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Also known as: Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax
Molecular Formula
C38H72N2O12
Molecular Weight
749.0  g/mol
InChI Key
MQTOSJVFKKJCRP-BICOPXKESA-N
FDA UNII
J2KLZ20U1M

Azithromycin
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
Azithromycin anhydrous is a Macrolide Antimicrobial.
1 2D Structure

Azithromycin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
2.1.2 InChI
InChI=1S/C38H72N2O12/c1-15-27-38(10,46)31(42)24(6)40(13)19-20(2)17-36(8,45)33(52-35-29(41)26(39(11)12)16-21(3)48-35)22(4)30(23(5)34(44)50-27)51-28-18-37(9,47-14)32(43)25(7)49-28/h20-33,35,41-43,45-46H,15-19H2,1-14H3/t20-,21-,22+,23-,24-,25+,26+,27-,28+,29-,30+,31-,32+,33-,35+,36-,37-,38-/m1/s1
2.1.3 InChI Key
MQTOSJVFKKJCRP-BICOPXKESA-N
2.1.4 Canonical SMILES
CCC1C(C(C(N(CC(CC(C(C(C(C(C(=O)O1)C)OC2CC(C(C(O2)C)O)(C)OC)C)OC3C(C(CC(O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O
2.1.5 Isomeric SMILES
CC[C@@H]1[C@@]([C@@H]([C@H](N(C[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O
2.2 Other Identifiers
2.2.1 UNII
J2KLZ20U1M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Azadose

2. Azithromycin Dihydrate

3. Azithromycin Monohydrate

4. Azitrocin

5. Azythromycin

6. Cp 62993

7. Cp-62993

8. Cp62993

9. Dihydrate, Azithromycin

10. Goxal

11. Monohydrate, Azithromycin

12. Sumamed

13. Toraseptol

14. Ultreon

15. Vinzam

16. Zentavion

17. Zithromax

18. Zitromax

2.3.2 Depositor-Supplied Synonyms

1. Zithromax

2. 83905-01-5

3. Sumamed

4. Hemomycin

5. Azasite

6. Zitromax

7. Zmax

8. Azithromycine

9. Azithromycinum

10. Azenil

11. Aziromycin

12. Zithromac

13. Azithromycine [french]

14. Azithromycinum [latin]

15. Azithromycin Dihydrate

16. Cp 62993

17. Cp-62993

18. Azitromax

19. Misultina

20. Tromix

21. Azithromycin Anhydrous

22. Azithrocin

23. Aruzilina

24. Macrozit

25. Trozocina

26. Xithrone

27. Zythromax

28. Aziwin

29. Durasite

30. Xz-450

31. Toraseptol

32. Anhydrous Azithromycin

33. 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A

34. J2klz20u1m

35. Chebi:2955

36. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-(((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

37. Azitrocin

38. Xz 405

39. Xz 450

40. Nsc-758625

41. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

42. Ncgc00090753-01

43. Aritromicina

44. Mixoterin

45. Zithrax

46. Zitrotek

47. Aziwok

48. Aztrin

49. Setron

50. Zitrim

51. Tobil

52. Zifin

53. Cp-62,993

54. Zeto

55. Zmas

56. Zithromax Iv

57. Dsstox_cid_10760

58. Dsstox_rid_78858

59. Dsstox_gsid_30760

60. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranoside

61. Z-pak

62. C38h72n2o12

63. Aritromicina [spanish]

64. Azitromicine

65. Azithromycin (as Dihydrate)

66. Trulimax

67. Zentavion

68. Drg-0104

69. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-{[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-2-ethyl-3,4,10-trihydroxy-13-{[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

70. 13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-?-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one

71. Azm

72. Smr000471864

73. Zit

74. Azithromycin (zithromax)

75. Cas-83905-01-5

76. Ccris 1961

77. Azithromycin [inn]

78. Hsdb 7205

79. Z-pak (azithromycin)

80. Azithromycin (anhydrous)

81. Sr-05000002067

82. Azithromycin, Antibiotic For Culture Media Use Only

83. Unii-j2klz20u1m

84. Brn 5387583

85. Azithramycine

86. Azitromicina

87. Zithromycin

88. Azifast

89. Azigram

90. Azimakrol

91. Azitromin

92. Azyter

93. Azithromycin [usan:inn:ban]

94. Nsc643732

95. Azithromycin (aids Initiative)

96. Azithromycin,(s)

97. Zmax Sr

98. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6

99. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-b-d-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-c-methyl-3-o-methyl-a-l-ribo-hexopyranoside

