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1. 114, Tmc
2. Darunavir
3. Ethanolate, Darunavir
4. Prezista
5. Tmc 114
6. Tmc-114
7. Tmc114
8. Uic 94017
9. Uic-94017
10. Uic94017
1. 635728-49-3
2. Darunavir (ethanolate)
3. Prezista
4. Rezolsta
5. Unii-33o78xf0bw
6. Tmc114 Ethanolate
7. Darunavir Monoethanolate
8. Darunavir (as Ethanolate)
9. 33o78xf0bw
10. Darunavir Ethanolate (prezista)
11. [(3as,4r,6ar)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2s,3r)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate;ethanol
12. Darunavir Ethanolate (jan)
13. Darunavir Ethanolate [jan]
14. Carbamic Acid, ((1s,2r)-3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-(phenylmethyl)propyl)-, (3r,3as,6ar)-hexahydrofuro(2,3-b)furan-3-yl Ester, Compd. With Ethanol (1:1)
15. Uic 94017
16. [14c]-darunavir Ethanolate
17. Prezista (tn)
18. Darunavir?ethanolate
19. Darunavir Ethanolate- Bio-x
20. Schembl562454
21. Chembl1201127
22. Dtxsid70979794
23. Symtuza Component Darunavir
24. Amy39006
25. Darunavir Ethanolate [vandf]
26. Darunavir Ethanolate [mart.]
27. Darunavir Monoethanolate [mi]
28. Mfcd18251642
29. Darunavir Component Of Symtuza
30. Darunavir Ethanolate [who-dd]
31. Akos025149225
32. Bcp9000588
33. Ccg-270170
34. Cs-0750
35. Ac-26777
36. As-35215
37. Bd164352
38. Darunavir Ethanolate [orange Book]
39. Hy-17041
40. S1620
41. Sw219052-1
42. D06478
43. Prezcobix Component Darunavir Ethanolate
44. A847955
45. Darunavir Ethanolate Component Of Prezcobix
46. Q27256287
47. ((1s,2r)-3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-(phenylmethyl)propyl)- Carbamic Acid (3r,3as,6ar)-hexahydrofuro(2,3-b)furan-3-yl Ester Monoethanolate
48. (3r,3as,6ar)-hexahydrofuro(2,3-b)furan-3-yl ((1s,2r)-3-(((4-aminophenyl)sulfonyl)(isobutyl)amino)-1-benzyl-2-hydroxypropyl)carbamate - Ethanol (1:1)
49. (3r,3as,6ar)-hexahydrofuro[2,3-b]furan-3-yl ((2s,3r)-4-(4-amino-n-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamate Ethanolate
50. (3r,3as,6ar)-hexahydrofuro[2,3-b]furan-3-yl((2s,3r)-4-((4-amino-n-isobutylphenyl)sulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamatecompoundwithethanol(1:1)
51. [(3as,4r,6ar)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2s,3r)-4-[(4-aminophenyl) Sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate; Ethanol; Tmc114
52. 635728-39-1
53. Hexahydrofuro[2,3-b]furan-3-yl Hydrogen {4-[(4-aminobenzene-1-sulfonyl)(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl}carbonimidate--ethanol (1/1)
54. N-[(1s,2r)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic Acid (3r,3as,6ar)-hexahydrofuro[2,3-b]furan-3-yl Ester Compd. With Ethanol
Molecular Weight | 593.7 g/mol |
---|---|
Molecular Formula | C29H43N3O8S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 12 |
Exact Mass | 593.27708651 g/mol |
Monoisotopic Mass | 593.27708651 g/mol |
Topological Polar Surface Area | 169 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 856 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 5 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Darunavir ethanolate |
Drug Label | PREZISTA (darunavir) is an inhibitor of the human immunodeficiency virus (HIV) protease.PREZISTA (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-... |
Active Ingredient | Darunavir ethanolate |
Dosage Form | Tablet |
Route | Oral |
Strength | 75mg; 150mg; 600mg; 400mg |
Market Status | Tentative Approval |
Company | Teva Pharms Usa; Hetero Labs Unit Iii |
2 of 2 | |
---|---|
Drug Name | Darunavir ethanolate |
Drug Label | PREZISTA (darunavir) is an inhibitor of the human immunodeficiency virus (HIV) protease.PREZISTA (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-... |
Active Ingredient | Darunavir ethanolate |
Dosage Form | Tablet |
Route | Oral |
Strength | 75mg; 150mg; 600mg; 400mg |
Market Status | Tentative Approval |
Company | Teva Pharms Usa; Hetero Labs Unit Iii |
Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.
