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    Chemistry

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    Also known as: 229975-97-7, Reyataz, Atazanavir sulphate, Bms-232632-05, Atazanavir (sulfate), Atazanavir sulfate [usan]
    Molecular Formula
    C38H54N6O11S
    Molecular Weight
    802.9  g/mol
    InChI Key
    DQSGVVGOPRWTKI-QVFAWCHISA-N
    FDA UNII
    4MT4VIE29P
    Atazanavir Sulfate
    An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.
    1 2D Structure

    Atazanavir Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;sulfuric acid
    2.1.2 InChI
    InChI=1S/C38H52N6O7.H2O4S/c1-37(2,3)31(41-35(48)50-7)33(46)40-29(22-25-14-10-9-11-15-25)30(45)24-44(43-34(47)32(38(4,5)6)42-36(49)51-8)23-26-17-19-27(20-18-26)28-16-12-13-21-39-28;1-5(2,3)4/h9-21,29-32,45H,22-24H2,1-8H3,(H,40,46)(H,41,48)(H,42,49)(H,43,47);(H2,1,2,3,4)/t29-,30-,31+,32+;/m0./s1
    2.1.3 InChI Key
    DQSGVVGOPRWTKI-QVFAWCHISA-N
    2.1.4 Canonical SMILES
    CC(C)(C)C(C(=O)NC(CC1=CC=CC=C1)C(CN(CC2=CC=C(C=C2)C3=CC=CC=N3)NC(=O)C(C(C)(C)C)NC(=O)OC)O)NC(=O)OC.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    CC(C)(C)[C@@H](C(=O)N[C@@H](CC1=CC=CC=C1)[C@H](CN(CC2=CC=C(C=C2)C3=CC=CC=N3)NC(=O)[C@H](C(C)(C)C)NC(=O)OC)O)NC(=O)OC.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    4MT4VIE29P
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 232632, Bms

    2. 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioic Acid Dimethyl Ester

    3. Atazanavir

    4. Bms 232632

    5. Bms 232632 05

    6. Bms-232632

    7. Bms-232632-05

    8. Bms232632

    9. Bms23263205

    10. Cgp 73547

    11. Cgp 75136

    12. Cgp 75176

    13. Cgp 75355

    14. Cgp-73547

    15. Cgp-75136

    16. Cgp-75176

    17. Cgp-75355

    18. Cgp73547

    19. Cgp75136

    20. Cgp75176

    21. Cgp75355

    22. Reyataz

    2.3.2 Depositor-Supplied Synonyms

    1. 229975-97-7

    2. Reyataz

    3. Atazanavir Sulphate

    4. Bms-232632-05

    5. Atazanavir (sulfate)

    6. Atazanavir Sulfate [usan]

    7. Atazor

    8. Atazanavir So4

    9. 4mt4vie29p

    10. Atazanavir Sulfate (bms-232632-05)

    11. 229975-97-7 (sulfate)

    12. Nsc-742546

    13. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulfate (1:1) (salt)

    14. Reyataz (tn)

    15. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulfate (1:1) (salt)

    16. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, Sulfate (1:1) (salt)

    17. Chebi:31243

    18. Smr002544693

    19. Atazanavir Bisulfate Salt

    20. Unii-4mt4vie29p

    21. Ulfuric Acid

    22. Atazanaviri Sulfas

    23. Mls003915641

    24. Mls006010199

    25. Schembl341700

    26. Atazanavir So4 [vandf]

    27. Atazanavir Sulfate [mi]

    28. Atazanavir Sulfate (jan/usan)

    29. Atazanavir Sulfate [jan]

    30. Chembl1200678

    31. Bms-232632-05, Reyataz

    32. Dtxsid401017206

    33. Atazanavir Sulfate [mart.]

    34. Amy36999

    35. Atazanavir Sulfate [usp-rs]

    36. Atazanavir Sulfate [who-dd]

    37. Atazanavir Sulfate [who-ip]

    38. Ex-a4010

    39. Methyl N-[(2s)-1-[2-[(2s,3s)-2-hydroxy-3-[[(2s)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;sulfuric Acid

    40. Hy-17367a

    41. Mfcd08067748

    42. S1457

    43. Akos016000176

    44. Atazanavir Sulphate [ema Epar]

    45. Ccg-270493

    46. Cs-1890

    47. Nsc 742546

    48. Atazanavir Sulfate [orange Book]

    49. Atazanavir Sulfate [ep Monograph]

    50. As-14954

    51. Atazanaviri Sulfas [who-ip Latin]

    52. Evotaz Component Atazanavir Sulfate

    53. Methyl ((5s,10s,11s,14s)-11-benzyl-5-(tert-butyl)-10-hydroxy-15,15-dimethyl-3,6,13-trioxo-8-(4-(pyridin-2-yl)benzyl)-2-oxa-4,7,8,12-tetraazahexadecan-14-yl)carbamate Sulfate