100. Zitromax Avium 600

101. Azitromicina [spanish]

102. Spectrum_000307

103. Azithromycin, Unspecified

104. Dch3

105. Spectrum2_001582

106. Spectrum3_000653

107. Spectrum4_000186

108. Spectrum5_001867

109. Azithromycin [mi]

110. Chembl529

111. Azithromycin [hsdb]

112. Ec 617-500-5

113. Schembl23481

114. Bspbio_002285

115. Kbiogr_000731

116. Kbioss_000787

117. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-1-oxa-6-azacyclopentadecan-15-one

118. 1-oxa-6-azacyclopentadecan-15-one, 13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-, (2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*))-

119. Mls001055353

120. Mls001066331

121. Mls001201763

122. Mls001304005

123. Mls001332499

124. Mls001332500

125. Azithromycin [who-dd]

126. Azithromycin, Unspecified Form

127. Bidd:gt0792

128. Divk1c_000233

129. Spectrum1503679

130. N-methyl-11-aza-10-deoxo-10-dihydroerythromycin A

131. Spbio_001544

132. Gtpl6510

133. Dtxsid8030760

134. Azithromycin, Analytical Standard

135. Hms500l15

136. Kbio1_000233

137. Kbio2_000787

138. Kbio2_003355

139. Kbio2_005923

140. Kbio3_001505

141. Ninds_000233

142. Hms1922g12

143. Hms2094m11

144. Hms2232m10

145. Hms3259d10

146. Act03224

147. Azithromycin [usp Monograph]

148. Tox21_111008

149. Tox21_201011

150. Bdbm50373918

151. Ccg-39360

152. Mfcd00873574

153. Zinc85537026

154. Akos015895044

155. Db00207

156. Nc00712

157. Nsc 758625

158. Azithromycin 100 Microg/ml In Methanol

159. Idi1_000233

160. Ncgc00090753-02

161. Ncgc00090753-03

162. Ncgc00090753-04

163. Ncgc00090753-06

164. Ncgc00258564-01

165. Ac-16014

166. Cp62,993

167. Hy-17506

168. Sbi-0206706.p001

169. Cp-62993-3

170. A-9940

171. A-9941

172. N46072

173. Ab00698251-10

174. Ab00698251_11

175. 905a015

176. A905251

177. Q165399

178. Sr-05000002067-1

179. Sr-05000002067-2

180. Brd-k74501079-001-18-1

181. Z1563146014

182. Azithromycin, European Pharmacopoeia (ep) Reference Standard

183. Azithromycin Identity, United States Pharmacopeia (usp) Reference Standard

184. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-((2s,3r,4s,6r)-

185. Azithromycin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

186. Azithromycin For System Suitability, European Pharmacopoeia (ep) Reference Standard

187. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-13-((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yloxy)-3,5,6,8,10,12,14-heptamethy...

188. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

189. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

190. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-1-oxa-6-azacyclopentadecan-15-one

191. [2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*)]-13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-.alpha.-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-

192. 13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 749.0 g/mol
Molecular Formula C38H72N2O12
XLogP34
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count14
Rotatable Bond Count7
Exact Mass748.50852574 g/mol
Monoisotopic Mass748.50852574 g/mol
Topological Polar Surface Area180 Ų
Heavy Atom Count52
Formal Charge0
Complexity1150
Isotope Atom Count0
Defined Atom Stereocenter Count18
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 8  
Drug NameAzasite
Drug LabelAzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of...
Active IngredientAzithromycin
Dosage FormSolution/drops
RouteOphthalmic
Strength1%
Market StatusPrescription
CompanyOak Pharms Akorn