Genotypic testing should guide the use of Rezolsta.
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.
PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).
In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.
PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:
- For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated.
- For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.
In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.
PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).
PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
- antiretroviral therapy (ART) nave.
- ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.
HIV Protease Inhibitors
Inhibitors of HIV PROTEASE, an enzyme required for production of proteins needed for viral assembly. (See all compounds classified as HIV Protease Inhibitors.)
J05
J05AE10
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Average Price (USD/KGS) |
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ABOUT THIS PAGE
A Darunavir Ethanolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darunavir Ethanolate, including repackagers and relabelers. The FDA regulates Darunavir Ethanolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darunavir Ethanolate 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 Darunavir Ethanolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darunavir Ethanolate supplier is an individual or a company that provides Darunavir Ethanolate active pharmaceutical ingredient (API) or Darunavir Ethanolate finished formulations upon request. The Darunavir Ethanolate suppliers may include Darunavir Ethanolate API manufacturers, exporters, distributors and traders.
click here to find a list of Darunavir Ethanolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Darunavir Ethanolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Darunavir Ethanolate active pharmaceutical ingredient (API) in detail. Different forms of Darunavir Ethanolate DMFs exist exist since differing nations have different regulations, such as Darunavir Ethanolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darunavir Ethanolate DMF submitted to regulatory agencies in the US is known as a USDMF. Darunavir Ethanolate USDMF includes data on Darunavir Ethanolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darunavir Ethanolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darunavir Ethanolate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Darunavir Ethanolate Drug Master File in Korea (Darunavir Ethanolate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Darunavir Ethanolate. The MFDS reviews the Darunavir Ethanolate KDMF as part of the drug registration process and uses the information provided in the Darunavir Ethanolate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Darunavir Ethanolate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Darunavir Ethanolate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Darunavir Ethanolate suppliers with KDMF on PharmaCompass.
A Darunavir Ethanolate written confirmation (Darunavir Ethanolate WC) is an official document issued by a regulatory agency to a Darunavir Ethanolate manufacturer, verifying that the manufacturing facility of a Darunavir Ethanolate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Darunavir Ethanolate APIs or Darunavir Ethanolate finished pharmaceutical products to another nation, regulatory agencies frequently require a Darunavir Ethanolate WC (written confirmation) as part of the regulatory process.
click here to find a list of Darunavir Ethanolate 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 Darunavir Ethanolate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Darunavir Ethanolate 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 Darunavir Ethanolate 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 Darunavir Ethanolate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Darunavir Ethanolate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Darunavir Ethanolate suppliers with NDC on PharmaCompass.
Darunavir Ethanolate 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 Darunavir Ethanolate 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 Darunavir Ethanolate GMP manufacturer or Darunavir Ethanolate GMP API supplier for your needs.
A Darunavir Ethanolate CoA (Certificate of Analysis) is a formal document that attests to Darunavir Ethanolate's compliance with Darunavir Ethanolate specifications and serves as a tool for batch-level quality control.
Darunavir Ethanolate CoA mostly includes findings from lab analyses of a specific batch. For each Darunavir Ethanolate 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.
Darunavir Ethanolate may be tested according to a variety of international standards, such as European Pharmacopoeia (Darunavir Ethanolate EP), Darunavir Ethanolate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Darunavir Ethanolate USP).
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