

126. Tox21_110659

127. Tox21_302300

128. Ac-015

129. Bbl005883

130. Bdbm50241293

131. Ccg-39620

132. Mfcd01220143

133. N-[6-(propylthio)-1h-benzimidazol-2-yl]carbamic Acid Methyl Ester

134. Nsc220008

135. Nsc758644

136. S1640

137. Stk387550

138. Stl046130

139. Zinc17146904

140. Akos000540882

141. Akos005431684

142. Akos005699352

143. Tox21_110659_1

144. Albendazole 100 Microg/ml In Methanol

145. Ccg-220247

146. Db00518

147. Ks-5159

148. Nc00615

149. Nsc-758644

150. Idi1_000704

151. Methyl [(2z)-5-(propylsulfanyl)-1,3-dihydro-2h-benzimidazol-2-ylidene]carbamate

152. Ncgc00016876-02

153. Ncgc00016876-03

154. Ncgc00016876-04

155. Ncgc00016876-05

156. Ncgc00016876-06

157. Ncgc00016876-07

158. Ncgc00016876-08

159. Ncgc00016876-09

160. Ncgc00016876-10

161. Ncgc00016876-12

162. Ncgc00022896-03

163. Ncgc00022896-04

164. Ncgc00022896-05

165. Ncgc00022896-06

166. Ncgc00022896-07

167. Ncgc00022896-08

168. Ncgc00255250-01

169. Albendazole, Analytical Standard, >=98%

170. Smr000036735

171. Albendazole 100 Microg/ml In Acetonitrile

172. Sbi-0051849.p002

173. Db-052669

174. Ab00052377

175. Ft-0621945

176. Sw196830-3

177. En300-49850

178. Methyl 5-propylthio-2-benzimidazole Carbamate

179. Vu0239747-6

180. Bim-0051849.0001

181. C01779

182. D00134

183. H10782

184. Ab00052377-13

185. Ab00052377-14

186. Ab00052377_15

187. Ab00052377_16

188. A830429

189. Albendazole, Antibiotic For Culture Media Use Only

190. Q411629

191. Sr-01000000171

192. Sr-05000001875

193. Methyl 5-(propylthio)-1h-benzimidazol-2-ylcarbamate

194. Q-200603

195. Q-200604

196. Sr-01000000171-2

197. Sr-05000001875-1

198. Brd-k79131256-001-04-7

199. Brd-k79131256-001-08-8

200. Methyl 5-(propylthio)benzimidazol-2-ylcarbamate

201. Methyl 6-(propylthio)-1h-benzo[d]imidazol-2-ylcarbamate

202. Z1245635850

203. 2-[(methoxycarbonyl)amino]-5-propylthio-1h-benzimidazole

204. Albendazole, European Pharmacopoeia (ep) Reference Standard

205. Methyl (6-(propylthio)-1h-benzo[d]imidazol-2-yl)carbamate

206. Methyl 5-(propylsulfanyl)-1h-benzimidazol-2-ylcarbamate #

207. Albendazole, United States Pharmacopeia (usp) Reference Standard

208. Methyl N-(5-(propylthio)-1h-benzimidazol-2-yl)carbamate

209. Albendazole, Pharmaceutical Secondary Standard; Certified Reference Material

210. Carbamic Acid, N-[5-(propylthio)-1h-benzimidazol-2-yl]-,?methyl Ester

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 265.33 g/mol
Molecular Formula C12H15N3O2S
XLogP32.9
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass265.08849790 g/mol
Monoisotopic Mass265.08849790 g/mol
Topological Polar Surface Area92.3 Ų
Heavy Atom Count18
Formal Charge0
Complexity291
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 2  
Drug NameAlbenza
PubMed HealthAlbendazole (By mouth)
Drug ClassesAnthelmintic
Drug LabelALBENZA (albendazole) is an orally administered broad-spectrum anthelmintic. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structu...
Active IngredientAlbendazole
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyAmedra Pharms

2 of 2  
Drug NameAlbenza
PubMed HealthAlbendazole (By mouth)
Drug ClassesAnthelmintic
Drug LabelALBENZA (albendazole) is an orally administered broad-spectrum anthelmintic. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structu...
Active IngredientAlbendazole
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyAmedra Pharms

4.2 Therapeutic Uses

Mesh Headings: anthelmintics, anticestodalagents, antiprotozoal agents

National Library of Medicine, SIS; ChemIDplus Record for Albendazole (54965-21-8). Available from, as of April 13, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp


Albendazole is a benzimidazole carbamate, used for the treatment of gastrointestinal infestations with roundworms, lungworms and tapeworms and adult flukes of Fasciola hepatica.