2 of 8  
Drug NameAzithromycin
PubMed HealthAzithromycin (Into the eye)
Drug ClassesAntibiotic
Drug LabelAzithromycin tablets and azithromycin for oral suspension contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-1...
Active IngredientAzithromycin
Dosage FormInjectable; Tablet; Solution; For suspension
Routeophthalmic; Injection; Oral
Strength1%; eq 600mg base; eq 500mg base; eq 500mg base/vial; eq 100mg base/5ml; eq 250mg base; eq 200mg base/5ml
Market StatusTentative Approval; Prescription
CompanyWockhardt; Sagent Strides; Teva Pharms; Fresenius Kabi Usa; Hospira; Gland Pharma; Teva; Apotex; Sun Pharm Inds; Pliva; Sandoz; Mylan

3 of 8  
Drug NameZithromax
PubMed HealthAzithromycin (By mouth)
Drug ClassesAntibiotic
Drug LabelZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12...
Active IngredientAzithromycin
Dosage FormTablet; Injectable; For suspension
RouteInjection; Oral
Strengtheq 500mg base; eq 100mg base/5ml; eq 250mg base; eq 1gm base/packet; eq 200mg base/5ml; eq 600mg base; eq 500mg base/vial
Market StatusPrescription
CompanyPfizer

4 of 8  
Drug NameZmax
PubMed HealthAzithromycin
Drug ClassesAntibiotic
Drug LabelZmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)...
Active IngredientAzithromycin
Dosage FormFor suspension, extended release
RouteOral
Strengtheq 2gm base/bot
Market StatusPrescription
CompanyPf Prism Cv

5 of 8  
Drug NameAzasite
Drug LabelAzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of...
Active IngredientAzithromycin
Dosage FormSolution/drops
RouteOphthalmic
Strength1%
Market StatusPrescription
CompanyOak Pharms Akorn

6 of 8  
Drug NameAzithromycin
PubMed HealthAzithromycin (Into the eye)
Drug ClassesAntibiotic
Drug LabelAzithromycin tablets and azithromycin for oral suspension contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-1...
Active IngredientAzithromycin
Dosage FormInjectable; Tablet; Solution; For suspension
Routeophthalmic; Injection; Oral
Strength1%; eq 600mg base; eq 500mg base; eq 500mg base/vial; eq 100mg base/5ml; eq 250mg base; eq 200mg base/5ml
Market StatusTentative Approval; Prescription
CompanyWockhardt; Sagent Strides; Teva Pharms; Fresenius Kabi Usa; Hospira; Gland Pharma; Teva; Apotex; Sun Pharm Inds; Pliva; Sandoz; Mylan

7 of 8  
Drug NameZithromax
PubMed HealthAzithromycin (By mouth)
Drug ClassesAntibiotic
Drug LabelZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12...
Active IngredientAzithromycin
Dosage FormTablet; Injectable; For suspension
RouteInjection; Oral
Strengtheq 500mg base; eq 100mg base/5ml; eq 250mg base; eq 1gm base/packet; eq 200mg base/5ml; eq 600mg base; eq 500mg base/vial
Market StatusPrescription
CompanyPfizer

8 of 8  
Drug NameZmax
PubMed HealthAzithromycin
Drug ClassesAntibiotic
Drug LabelZmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)...
Active IngredientAzithromycin
Dosage FormFor suspension, extended release
RouteOral
Strengtheq 2gm base/bot
Market StatusPrescription
CompanyPf Prism Cv

4.2 Therapeutic Uses

Anti-Bacterial Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 2012)


Azithromycin is used orally in children for the treatment of acute otitis media (AOM) caused by Haemophilus influenzae, M. catarrhalis, or S. pneumoniae. /Included in US product labeling/

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 225


Azithromycin is used orally for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci) in adults and children when first-line therapy (penicillins) cannot be used. /Included in US product labeling/

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 225


Although further study is needed, azithromycin has been used in conjunction with an antimalarial agent (e.g., chloroquine, quinine, artesunate [not commercially available in the US]) for the treatment of uncomplicated malaria caused by Plasmodium falciparum, including multidrug-resistant strains. Azithromycin should not be used alone as monotherapy for the treatment of malaria. /NOT included in US product labeling/

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 229


For more Therapeutic Uses (Complete) data for AZITHROMYCIN (52 total), please visit the HSDB record page.


