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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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Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
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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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
Certificate Number : CEP 2007-072 - Rev 03
Issue Date : 2025-01-03
Type : Chemical
Substance Number : 1649
Status : Valid
| Available Reg Filing : ASMF |
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : HiCel SMCC has unique combination which result in optimum compaction & superior flow properties.
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Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Dosage Form : Tablet
Grade : Oral
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Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
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Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral
Application : Granulation
Excipient Details : Hilose is used in oral pharmaceutical formulations as a super disintegrant for capsules and tablets formulations.
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Ingredient(s) : Croscarmellose Sodium
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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 Azitrom manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azitrom, including repackagers and relabelers. The FDA regulates Azitrom manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azitrom 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 Azitrom manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azitrom supplier is an individual or a company that provides Azitrom active pharmaceutical ingredient (API) or Azitrom finished formulations upon request. The Azitrom suppliers may include Azitrom API manufacturers, exporters, distributors and traders.
click here to find a list of Azitrom suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azitrom DMF (Drug Master File) is a document detailing the whole manufacturing process of Azitrom active pharmaceutical ingredient (API) in detail. Different forms of Azitrom DMFs exist exist since differing nations have different regulations, such as Azitrom USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azitrom DMF submitted to regulatory agencies in the US is known as a USDMF. Azitrom USDMF includes data on Azitrom's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azitrom USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azitrom 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 Azitrom Drug Master File in Japan (Azitrom JDMF) empowers Azitrom 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 Azitrom JDMF during the approval evaluation for pharmaceutical products. At the time of Azitrom 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 Azitrom suppliers with JDMF on PharmaCompass.
A Azitrom CEP of the European Pharmacopoeia monograph is often referred to as a Azitrom Certificate of Suitability (COS). The purpose of a Azitrom CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azitrom EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azitrom to their clients by showing that a Azitrom CEP has been issued for it. The manufacturer submits a Azitrom CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azitrom CEP holder for the record. Additionally, the data presented in the Azitrom CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azitrom DMF.
A Azitrom CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azitrom 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 Azitrom suppliers with CEP (COS) on PharmaCompass.
A Azitrom written confirmation (Azitrom WC) is an official document issued by a regulatory agency to a Azitrom manufacturer, verifying that the manufacturing facility of a Azitrom active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azitrom APIs or Azitrom finished pharmaceutical products to another nation, regulatory agencies frequently require a Azitrom WC (written confirmation) as part of the regulatory process.
click here to find a list of Azitrom 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 Azitrom as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azitrom 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 Azitrom 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 Azitrom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azitrom NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azitrom suppliers with NDC on PharmaCompass.
Azitrom 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 Azitrom 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 Azitrom GMP manufacturer or Azitrom GMP API supplier for your needs.
A Azitrom CoA (Certificate of Analysis) is a formal document that attests to Azitrom's compliance with Azitrom specifications and serves as a tool for batch-level quality control.
Azitrom CoA mostly includes findings from lab analyses of a specific batch. For each Azitrom 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.
Azitrom may be tested according to a variety of international standards, such as European Pharmacopoeia (Azitrom EP), Azitrom JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azitrom USP).