European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines Evaluation Unit, Committee for Veterinary Medicinal Products; Albendazole, Summary Report(3). EMEA/MRL/865/03-Final (June 2004). Available from, as of July 25, 2006: https://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/document_library_search.jsp&murl=menus/document_library/document_library.jsp&mid


Certain microsporidial species that cause intestinal infections in people with AIDS respond partially (Enterocytozoon bieneusi) or completely (Encephalitozoon intestintalis and related Encephalitozoon species) to albendazole; albendazole's sulfoxide metabolite appears to be especially effective against these parasites in vitro.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1126


MEDICATION: ...Used against nematode infections: Ascaris, Necator, Ancylostoma, Trichuris, Enterobius, and systemic nematodes such as Trichinella spiralis, Gnathostoma spinigerum, and larval Angiostrongylus cantonensis. In addition it is used against the larval stages of the cestodes Echinococcus granulosus and E. multilocularis and for treatment of neurocysticercosis caused by Taenia solium.

Ullmann's Encyclopedia of Industrial Chemistry. 6th ed.Vol 1: Federal Republic of Germany: Wiley-VCH Verlag GmbH & Co. 2003 to Present, p. V. 3 185 (2003)


For more Therapeutic Uses (Complete) data for ALBENDAZOLE (21 total), please visit the HSDB record page.


4.3 Drug Warning

Leukopenia has occurred in less than 1% of patients receiving albendazole, and rarely, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia have been reported. Therefore, blood counts should be performed at the start of, and every 2 weeks during, each 28-day treatment cycle. The manufacturer states that if decreases in the total leukocyte count occur, treatment with albendazole may be continued if the decreases are modest and do not progress.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 46


Because albendazole has been associated with mild to moderate increases of hepatic enzymes in about 16% of patients receiving the drug in clinical trials, and may cause hepatotoxicity, liver function tests should be performed prior to each course of albendazole therapy and at least every 2 weeks during treatment with the drug. If clinically important increases in liver function test results occur, albendazole should be discontinued. The drug can be reinstituted when liver enzymes return to pretreatment levels, but laboratory tests should be performed frequently during repeat therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 46


Albendazole may cause harm to the fetus and should be used during pregnancy only if the benefits justify the risk to the fetus and only in clinical circumstances where no alternative management is appropriate. Women of childbearing age should begin treatment only after a negative pregnancy test, and should be cautioned against becoming pregnant while receiving albendazole or within 1 month of completing treatment with the drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 46


Teratogenic in animals (rats and rabbits) and is not recommended in pregnancy or in infants younger than 2 years.

Haddad, L.M. (Ed). Clinical Management of Poisoning and Drug Overdose 3rd Edition. Saunders, Philadelphia, PA. 1998., p. 714


For more Drug Warnings (Complete) data for ALBENDAZOLE (9 total), please visit the HSDB record page.


4.4 Drug Indication

For the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium and for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Albendazole is a broad-spectrum anthelmintic. The principal mode of action for albendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules.


5.2 MeSH Pharmacological Classification

Anthelmintics

Agents that kill parasitic worms. They are used therapeutically in the treatment of HELMINTHIASIS in man and animal. (See all compounds classified as Anthelmintics.)


Anticestodal Agents

Agents used to treat tapeworm infestations in man or animals. (See all compounds classified as Anticestodal Agents.)


Tubulin Modulators

Agents that interact with TUBULIN to inhibit or promote polymerization of MICROTUBULES. (See all compounds classified as Tubulin Modulators.)


Antiprotozoal Agents

Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ALBENDAZOLE
5.3.2 FDA UNII
F4216019LN
5.3.3 Pharmacological Classes
Cytochrome P450 1A Inducers [MoA]; Anthelmintic [EPC]
5.4 ATC Code

P - Antiparasitic products, insecticides and repellents

P02 - Anthelmintics

P02C - Antinematodal agents

P02CA - Benzimidazole derivatives

P02CA03 - Albendazole


5.5 Absorption, Distribution and Excretion

Absorption

Poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Oral bioavailability appears to be enhanced when coadministered with a fatty meal (estimated fat content 40 g)


Route of Elimination

Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma.