4.3 Drug Warning

Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure; patients on drugs known to prolong the QT interval; or patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

US FDA; Label Information for ZITHROMAX (azithromycin tablets) and (azithromycin for oral suspension) (Last updated January 2013). Available from, as of March 15, 2013: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf


Pregnancy risk category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absents of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 2684


The most frequent adverse effects of azithromycin involve the GI tract (i.e., diarrhea/loose stools, nausea, abdominal pain). While these adverse effects generally are mild to moderate in severity and occur less frequently than with oral erythromycin, adverse GI effects are the most frequent reason for discontinuing azithromycin therapy. Administration of conventional azithromycin tablets or oral suspension with food may improve GI tolerability.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 234


Azithromycin has been detected in human milk. The drug should be used with caution in nursing women.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 237


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


4.4 Drug Indication

Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin. Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below. Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections. Refer to the FDA label and "Indications" section of this drug entry for detailed information. **Adults**: Acute bacterial exacerbations of chronic obstructive pulmonary disease due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Acute bacterial sinusitis due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated skin and skin structure infections due to _Staphylococcus aureus_, _Streptococcus pyogenes_, or _Streptococcus agalactiae_. Abscesses usually require surgical drainage. Urethritis and cervicitis due to _Chlamydia trachomatis_ or _Neisseria gonorrhoeae_. Genital ulcer disease in men due to _Haemophilus ducreyi_ (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. **Pediatric Patients** Acute otitis media caused by _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy. Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy.


Treatment of bacterial conjunctivitis


Prevention of bronchopulmonary dysplasia


5 Pharmacology and Biochemistry
5.1 Pharmacology

Macrolides stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections. Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose.


5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
AZITHROMYCIN ANHYDROUS
5.3.2 FDA UNII
J2KLZ20U1M
5.3.3 Pharmacological Classes
Macrolides [CS]; Macrolide Antimicrobial [EPC]
5.4 ATC Code

J01FA10

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


J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01F - Macrolides, lincosamides and streptogramins

J01FA - Macrolides

J01FA10 - Azithromycin


S - Sensory organs

S01 - Ophthalmologicals

S01A - Antiinfectives

S01AA - Antibiotics

S01AA26 - Azithromycin


5.5 Absorption, Distribution and Excretion

Absorption

Bioavailability of azithromycin is 37% following oral administration. Absorption is not affected by food. Macrolide absorption in the intestines is believed to be mediated by P-glycoprotein (ABCB1) efflux transporters, which are known to be encoded by the _ABCB1_ gene.


Route of Elimination

Biliary excretion of azithromycin, primarily as unchanged drug, is a major route of elimination. Over a 1 week period, approximately 6% of the administered dose is found as unchanged drug in urine.


Volume of Distribution

After oral administration, azithromycin is widely distributed in tissues with an apparent steady-state volume of distribution of 31.1 L/kg. Significantly greater azithromycin concentrations have been measured in the tissues rather than in plasma or serum,. The lung, tonsils and prostate are organs have shown a particularly high rate of azithromycin uptake. This drug is concentrated within macrophages and polymorphonucleocytes, allowing for effective activity against Chlamydia trachomatis. In addition, azithromycin is found to be concentrated in phagocytes and fibroblasts, shown by in vitro incubation techniques. In vivo studies demonstrate that concentration in phagocytes may contribute to azithromycin distribution to inflamed tissues.


