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1. (3ar,4r,7s,9r,10r,11r,13r,15r,15ar)-1-(4-(4-(3-aminophenyl)-1h-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-trideoxy-(dimethylamino)-
2. Cem 101
3. Cem-101
4. Op 1068
5. Op-1068
1. Cem-101
2. Solithera
3. 760981-83-7
4. Op-1068
5. Cem 101
6. Op 1068
7. 9u1eth79ck
8. (1s,2r,5s,7r,8r,9r,11r,13r,14r)-15-[4-[4-(3-aminophenyl)triazol-1-yl]butyl]-8-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-5-fluoro-9-methoxy-1,5,7,9,11,13-hexamethyl-3,17-dioxa-15-azabicyclo[12.3.0]heptadecane-4,6,12,16-tetrone
9. (3as,4r,7s,9r,10r,11r,13r,15r,15ar)-1-{4-[4-(3-aminophenyl)-1h-1,2,3-triazol-1-yl]butyl}-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-2,6,8,14-tetraoxotetradecahydro-2h-oxacyclotetradecino[4,3-d][1,3]oxazol-10-yl 3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranoside
10. Solithromycin [usan]
11. Unii-9u1eth79ck
12. Solithromycin [usan:inn]
13. Solithromycin [inn]
14. Solithromycin [jan]
15. Solithromycin [who-dd]
16. Cem101
17. Chembl1232510
18. Schembl19114493
19. Gtpl10859
20. Dtxsid501028410
21. Ex-a2272
22. Opt-1068
23. Op1068
24. Zinc95627834
25. Akos032947334
26. Compound 3 [pmid: 30258539]
27. Cs-5053
28. Db09308
29. Solithromycin; Cem-101; Op-1068
30. Hy-17593
31. T4288
32. T-4288
33. A865552
34. Q7558263
35. (1r,2r,4r,6r,7r,8r,10s,13r,14s)-17-[4-[4-(3-aminophenyl)triazol-1-yl]butyl]-7-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-13-ethyl-10-fluoro-6-methoxy-2,4,6,8,10,14-hexamethyl-12,15-dioxa-17-azabicyclo[12.3.0]heptadecane-3,9,11,16-tetrone
36. (3ar,4r,7s,9r,10r,11r,13r,15r,15ar)-1-(4-(4-(3-aminophenyl)-1h-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-((trideoxy-(dimethylamino)-
37. (3as,4r,7s,9r,10r,11r,13r,15r,15ar)-1-{4-[4-(3-aminophenyl)-1h-1,2,3-triazol-1-yl]butyl}-4-ethyl-7-fluoro-11-methoxy-3a
38. 2h-oxacyclotetradecino(4,3-d)oxazole-2,6,8,14(1h,7h,9h)-tetrone, 1-(4-(4-(3-aminophenyl)-1h-1,2,3-triazol-1-yl)butyl)-4-ethyl-7- Fluorooctahydro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-, (3as,4r,7s,9r,10r,11r,13r,15r,15ar)-
39. Em1
| Molecular Weight | 845.0 g/mol |
|---|---|
| Molecular Formula | C43H65FN6O10 |
| XLogP3 | 4.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 15 |
| Rotatable Bond Count | 11 |
| Exact Mass | 844.47462045 g/mol |
| Monoisotopic Mass | 844.47462045 g/mol |
| Topological Polar Surface Area | 198 Ų |
| Heavy Atom Count | 60 |
| Formal Charge | 0 |
| Complexity | 1530 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 13 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Investigated for the treatment of community-acquired pneumonia (CAP).
Treatment of gonococcal infection
Treatment of anthrax, Treatment of tularaemia, Treatment of bacterial pneumonia
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01F - Macrolides, lincosamides and streptogramins
J01FA - Macrolides
J01FA16 - Solithromycin
API SUPPLIERS
Registration Number : 231MF10087
Registrant's Address : 3558 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Initial Date of Registration : 2019-04-11
Latest Date of Registration : --
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ABOUT THIS PAGE
A Solithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solithromycin, including repackagers and relabelers. The FDA regulates Solithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solithromycin 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 Solithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solithromycin supplier is an individual or a company that provides Solithromycin active pharmaceutical ingredient (API) or Solithromycin finished formulations upon request. The Solithromycin suppliers may include Solithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Solithromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Solithromycin Drug Master File in Japan (Solithromycin JDMF) empowers Solithromycin 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 Solithromycin JDMF during the approval evaluation for pharmaceutical products. At the time of Solithromycin 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 Solithromycin suppliers with JDMF on PharmaCompass.
Solithromycin 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 Solithromycin 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 Solithromycin GMP manufacturer or Solithromycin GMP API supplier for your needs.
A Solithromycin CoA (Certificate of Analysis) is a formal document that attests to Solithromycin's compliance with Solithromycin specifications and serves as a tool for batch-level quality control.
Solithromycin CoA mostly includes findings from lab analyses of a specific batch. For each Solithromycin 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.
Solithromycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Solithromycin EP), Solithromycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solithromycin USP).
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