Albendazole is variably and erractically absorbed after oral admin; absorption is enhanced by the presence of fatty foods and possibly by bile salts as well. After a 400-mg oral dose, albendazole cannot be detected in plasma, because the drug is rapidly metabolized in the liver and possibly in the intestine as well, to albendazole sulfoxide, which has potent anthelmintic activity. Both the (+) and (-) enantiomers of albendazole sulfoxide are formed, but in human beings the (+) enantiomer reaches much higher peak concn in plasma and is cleared much more slowly than the (-) form. Total sulfoxide attains peak plasma concn of about 300 ng/mL, but with wide interindividual variation. Albendazole sulfoxide is about 70% bound to plasma proteins ... It is well distributed into various tissues, including hydatid cysts, where it reaches a concn of about one-fifth that in plasma ... Both sulfoxide derivatives are oxidized further to the nonchiral sulfone metabolite of albendazole, which is pharmacologically inactive; this reaction favors the (-) sulfoxide and probably becomes rate limiting in determining the clearance ... Albendazole metabolites are excreted mainly in the urine.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1126


Oral bioavailability of albendazole appears to be increased when the drug is administered with a fatty meal; when the drug is administered with meals containing about 40 g of fat, plasma concentrations of albendazole sulfoxide are up to 5 times higher than those observed when the drug is administered to fasting patients

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 46


Sheep bearing permanent ruminal and abomasal cannulae were given a single oral dose of 10 mg/kg bw albendazole as a 2.5% formulation. Albendazole was absorbed unchanged from the rumen. Once in the body it was rapidly degraded, and sulfone metabolites were detected in plasma, the former achieving the greater level. All 3 compounds were present in the abomasum. Presumably albendazole was passed through the stomachs while the metabolites were secreted or diffused into this organ. Non-detectable levels of all 3 compounds were reached in plasma and rumen at 96 hr and in abomasum at 120 hr.

Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additive Series 25: Toxicological Evaluation of Ceratin Veterinary Drug Residues in Food: Albendazole (1990). Available from, as of July 17, 2006: https://www.inchem.org/documents/jecfa/jecmono/v25je01.htm


The parent compound was virtually undetectable in the plasma of Sprague Dawley males and females given a single gavage dose of 10.6 mg/kg bw albendazole in an aqueous suspension. Rapid metabolism let to the appearance of the sulfoxide and subsequently the sulfone derivatives in plasma. Both metabolites decreased to very low levels at 18 hr. Daily dosing at 10.6 mg/kg bw in males for a period of 10 days resulted in lower plasma levels of sulfoxide and higher levels of the sulfone. Albendazole induces certain hepatic drug-metabolising enzymes, which may be responsible for enhancing the degradation of sulfoxide to sulfone following repeated administration.

Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additive Series 25: Toxicological Evaluation of Ceratin Veterinary Drug Residues in Food: Albendazole (1990). Available from, as of July 17, 2006: https://www.inchem.org/documents/jecfa/jecmono/v25je01.htm


For more Absorption, Distribution and Excretion (Complete) data for ALBENDAZOLE (9 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Hepatic. Rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine.


Albendazole is converted first to a sulfoxide and then to a sulfone. All of these reactions are catalyzed by flavin monooxygenases (FMO) and/or cytochrome P450. Both enzymes are efficient catalysts of S-oxygenation ...

Klaassen, C.D. (ed). Casarett and Doull's Toxicology. The Basic Science of Poisons. 6th ed. New York, NY: McGraw-Hill, 2001., p. 176


Albendazole is metabolized in the liver to an active metabolite, albendazole sulfoxide, which accounts for detectable plasma concentrations of the drug; systemic anthelmintic activity of the drug has been attributed to this metabolite.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 47


Albendazole ... is rapidly metabolized in the liver and possibly in the intestine as well, to albendazole sulfoxide, which has potent anthelmintic activity. Both the (+) and (-) enantiomers of albendazole sulfoxide are formed, but in human beings the (+) enantiomer reaches much higher peak concn in plasma and is cleared much more slowly than the (-) form. Total sulfoxide attains peak plasma concn of about 300 ng/mL, but with wide interindividual variation. Albendazole sulfoxide is about 70% bound to plasma proteins and has a highly variable plasma half-life ranging from about 4 to 15 hr. It is well distributed into various tissues, including hydatid cysts, where it reaches a concn of about one-fifth that in plasma. This probably explains why albendazole is more effective than mebendazole for treating hydatid cyst disease. Formation of albendazole sulfoxide is catalyzed by both microsomal flavin monooxygenase and isoforms of cytochrome P450 in the liver and possibly also in the intestine. Hepatic flavin monooxygenase activity appears associated with (+) albendazole sulfoxide formation, whereas cytochromes P450 preferentially produce the (-) sulfoxide metabolite. Both sulfoxide derivatives are oxidized further to the nonchiral sulfone metabolite of albendazole, which is pharmacologically inactive; this reaction favors the (-) sulfoxide and probably becomes rate limiting in determining the clearance and plasma half-life of the bioactive (+) sulfoxide metabolite. Induction of enzymes involved in sulfone formation from the (+) sulfoxide could account for some of the wide variation noted in plasma half-lives of albendazole sulfoxide. Indeed, in animal models, benzimidazoles can induce their own metabolism. Albendazole metabolites are excreted mainly in the urine.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1126