Clearance

Mean apparent plasma cl=630 mL/min (following single 500 mg oral and i.v. dose)


Biliary excretion of azithromycin, predominantly as unchanged drug is a major route of elimination following oral administration.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241


Azithromycin is rapidly absorbed from the GI tract after oral administration; absorption of the drug is incomplete but exceeds that of erythromycin. The absolute oral bioavailability of azithromycin is reported to be approximately 34-52% with single doses of 500 mg to 1.2 g administered as various oral dosage forms. Limited evidence indicates that the low bioavailability of zithromycin results from incomplete GI absorption rather acid degradation of the drug or extensive first-pss metabolism.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 240


Azithromycin appears to be distributed into most body tissues and fluids after oral or IV administration. The extensive tissue uptake of azithromycin has been attributed to cellular uptake of this basic antibiotic into relatively acidic lysosomes as a result of iron trapping and to an energy-dependent pathway associated with the nucleoside transport system.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 240


Because of rapid distribution into tissues and high intracellular concentrations of azithromycin, tissue concentrations of the drug generally exceed plasma concentrations by 10- to 100-fold following single dose administration; with multiple dosing, the tissue-to-plasma ratio increases.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241


For more Absorption, Distribution and Excretion (Complete) data for AZITHROMYCIN (10 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed, however, this drug is eliminated by the liver,.


The principal route of biotransformation involves N-demethylation of the desosamine sugar or at the 9a position on the macrolide ring. Other metabolic pathways include O-demethylation and hydrolysis and/or hydroxylation of the cladinose and desosamine sugar moieties and the macrolide ring. Up to 10 metabolites of azithromycin have been identified, and all are microbiologically inactive. While short-term administration of azithromycin produces hepatic accumulation of the drug and increases azithromycin demethylase activity, current evidence indicates that hepatic cytochrome p450 induction of inactivation via cytochrome-metabolite complex formation does not occur. In contrast to erythromycin, azithromycin does not inhibit its own metabolism via this pathway.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241


5.7 Biological Half-Life

Terminal elimination half-life: 68 hours


An elimination half-life of 54.5 hours has been reported in children 4 months to 15 years of age receiving single or multiple oral doses of azithromycin.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241


Plasma azithromycin concentrations following a single 500-mg oral or IV dose decline in a polyphasic manner with a terminal elimination half-life averaging 68 hours. The high values for apparent steady-state volume of distribution (31.3-33.3 L/kg) and plasma clearance (630 mL/minute, 10.18 mL/minute per kg) of azithromycin suggest that the prolonged half-life is related to extensive uptake and subsequent release of the drug from tissues. The average tissue half-life of azithromycin is estimated to be 1-4 days. The half-life of the drug in peripheral leukocytes ranges from 34-57 hours.

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241


5.8 Mechanism of Action

In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins. Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit,. This results in the control of various bacterial infections,. The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broadspectrum antibacterial activities. Azithromycin is highly stable at a low pH, giving it a longer serum half-life and increasing its concentrations in tissues compared to erythromycin.


Azithromycin usually is bacteriostatic, although the drug may be bactericidal in high concentrations against selected organisms. Bactericidal activity has been observed in vitro against Streptococcus pyogenes, S. pneumoniae, and Haemophilus influenzae. Azithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of azithromycin appears to be the same as that of the macrolides (i.e., erythromycin, clarithromycin), clindamycin, lincomycin, and chloramphenicol. The antimicrobial activity of azithromycin is reduced at low pH. Azithromycin concentrates in phagocytes, including polymorphonuclear leukocytes, monocytes, macrophages, and fibroblasts. Penetration of the drug into phagocytic cells is necessary for activity against intracellular pathogens (e.g., Staphylococcus aureus, Legionella pneumophila, Chlamydia trachomatis, Salmonella typhi).

American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 238


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AZITHROMYCIN, UNSPECIFIED FORM

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Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with cGMP, 21 CFR, and ICH guidelines, and it also produces intermediates and develops new APIs as per client requirements. The company conducts biotechnological research on human therapeutic proteins, including treatments for asthma, mastocytosis, and basophilic leukemia, and supplies research-grade biotech and animal health products. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established itself as a leading generic medicine manufacturing company from India, with clients in over 51 countries. It has a facility dedicated to custom research and synthesis. Akums’ manufacturing facilities are spread across three locations in two Indian states. Its stringent policies and procedures ensure that that all regulatory requirements, environmental standards, and technological trends are met. Akums is EU-GMP, KFDA, WHO-GMP and PMDA certified.
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Azithromycin

About the Company : Anhui Sinotech Industrial Co.,Ltd is specially engaged in international marketing of food/feed additive,pesticides and chemicals. We are devoted ourselves to make the life better,a...

