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36 API Suppliers, 11 USDMF, 12 CEP/COS, 1 JDMF, 2 EU WC, 20 NDC API, 22 Listed Suppliers, $ API Reference Price

36 API Suppliers
11 USDMF
12 CEP/COS
1 JDMF
2 EU WC
20 NDC API
22 Listed Suppliers
$ API Reference Price

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72 FDF Dossiers, 1 FDA Orange Book, 15 Europe, 17 Canada, 14 South Africa, 25 Listed Dossiers

72 FDF Dossiers
1 FDA Orange Book
15 Europe
17 Canada
14 South Africa
25 Listed Dossiers

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1 Rochem International Inc, 4 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 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

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Synopsis

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API REF. PRICE (USD/KG)

$ 188

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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

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USDMF

01

Century Pharmaceuticals Ltd

India

iPHEX India

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

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India

Virtual Booth

Digital Content

AZITHROMYCIN DIHYDRATE USP

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34583

Submission : 2020-03-09

Status : Active

Type : II

02

Teva Pharmaceutical Industries Ltd

Israel

Isranalytica

Attending

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

Virtual Booth

Digital Content

AZITHROMYCIN DIHYDRATE

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-13

Pay. Date : 2014-04-25

DMF Number : 15972

Submission : 2002-05-02

Status : Active

Type : II

03

Alembic Pharmaceuticals Ltd

India

BIO Partnering at JPM

Not Confirmed

04

Alembic Pharmaceuticals Ltd

BIO Partnering at JPM

Not Confirmed

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API Reference Price

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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"157","totalValueFC":"7096.7","currency":"USD","unitRateINR":"13400","date":"03-Dec-2024","totalValueINR":"602997.75","totalValueInUsd":"7096.7","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7019359","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEU NG UK ROAD, TSUEN WAN, NT, HONG KON G CHINA China","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733164200,"product":"AZITHROMYCIN DIHYDRATE USP","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"67.00","actualQuantity":"67","unit":"KGS","unitRateFc":"157","totalValueFC":"10566.2","currency":"USD","unitRateINR":"13400","date":"03-Dec-2024","totalValueINR":"897796.65","totalValueInUsd":"10566.2","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7019359","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEU NG UK ROAD, TSUEN WAN, NT, HONG KON G CHINA China","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733164200,"product":"AZITHROMYCIN DIHYDRATE USP","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"388.00","actualQuantity":"388","unit":"KGS","unitRateFc":"157","totalValueFC":"61189.2","currency":"USD","unitRateINR":"13400","date":"03-Dec-2024","totalValueINR":"5199180.6","totalValueInUsd":"61189.2","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7019359","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEU NG UK ROAD, TSUEN WAN, NT, HONG KON G CHINA China","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734287400,"product":"AZITHROMYCIN DIHYDRATE USP(BATCH NO.A20240908)AZITHROMYCIN","address":"5TH FLOOR,LAXMI NARAYAN COMPLEX,","city":"BANGALORE","supplier":"HANGZHOU DAWN RAY ","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"BAL PHARMA","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"142","totalValueFC":"42941.4","currency":"USD","unitRateINR":"12162.3","date":"16-Dec-2024","totalValueINR":"3648690","totalValueInUsd":"42941.4","indian_port":"Bangalore Air","hs_no":"29419090","bill_no":"7259235","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"CO., LTD 1613, GUANGYIN BUILDING, NO.42 E.FENGQI ROAD, HANGZHOU 31001 2 CHINA CHINA","customerAddress":"5TH FLOOR,LAXMI NARAYAN COMPLEX,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Azithromycin Monohydrate Manufacturers

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

Azithromycin Monohydrate Suppliers

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

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

Azithromycin Monohydrate USDMF

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

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

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

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

Azithromycin Monohydrate CEP

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

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

Azithromycin Monohydrate WC

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

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

Azithromycin Monohydrate 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 Monohydrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Azithromycin Monohydrate GMP

Azithromycin Monohydrate 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 Monohydrate 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 Azithromycin Monohydrate GMP manufacturer or Azithromycin Monohydrate GMP API supplier for your needs.

Azithromycin Monohydrate CoA

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

Azithromycin Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Azithromycin Monohydrate 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 Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Azithromycin Monohydrate EP), Azithromycin Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azithromycin Monohydrate 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.

Find Azithromycin Dihydrate manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers

11 USDMF

12 CEP/COS

1 JDMF

2 EU WC

20 NDC API

22 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

72 FDF Dossiers

1 FDA Orange Book

15 Europe

17 Canada

14 South Africa

25 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives

33 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 Topical

5 Empty Capsules

5 API Stability Enhancers

4 Solubilizers

4 Emulsifying Agents

4 Rheology Modifiers

4 Chewable & Orodispersible Aids

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