Sheep bearing permanent ruminal and abomasal cannulae were given a single oral dose of 10 mg/kg bw albendazole as a 2.5% formulation. Albendazole was absorbed unchanged from the rumen. Once in the body it was rapidly degraded, and sulfone metabolites were detected in plasma, the former achieving the greater level. All 3 compounds were present in the abomasum. Presumably albendazole was passed through the stomachs while the metabolites were secreted or diffused into this organ. Non-detectable levels of all 3 compounds were reached in plasma and rumen at 96 hr and in abomasum at 120 hr.

Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additive Series 25: Toxicological Evaluation of Ceratin Veterinary Drug Residues in Food: Albendazole (1990). Available from, as of July 17, 2006: https://www.inchem.org/documents/jecfa/jecmono/v25je01.htm


For more Metabolism/Metabolites (Complete) data for ALBENDAZOLE (12 total), please visit the HSDB record page.


Albendazole has known human metabolites that include Albendazole oxide.

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


5.7 Biological Half-Life

Terminal elimination half-life ranges from 8 to 12 hours (single dose, 400mg).


Albendazole ... is rapidly metabolized ... to albendazole sulfoxide, which ... has a highly variable plasma half-life ranging from about 4 to 15 hr ... Both /(+) and (-)/ sulfoxide derivatives are oxidized further to the nonchiral sulfone metabolite ... This reaction favors the (-) sulfoxide and probably becomes rate limiting in determining ... plasma half-life of the bioactive (+) sulfoxide metabolite. Induction of enzymes involved in sulfone formation from the (+) sulfoxide could account for some of the wide variation noted in plasma half-lives of albendazole sulfoxide.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1126


5.8 Mechanism of Action

Albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by diminishing its energy production, ultimately leading to immobilization and death of the parasite. It works by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. As cytoplasmic microtubules are critical in promoting glucose uptake in larval and adult stages of the susceptible parasites, the glycogen stores of the parasites are depleted. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth.


Benzimidazoles produce many biochemical changes in susceptible nematodes, eg, inhibition of mitochondrial fumarate reductase, reduced glucose transport, and uncoupling of oxidative phosphorylation ... /but/ the primary action ... /should be/ to inhibit microtubule polymerization by binding to beta-tubulin. The selective toxicity of these agents derives from the fact that specific, high-affinity binding to parasite beta-tubulin occurs at much lower concn than does binding to the mammalian protein ... Benzimidazole-resistant Haemonchus contortus display reduced high-affinity drug binding to beta-tubulin and alterations in beta-tubulin isotype gene expression that correlate with drug resistance ... Two identified mechanisms of drug resistance in nematodes involve both a progressive loss of "susceptible" beta-tubulin gene isotypes together with emergence of a "resistant" isotype with a conserved point mutation that encodes a tyrosine instead of phenylalanine at position 200 of beta-tubulin. While this mutation may not be required for benzimidazole resistance in all parasites, eg, Giardia lamblia, benzimidazole resistance in parasitic nematodes is unlikely to be overcome by novel benzimidazole analogs, because tyrosine also is present at position 200 of human beta-tubulin. /Benzimidazoles/

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1126


Although the exact mechanism of action of albendazole has not been fully elucidated, the principal anthelmintic effect of benzimidazoles, including albendazole, appears to be the specific, high-affinity binding of the drug to free beta-tubulin in parasite cells, resulting in selective inhibition of parasite microtubule polymerization, and inhibition of microtubule-dependent uptake of glucose. Benzimidazole drugs bind to the beta-tubulin of parasites at much lower concentrations than to mammalian beta-tubulin protein; the drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 47


The mode of action of albendazole is by binding strongly with the tubulin in the cells of nematodes. The intestinal cells of the nematode are particularly affected, resulting in a loss of absorptive function which causes the nematodes to starve to death.