Anhui Sinotech Industrial Co.,Ltd is specially engaged in international marketing of food/feed additive,pesticides and chemicals. We are devoted ourselves to make the life better,always ready to provide top quality products combined with competitive price and comprehensive commercial service. By continuously efforts,the company has already established stable long-term business relationships with hundreds of oversea customers and domestic suppliers.Our products has exported to many countries and regions, including Southeast Asia,South America, Europe,etc.
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Azithromycin

About the Company : Globofarm International Pvt Ltd is a well-informed, highly efficient, Swiftly functioning competitive sourcing entity. We serve private, institutional, and corporate clients worldw...

Globofarm International Pvt Ltd is a well-informed, highly efficient, Swiftly functioning competitive sourcing entity. We serve private, institutional, and corporate clients worldwide in the field of Pharmaceuticals & Nutraceuticals. We combine our contacts, expertise, and core competency with our operations to deliver superior pharmaceutical sourcing solutions to our customers. Having our base in India, Globofarm International Pvt Ltd has been serving clients globally.
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Azithromycin

About the Company : Neha Chemicals specializes in the production and supply of high-quality Active Pharmaceutical Ingredients (APIs) for various therapeutic applications. Committed to excellence and p...

Neha Chemicals specializes in the production and supply of high-quality Active Pharmaceutical Ingredients (APIs) for various therapeutic applications. Committed to excellence and precision, Neha Chemicals ensures that each API meets stringent industry standards for purity, safety, and efficacy. With a strong focus on innovation and compliance, the company provides reliable solutions to pharmaceutical manufacturers worldwide. Neha Chemicals is dedicated to supporting global healthcare needs by delivering APIs that empower the creation of effective and affordable medicines, fostering better health outcomes across communities.
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Drugs in Development

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Details:

Belumosudil is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Graft Rejection.


Lead Product(s): Belumosudil,Azithromycin

Therapeutic Area: Immunology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 13, 2023

Sanofi Company Banner

01

Sanofi

France
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Lead Product(s) : Belumosudil,Azithromycin

Therapeutic Area : Immunology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Belumosudil is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Graft Rejection.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 13, 2023

Sanofi Company Banner

Details:

Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.


Lead Product(s): Zoliflodacin,Azithromycin,Ceftriaxone

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: The Global Antibiotic Research and Development Partnership

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 17, 2020

Dr Reddy Company Banner

02

Lead Product(s) : Zoliflodacin,Azithromycin,Ceftriaxone

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership

Deal Size : Undisclosed

Deal Type : Agreement

Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Undisclosed

December 17, 2020

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03

University of Queensland

Country
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University of Queensland

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Details : Sulbactam is a antibiotic drug, which is currently being evaluated in Phase II clinical studies for the treatment of mycobacterium abscessus pulmonary disease.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

March 20, 2026

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Details:

Contezolid is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.


Lead Product(s): Contezolid,Azithromycin,Ethambutol,Rifampicin

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Bin Cao | Shanghai Pulmonary Hospital | Beijing Chest Hospital | Anhui Chest Hospital | Jiangxi Chest Hospital | Guangzhou Chest Hospital.

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 09, 2025

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Lead Product(s) : Contezolid,Azithromycin,Ethambutol,Rifampicin

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Bin Cao | Shanghai Pulmonary Hospital | Beijing Chest Hospital | Anhui Chest Hospital | Jiangxi Chest Hospital | Guangzhou Chest Hospital.

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Contezolid is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 09, 2025

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Details:

Doxycycline is a Antibiotic drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Community-Acquired Pneumonia.


Lead Product(s): Doxycycline,Azithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 09, 2025

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Mayo Clinic

U.S.A
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Mayo Clinic

U.S.A
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Details : Doxycycline is a Antibiotic drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Community-Acquired Pneumonia.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

September 09, 2025

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Details:

Contezolid is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.


