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    Chemistry

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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

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OF","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"48,49,50,209,210 211.PHASE-II, ","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716748200,"product":"DARUNAVIR ETHANOLATE","address":"N\/A","city":"","supplier":"TIANISH LABORATORIES","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"SARL LABORATOIRES BEKER","customerCountry":"ALGERIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"1000","totalValueFC":"5841.6","currency":"USD","unitRateINR":81154.166666666672,"date":"27-May-2024","totalValueINR":"486925","totalValueInUsd":"5841.6","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"1200935","productDescription":"API","marketType":"","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"N\/A, ","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721068200,"product":"DARUNAVIR ETHANOLATE","address":"48,49,50,209,210 211.PHASE-II","city":"N\/A","supplier":"ARENE LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"MATHIESEN COLOMBIA SAS","customerCountry":"COLOMBIA","quantity":"255.00","actualQuantity":"255","unit":"KGS","unitRateFc":"330","totalValueFC":"81194.7","currency":"USD","unitRateINR":26616.274392156862,"date":"16-Jul-2024","totalValueINR":"6787149.97","totalValueInUsd":"81194.7","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"2467551","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"48,49,50,209,210 211.PHASE-II, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"DARUNAVIR ETHANOLATE","address":"48,49,50,209,210 211.PHASE-II","city":"N\/A","supplier":"ARENE LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JEDDAH","customer":"SAUDI ARABIAN JAPANESE","customerCountry":"SAUDI ARABIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"437","totalValueFC":"2127.1","currency":"USD","unitRateINR":35683.919999999998,"date":"22-Aug-2024","totalValueINR":"178419.6","totalValueInUsd":"2127.1","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"3385949","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"48,49,50,209,210 211.PHASE-II, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728325800,"product":"DARUNAVIR ETHANOLATE","address":"Plot no 564-A-22, Road No 92 ,? 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TELANGANA,? 500096, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742495400,"product":"DARUNAVIR ETHANOLATE, B.NO.: BOD-7\/002\/25,MFG.DT:FEB-2025EXP.DT:JAN-2029MFG.BY:SATYADEEPTHA PHARMACEUTICALS LIMITED.INDI","address":"N\/A","city":"N\/A","supplier":"ESSON PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"LLC PHARMCONCEPT","customerCountry":"RUSSIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"51000","totalValueFC":"5564.7","currency":"INR","unitRateINR":48200,"date":"21-Mar-2025","totalValueINR":"482000","totalValueInUsd":"5564.7","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"9206718","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"DARUNAVIR ETHANOLATE(PHARMACEUTICAL RAWMATERIALS)(AS PER INV & PKG)","address":"NO 11, GEE TECH AND TRANS PRIVATE LIMITED","city":"PUDUKKOTTAI","supplier":"GEE TECH AND TRANS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"M\/S CLINICOS Y HOSPITALARIOS DE COL","customerCountry":"COLOMBIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"350","totalValueFC":"255592.7","currency":"USD","unitRateINR":29518.433333333334,"date":"27-Mar-2025","totalValueINR":"22138825","totalValueInUsd":"255592.7","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9410312","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NO 11, GEE TECH AND TRANS PRIVATE LIMITED, PUDUKKOTTAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DARUNAVIR ETHANOLATE","year":"2021","qtr":"Q2","strtotime":1618857000,"product":"(N.C.V) DARUNAVIR ETHANOLATE (BATCH NUMBER A21CC0599) (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":"0.74","actualQuantity":"737.81","unit":"GMS","unitRateFc":"1.2","totalValueFC":"1118.4","currency":"EUR","unitRateINR":"112.9","date":"20-Apr-2021","totalValueINR":"83264.04","totalValueInUsd":"1118.4","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":"Q1","strtotime":1643826600,"product":"(N.C.V) DARUNAVIR ETHANOLATE (FOR TESTING PURPOSE ONLY)","address":"L.B.S. 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    ABOUT THIS PAGE

    Looking for 635728-49-3 / Darunavir Ethanolate API manufacturers, exporters & distributors?

    Darunavir Ethanolate manufacturers, exporters & distributors 1

    61

    PharmaCompass offers a list of Darunavir Ethanolate 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 Darunavir Ethanolate manufacturer or Darunavir Ethanolate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Darunavir Ethanolate manufacturer or Darunavir Ethanolate supplier.

    PharmaCompass also assists you with knowing the Darunavir Ethanolate API Price utilized in the formulation of products. Darunavir Ethanolate API Price is not always fixed or binding as the Darunavir Ethanolate Price is obtained through a variety of data sources. The Darunavir Ethanolate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Darunavir Ethanolate

    Synonyms

    635728-49-3, Darunavir (ethanolate), Prezista, Rezolsta, Unii-33o78xf0bw, Tmc114 ethanolate

    Cas Number

    635728-49-3

    Unique Ingredient Identifier (UNII)

    33O78XF0BW

    About 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.

    Darunavir Ethanolate Manufacturers

    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.

    Darunavir Ethanolate Suppliers

    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.

    Darunavir Ethanolate USDMF

    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.

    Darunavir Ethanolate KDMF

    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.

    Darunavir Ethanolate WC

    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.

    Darunavir Ethanolate 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 Darunavir Ethanolate as an active pharmaceutical ingredient (API).

    Finished drug products

    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.

    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 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.

    Compounded drug products

    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 GMP

    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.

    Darunavir Ethanolate CoA

    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).

    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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