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    Also known as: 635728-49-3, Darunavir (ethanolate), Prezista, Rezolsta, Unii-33o78xf0bw, Tmc114 ethanolate
    Molecular Formula
    C29H43N3O8S
    Molecular Weight
    593.7  g/mol
    InChI Key
    QWSHKNICRJHQCY-VBTXLZOXSA-N
    FDA UNII
    33O78XF0BW
    Darunavir Ethanolate
    An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.
    1 2D Structure

    Darunavir Ethanolate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(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
    2.1.2 InChI
    InChI=1S/C27H37N3O7S.C2H6O/c1-18(2)15-30(38(33,34)21-10-8-20(28)9-11-21)16-24(31)23(14-19-6-4-3-5-7-19)29-27(32)37-25-17-36-26-22(25)12-13-35-26;1-2-3/h3-11,18,22-26,31H,12-17,28H2,1-2H3,(H,29,32);3H,2H2,1H3/t22-,23-,24+,25-,26+;/m0./s1
    2.1.3 InChI Key
    QWSHKNICRJHQCY-VBTXLZOXSA-N
    2.1.4 Canonical SMILES
    CCO.CC(C)CN(CC(C(CC1=CC=CC=C1)NC(=O)OC2COC3C2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N
    2.1.5 Isomeric SMILES
    CCO.CC(C)CN(C[C@H]([C@H](CC1=CC=CC=C1)NC(=O)O[C@H]2CO[C@@H]3[C@H]2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N
    2.2 Other Identifiers
    2.2.1 UNII
    33O78XF0BW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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

    2.4 Create Date
    2008-02-08
    3 Chemical and Physical Properties
    Molecular Weight 593.7 g/mol
    Molecular Formula C29H43N3O8S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count12
    Exact Mass593.27708651 g/mol
    Monoisotopic Mass593.27708651 g/mol
    Topological Polar Surface Area169 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity856
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameDarunavir ethanolate
    Drug LabelPREZISTA (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 IngredientDarunavir ethanolate
    Dosage FormTablet
    RouteOral
    Strength75mg; 150mg; 600mg; 400mg
    Market StatusTentative Approval
    CompanyTeva Pharms Usa; Hetero Labs Unit Iii

    2 of 2  
    Drug NameDarunavir ethanolate
    Drug LabelPREZISTA (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 IngredientDarunavir ethanolate
    Dosage FormTablet
    RouteOral
    Strength75mg; 150mg; 600mg; 400mg
    Market StatusTentative Approval
    CompanyTeva Pharms Usa; Hetero Labs Unit Iii

    4.2 Drug Indication

    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.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    5.2 ATC Code

    J05

    J05AE10

    API Reference Price

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TELANGANA,? 500096, N\/A","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DARUNAVIR ETHANOLATE","year":"2021","qtr":"Q2","strtotime":1618857000,"product":"(N.C.V) DARUNAVIR ETHANOLATE (BATCH NO A21AC0205) (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREETPOST BOX NO 9301","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.71","actualQuantity":"707.59","unit":"GMS","unitRateFc":"1.2","totalValueFC":"1072.6","currency":"EUR","unitRateINR":"112.9","date":"20-Apr-2021","totalValueINR":"79853.69","totalValueInUsd":"1072.6","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3636400","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"","customerAddress":"30 FORJETT STREETPOST BOX NO 9301"},{"dataSource":"API Import","activeIngredients":"DARUNAVIR ETHANOLATE","year":"2021","qtr":"Q2","strtotime":1618857000,"product":"(N.C.V) DARUNAVIR ETHANOLATE (BATCH NUMBER A21CC0563) (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREETPOST BOX NO 9301","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.77","actualQuantity":"772.02","unit":"GMS","unitRateFc":"1.2","totalValueFC":"1170.2","currency":"EUR","unitRateINR":"112.9","date":"20-Apr-2021","totalValueINR":"87123.96","totalValueInUsd":"1170.2","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3636400","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"","customerAddress":"30 FORJETT STREETPOST BOX NO 9301"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663007400,"product":"(N.C.V) DARUNAVIR ETHANOLATE (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"IRELAND","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"1.01","actualQuantity":"1005.22","unit":"GMS","unitRateFc":"1.2","totalValueFC":"1253.5","currency":"EUR","unitRateINR":"99.9","date":"13-Sep-2022","totalValueINR":"100459.09","totalValueInUsd":"1253.5","indian_port":"BOMBAY AIR","hs_no":"29359090","bill_no":"2414080","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687804200,"product":"(N.C.V)DARUNAVIR ETHANOLATE (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"IRELAND","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.75","actualQuantity":"748.83","unit":"GMS","unitRateFc":"1.2","totalValueFC":"1014.1","currency":"EUR","unitRateINR":"111.6","date":"27-Jun-2023","totalValueINR":"83355.811","totalValueInUsd":"1014.1","indian_port":"BOMBAY AIR","hs_no":"29359090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"}]
    16-Feb-2021
    26-Oct-2024
    KGS
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    Average Price (USD/KGS)

    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

    Prezista Manufacturers

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

    Prezista Suppliers

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

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

    Prezista USDMF

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

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

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

    Prezista KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Prezista Drug Master File in Korea (Prezista KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prezista. The MFDS reviews the Prezista KDMF as part of the drug registration process and uses the information provided in the Prezista KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Prezista 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 Prezista API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Prezista suppliers with KDMF on PharmaCompass.

    Prezista WC

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

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

    Prezista 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 Prezista as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Prezista GMP

    Prezista 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 Prezista 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 Prezista GMP manufacturer or Prezista GMP API supplier for your needs.

    Prezista CoA

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

    Prezista CoA mostly includes findings from lab analyses of a specific batch. For each Prezista 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.

    Prezista may be tested according to a variety of international standards, such as European Pharmacopoeia (Prezista EP), Prezista JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prezista 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.
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