Lead Product(s): Contezolid,Azithromycin,Rifampicin,Ethambutol

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Beijing Chest Hospital, Capital Medical University | Jiangxi Provincial Chest Hospital | Bin Cao

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 24, 2025

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PEGS Boston Summit
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Lead Product(s) : Contezolid,Azithromycin,Rifampicin,Ethambutol

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Beijing Chest Hospital, Capital Medical University | Jiangxi Provincial Chest Hospital | Bin Cao

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Contezolid is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 24, 2025

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Details:

Budesonide is a Steroid drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Asthma.


Lead Product(s): Budesonide,Formoterol Fumarate,Beclomethasone Dipropionate,Fluticasone Propionate,Mometasone Furoate,Ciclesodine,Azithromycin

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Steroid

Sponsor: Penn State University | Icahn School of Medicine at Mount Sinai | University of Colorado, Denver | RAND Corporation | University of Washington | University of North Carolina | Reliant Medical Group | Kelsey Research Foundation | University of Kansas | Uni

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 08, 2025

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DARTNet Institute

Country
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DARTNet Institute

Country
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Lead Product(s) : Budesonide, Formoterol Fumarate, Beclomethasone Dipropionate, Fluticasone Propionate, Mometasone Furoate

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Penn State University | Icahn School of Medicine at Mount Sinai | University of Colorado, Denver | RAND Corporation | University of Washington | University of North Carolina | Reliant Medical Group | Kelsey Research Foundation | University of Kansas | Uni

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Asthma.

Product Name : Undisclosed

Product Type : Steroid

Upfront Cash : Inapplicable

July 08, 2025

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  • Development Update

Details:

Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gonorrhea.


Lead Product(s): Cefixime,Azithromycin,Doxycycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Aurum Institute | Nyanza Reproductive Health Society | Partners for Health and Development in Africa | National Institute of Allergy and Infectious Diseases

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 21, 2024

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University of Washington

Country
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University of Washington

Country
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Lead Product(s) : Cefixime,Azithromycin,Doxycycline

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Aurum Institute | Nyanza Reproductive Health Society | Partners for Health and Development in Africa | National Institute of Allergy and Infectious Diseases

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gonorrhea.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 21, 2024

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Details:

Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.


Lead Product(s): Zoliflodacin,Azithromycin,Ceftriaxone

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 24, 2024

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Innoviva

U.S.A
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Innoviva

U.S.A
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Details : Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

April 24, 2024

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Details:

Erythromycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Fetal Membranes, Premature Rupture.


Lead Product(s): Erythromycin,Azithromycin

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Eastern Virginia Medical School

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 23, 2024

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Inova Health Care Services

Country
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Inova Health Care Services

Country
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Details : Erythromycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Fetal Membranes, Premature Rupture.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

February 23, 2024

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INTERMEDIATE SUPPLIERS

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CAS Number : 13127-18-9

End Use API : Azithromycin

About The Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and ...

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CAS Number :

End Use API : Azithromycin

About The Company : Mehta Pharmaceutical Industries engaged in Manufacturing and marketing of APls & Advance Drug Intermediates... Locally since 1970 and Globally since 1982. Prima...

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CAS Number : 7704-67082

End Use API : Azithromycin

About The Company : Dorrapharma is engaged in R&D, manufacture and market of intermediate, API (Active Pharmaceutical Ingredients) and formulation. We stick to raise the value both...

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Pluviaendo

Turkey
PEGS Boston Summit
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Pluviaendo

Turkey
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CAS Number : 76801-85-9

End Use API : Azithromycin

About The Company : Pluvia Consumer Health is a multinational pharmaceutical company with its head office in Turkey/Istanbul & with unique molecules & know-how. Our portfolio conta...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FOR SUSPENSION;ORAL - EQ 1GM BASE/PA...DOSAGE - FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET

USFDA APPLICATION NUMBER - 50693

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DOSAGE - FOR SUSPENSION;ORAL - EQ 100MG BASE/...DOSAGE - FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML

USFDA APPLICATION NUMBER - 50710

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DOSAGE - FOR SUSPENSION;ORAL - EQ 200MG BASE/...DOSAGE - FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML

USFDA APPLICATION NUMBER - 50710

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DOSAGE - TABLET;ORAL - EQ 250MG BASE

