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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
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)-
| Molecular Weight | 785.0 g/mol |
|---|---|
| Molecular Formula | C38H76N2O14 |
| 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 Ų |
| 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 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34583
Submission : 2020-03-09
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-13
Pay. Date : 2014-04-25
DMF Number : 15972
Submission : 2002-05-02
Status : Active
Type : II
| Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-13
Pay. Date : 2021-06-24
DMF Number : 30887
Submission : 2016-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34853
Submission : 2020-05-21
Status : Active
Type : II
Certificate Number : CEP 2005-230 - Rev 03
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 1649
Status : Valid
NDC Package Code : 61294-9990
Start Marketing Date : 2020-04-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-09
Pay. Date : 2014-12-30
DMF Number : 28837
Submission : 2014-10-31
Status : Active
Type : II
Certificate Number : R1-CEP 2007-230 - Rev 04
Issue Date : 2022-01-04
Type : Chemical
Substance Number : 1649
Status : Valid
NDC Package Code : 43781-0305
Start Marketing Date : 2015-10-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-28
Pay. Date : 2017-03-01
DMF Number : 30966
Submission : 2016-12-01
Status : Active
Type : II
Certificate Number : R1-CEP 2007-119 - Rev 06
Issue Date : 2022-09-29
Type : Chemical
Substance Number : 1649
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-08
Pay. Date : 2023-09-22
DMF Number : 36895
Submission : 2022-03-08
Status : Active
Type : II
Certificate Number : R1-CEP 2013-153 - Rev 03
Issue Date : 2023-08-10
Type : Chemical
Substance Number : 1649
Status : Valid
NDC Package Code : 51943-120
Start Marketing Date : 2023-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Azithromycin Dihydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier.
PharmaCompass also assists you with knowing the Azithromycin Dihydrate API Price utilized in the formulation of products. Azithromycin Dihydrate API Price is not always fixed or binding as the Azithromycin Dihydrate Price is obtained through a variety of data sources. The Azithromycin Dihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