European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines Evaluation Unit, Committee for Veterinary Medicinal Products; Albendazole, Summary Report(3). EMEA/MRL/865/03-Final (June 2004). Available from, as of July 25, 2006: https://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/document_library_search.jsp&murl=menus/document_library/document_library.jsp&mid


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Emay Pharmaceuticals

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Octavius Pharma Pvt. Ltd

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UQUIFA

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About the Company : Emay Pharmaceuticals Pvt Ltd functions as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. As a GMP-approved API manufacturing company, we boast over three decades...

Emay Pharmaceuticals Pvt Ltd functions as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. As a GMP-approved API manufacturing company, we boast over three decades of experience in exporting a wide array of Pharmaceutical and allied products, engaging in both manufacturing and export operations. Emay Pharmaceuticals Pvt Ltd comprises a team of seasoned professionals with extensive expertise in Human Health APIs and Veterinary Health APIs. Specializing in the trade of various raw materials for both Human and Veterinary medicine, Emay Pharmaceuticals Pvt Ltd is dedicated to providing quality products.
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LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Albendazole

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
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Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
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About the Company : Atman Pharma Private Limited is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and ove...

Atman Pharma Private Limited is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. With a heritage spanning over 33 years and vast experience, we have earned a reputation for delivering high-quality and abundant services within the industry. Our emergence as prominent solution providers in the pharmaceutical business underscores our commitment to excellence.
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About the Company : Formil QuImica Ltd is a Brazilian company located in BaruerI - SP. We produce through chemical synthesis or extraction and commercialize API (Active Pharmaceutical Ingredient) on l...

Formil QuImica Ltd is a Brazilian company located in BaruerI - SP. We produce through chemical synthesis or extraction and commercialize API (Active Pharmaceutical Ingredient) on local and external markets focused on Pharmaceuticals, Veterinary and Cosmetic companies. Our expertise is based in constant innovation research, driven through our R&D that works independently and with cooperation with Universities, Research Centers and also with customer's partnership. Formil produces under rigorous GMP procedures that can guarantee the quality and reliability of our product, processes and services.
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About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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05-Jan-2022
30-Apr-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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FDF Dossiers

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01

Albendazole

Brand Name : Eskazole

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Albendazole

Brand Name : Zentel

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Albendazole

Brand Name : Zentel

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

ALBENDAZOLE

Brand Name : ALBENDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2021-01-26

Application Number : 211034

Regulatory Info : RX

Registration Country : USA

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05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Albendazole

Brand Name : Albendazole

Dosage Form : DC Granules

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Regulatory Info :

Registration Country : India

Albendazole

Brand Name : Albendazole

Dosage Form : DC Granules

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Albendazole

Brand Name : Albendazole

Dosage Form : Tablet

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Regulatory Info : DISCN

Registration Country : USA

ALBENDAZOLE

Brand Name : ALBENDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2018-12-07

Application Number : 210011

Regulatory Info : DISCN

Registration Country : USA

Strides Pharma Science

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Regulatory Info :

Registration Country : India

Albendazole

Brand Name : Albendazole

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

10

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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Regulatory Info : Generic

Registration Country : India

Albendazole

Brand Name : Alzol

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

BalPharma
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ABOUT THIS PAGE

Looking for 54965-21-8 / Albendazole API manufacturers, exporters & distributors?

Albendazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Albendazole

Synonyms

54965-21-8, Albenza, Eskazole, Zentel, Valbazen, Proftril

Cas Number

54965-21-8

Unique Ingredient Identifier (UNII)

F4216019LN

About Albendazole

A benzimidazole broad-spectrum anthelmintic structurally related to MEBENDAZOLE that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)

Albendazole Pfizer Brand Manufacturers

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

Albendazole Pfizer Brand Suppliers

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

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

Albendazole Pfizer Brand USDMF

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

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

click here to find a list of Albendazole Pfizer Brand suppliers with USDMF on PharmaCompass.

Albendazole Pfizer Brand CEP

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

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

Albendazole Pfizer Brand WC

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

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

Albendazole Pfizer Brand 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 Albendazole Pfizer Brand as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Albendazole Pfizer Brand suppliers with NDC on PharmaCompass.

Albendazole Pfizer Brand GMP

Albendazole Pfizer Brand 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 Albendazole Pfizer Brand 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 Albendazole Pfizer Brand GMP manufacturer or Albendazole Pfizer Brand GMP API supplier for your needs.

Albendazole Pfizer Brand CoA

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

Albendazole Pfizer Brand CoA mostly includes findings from lab analyses of a specific batch. For each Albendazole Pfizer Brand 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.

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