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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 11 USDMF, 12 CEP/COS, 2 EU WC, 21 NDC API, 21 Listed Suppliers, $ API Reference Price

36 API Suppliers
11 USDMF
12 CEP/COS
2 EU WC
21 NDC API
21 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 1 FDA Orange Book, 15 Europe, 17 Canada, 14 South Africa, 24 Listed Dossiers

71 FDF Dossiers
1 FDA Orange Book
15 Europe
17 Canada
14 South Africa
24 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 7 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 4 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 34 Fillers, Diluents & Binders, 18 Direct Compression, 18 Controlled & Modified Release, 16 Granulation, 13 Lubricants & Glidants, 11 Disintegrants & Superdisintegrants, 10 Thickeners and Stabilizers, 8 Film Formers & Plasticizers, 8 Co-Processed Excipients, 7 Taste Masking, 5 Empty Capsules, 5 API Stability Enhancers, 5 Topical, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Solubilizers, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 3 Parenteral, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

MARKET PLACE

51 APIs, 1 FDF Dossiers

marketPlace
51 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

27 Health Canada Patents

patents
27 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 190

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

138 RELATED EXCIPIENT COMPANIES

231EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 117772-70-0, Vinzam, Toraseptol, Azithromycin (hydrate), Azitro, 5fd1131i7s

Molecular Formula

C₃₈H₇₆N₂O₁₄

Molecular Weight

785.0 g/mol

InChI Key

SRMPHJKQVUDLQE-KUJJYQHYSA-N

FDA UNII

5FD1131I7S

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

1 2D Structure

Azithromycin Dihydrate

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;dihydrate

2.1.2 InChI

InChI=1S/C38H72N2O12.2H2O/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;2*1H2/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

SRMPHJKQVUDLQE-KUJJYQHYSA-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.O.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.O.O

2.2 Other Identifiers

2.2.1 UNII

5FD1131I7S

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Azadose

2. Azithromycin

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. 117772-70-0

2. Vinzam

3. Toraseptol

4. Azithromycin (hydrate)

5. Azitro

6. 5fd1131i7s

7. 117772-70-0 (dihydrate)

8. Azithromycin Hydrate

9. Azitromax

10. Misultina

11. Tromix

12. Azadose

13. Ribotrex

14. Ultreon

15. Zenstavion

16. Azatek

17. Goxal

18. (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 Dihydrate

19. Azithromycin (as Dihydrate)

20. Odaz

21. (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 Dihydrate

22. Aciphar

23. Acitrocin

24. Azidromic

25. Azitral

26. Azitrix

27. Azitrom

28. Azitrox

29. Azitroxil

30. Azimix

31. Unii-5fd1131i7s

32. Azitrona Klonal

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

34. Azithromycin [mart.]

35. Schembl134723

36. Chebi:34546

37. Dtxsid80922539

38. Azithromycin Dihydrate 100 Microg/ml In Acetonitrile

39. Azithromycin Hydrate [jan]

40. Azithromycin Dihydrate [mi]

41. Ac-093

42. Hy-17506a

43. Azithromycin Dihydrate [vandf]

44. Akos015896370

45. Azithromycin Dihydrate [who-dd]

46. Azithromycin Dihydrate, >=98% (hplc)

47. (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 Dihydrate

48. 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)-, Dihydrate, (2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*))-

49. Azithromycin Dihydrate [orange Book]

50. Azithromycin Dihydrate [ep Monograph]

51. Azithromycin Dihydrate [usp Monograph]

52. 772a700

53. N-methyl-11-aza-10-deoxo-10-dihydro Erythromycin A

54. Q27116139

55. Azithromycin, United States Pharmacopeia (usp) Reference Standard

56. N-methyl-11-aza-10-deoxo-10-dihydroerythromycin A Dihydrate

57. Azithromycin, Pharmaceutical Secondary Standard; Certified Reference Material

58. (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-onedihydrate

59. (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-o

60. (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;dihydrate

61. 1-oxa-6-azacyclopentadecan-15-one, 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]-, Dihydrate, (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₃₈H₇₆N₂O₁₄
Molecular Weight	785.0 g/mol
Hydrogen Bond Donor Count	7
Hydrogen Bond Acceptor Count	16
Rotatable Bond Count	7
Exact Mass	784.52965510 g/mol
Monoisotopic Mass	784.52965510 g/mol
Topological Polar Surface Area	182 Å²
Heavy Atom Count	54
Formal Charge	0
Complexity	1150
Isotope Atom Count	0
Defined Atom Stereocenter Count	18
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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

4.2 FDA Pharmacological Classification

4.2.1 Pharmacological Classes

Macrolides [CS]; Macrolide Antimicrobial [EPC]

API SUPPLIERS

01

Century Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Exhibiting

Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AAPS 2024

Attending

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Attending

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

Tenatra Chemie

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Attending

Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Website

05

Zhejiang Guobang Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AAPS 2024

Not Confirmed

Not Confirmed

10

Teva API

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AAPS 2024

Not Confirmed

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API Reference Price

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