USFDA APPLICATION NUMBER - 50711

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DOSAGE - TABLET;ORAL - EQ 600MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50730

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DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL

USFDA APPLICATION NUMBER - 50733

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DOSAGE - TABLET;ORAL - EQ 500MG BASE

USFDA APPLICATION NUMBER - 50784

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DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORA...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

USFDA APPLICATION NUMBER - 50797

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REF. STANDARDS & IMPURITIES

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EDQM

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EDQM, Council of Europe

Azithromycin for system suitability

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Azithromycin for system suitability

CAS Number : N/A

Quantity Per Vial : 0.05 mg

Sale Unit : 1

Order Code : Y0000641

Batch No : 9

Price (€) : 79

Storage : +5°C ± 3°C

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02

EDQM, Council of Europe

Azithromycin for peak identification

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Azithromycin for peak identification

CAS Number : 117772-70-0

Quantity Per Vial : 15 mg

Sale Unit : 1

Order Code : Y0000637

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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EDQM, Council of Europe

Azithromycin impurity A

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PEGS Boston Summit
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Azithromycin impurity A

CAS Number : n/a

Quantity Per Vial : 10 mg

Sale Unit : 1

Order Code : Y0000307

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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04

PEGS Boston Summit
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Azithromycin

CAS Number : 117772-70-0

Quantity Per Vial : 200 mg

Sale Unit : 1

Order Code : Y0000306

Batch No : 4

Price (€) : 79

Storage : +5°C ± 3°C

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USP

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Azithromycin C (3''-O-demethylazithromycin)

CAS Number : 620169-47-3

Quantity Per Vial :

Price ($) : 3000

Catalog Number : 1A00860

Current Lot : 25 mg

Previous Lot :

NDC Code :

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  • EDQM
  • WHO-GMP

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Azithromycin B (3-deoxyazithromycin)

CAS Number : 307974-61-4

Quantity Per Vial :

Price ($) : 3000

Catalog Number : 1A00850

Current Lot : 25 mg

Previous Lot :

NDC Code :

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3?-Demethyl-3?-N-[(4-methylphenyl) sulfonyl]a...

CAS Number : 612069-31-5

Quantity Per Vial :

Price ($) : 800

Catalog Number : 1A00840

Current Lot : 25 mg

Previous Lot :

NDC Code :

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  • EDQM
  • WHO-GMP

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3-(N,N-Didemethyl)-3-N- formylazithromycin

CAS Number : 765927-71-7

Quantity Per Vial :

Price ($) : 2364

Catalog Number : 1A00210

Current Lot : 25 mg

Previous Lot :

NDC Code :

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3-De(dimethylamino)-3- oxoazithromycin

CAS Number : 612069-25-7

Quantity Per Vial :

Price ($) : 3100

Catalog Number : 1A00080

Current Lot : 25 mg

Previous Lot :

NDC Code :

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3?-(N,N-Didemethyl) azithromycin (Aminoazithr...

CAS Number : 612069-27-9

Quantity Per Vial :

Price ($) : 882

Catalog Number : 1A00070

Current Lot : 25 mg

Previous Lot :

NDC Code :

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ANALYTICAL

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ABOUT THIS PAGE

Looking for 83905-01-5 / Azithromycin API manufacturers, exporters & distributors?

Azithromycin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Azithromycin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Azithromycin manufacturer or Azithromycin supplier for your needs.

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

API | Excipient name

Azithromycin

Synonyms

Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax

Cas Number

83905-01-5

Unique Ingredient Identifier (UNII)

J2KLZ20U1M

About Azithromycin

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Azithromycin Manufacturers

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

Azithromycin Suppliers

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

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

Azithromycin USDMF

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

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

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

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

Azithromycin KDMF

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

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

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

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

Azithromycin CEP

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

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

Azithromycin WC

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

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

Azithromycin 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 Azithromycin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Azithromycin GMP

Azithromycin 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 Azithromycin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Azithromycin GMP manufacturer or Azithromycin GMP API supplier for your needs.

Azithromycin CoA

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

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

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