    54. Atazanavir Sulfate Component Of Evotaz

    55. Sw220258-1

    56. D01276

    57. 975a977

    58. A816475

    59. J-014934

    60. 3-amino-3-(3-benzyloxy-phenyl)-propionicacid

    61. Q27114238

    62. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulphate (1:1) (salt)

    63. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, Sulphate (1:1) (salt)

    64. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12-di-tert-butyl-8-hydroxy-4,11-dioxo-6-((4-(pyridin-2-yl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioate Monosulfate

    65. Methyl N-[(1s)-1-[[(1s,2s)-1-benzyl-2-hydroxy-3-[[[(2s)-2-(methoxycarbonylamino)-3,3-dimethyl-butanoyl]amino]-[(4-phenylphenyl)methyl]amino]propyl]carbamoyl]-2,2-dimethyl-propyl]carbamate; Sulfuric Acid;atazanavir Sulfate

    66. Methyl N-[(2s)-1-[2-[(2s,3s)-2-hydroxy-3-[[(2s)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;s

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 802.9 g/mol
    Molecular Formula C38H54N6O11S
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count13
    Rotatable Bond Count18
    Exact Mass802.35712773 g/mol
    Monoisotopic Mass802.35712773 g/mol
    Topological Polar Surface Area254 Ų
    Heavy Atom Count56
    Formal Charge0
    Complexity1190
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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 4  
    Drug NameAtazanavir sulfate
    Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
    Active IngredientAtazanavir sulfate
    Dosage FormCapsule
    Routeoral; Oral
    Strength300mg; eq 100mg base; 200mg; eq 200mg base; 100mg; eq 300mg base; 150mg; eq 150mg base
    Market StatusTentative Approval; Prescription
    CompanyMatrix Labs; Emcure Pharms; Aurobindo Pharma; Teva Pharms Usa; Emcure Pharma

    2 of 4  
    Drug NameReyataz
    PubMed HealthAtazanavir (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
    Active IngredientAtazanavir sulfate
    Dosage FormCapsule; Powder
    RouteOral
    Strengtheq 50mg base/packet; eq 150mg base; eq 200mg base; eq 300mg base
    Market StatusPrescription
    CompanyBristol Myers Squibb

    3 of 4  
    Drug NameAtazanavir sulfate
    Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
    Active IngredientAtazanavir sulfate
    Dosage FormCapsule
    Routeoral; Oral
    Strength300mg; eq 100mg base; 200mg; eq 200mg base; 100mg; eq 300mg base; 150mg; eq 150mg base
    Market StatusTentative Approval; Prescription
    CompanyMatrix Labs; Emcure Pharms; Aurobindo Pharma; Teva Pharms Usa; Emcure Pharma

    4 of 4  
    Drug NameReyataz
    PubMed HealthAtazanavir (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
    Active IngredientAtazanavir sulfate
    Dosage FormCapsule; Powder
    RouteOral
    Strengtheq 50mg base/packet; eq 150mg base; eq 200mg base; eq 300mg base
    Market StatusPrescription
    CompanyBristol Myers Squibb

    4.2 Drug Indication

    Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4. 2).

    Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations).

    The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patients treatment history (see sections 4. 4 and 5. 1).

    Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4. 2).

    Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patients treatment history (see sections 4. 4 and 5. 1).

    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 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cytochrome P450 3A Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; HIV Protease Inhibitors [MoA]; Protease Inhibitor [EPC]; UDP Glucuronosyltransferases Inhibitors [MoA]; UGT1A1 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]
    5.3 ATC Code

    J05AE08

    API Reference Price

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O","customerCountry":"COLOMBIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"360","totalValueFC":"86417.6","currency":"USD","unitRateINR":28703.011999999999,"date":"31-Mar-2024","totalValueINR":"7175753","totalValueInUsd":"86417.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"8792951","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Villa NO 29, Aparna Elixir,Near ORR, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"ATAZANAVIR SULFATE","address":"SECOND FLOOR, BLOCK-III,MY HOME HUB","city":"HYDERABAD, AP","supplier":"GRANULES INDIA LIMITED","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"REMEDICA LTD","customerCountry":"CYPRUS","quantity":"251.21","actualQuantity":"251.21","unit":"KGS","unitRateFc":"900","totalValueFC":"220962","currency":"USD","unitRateINR":73710.788623064363,"date":"30-Sep-2024","totalValueINR":"18516887.21","totalValueInUsd":"220962","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"4486440","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"ATAZANAVIR SULFATE","address":"2ND FLOOR, SERENE CHAMBERS,","city":"N\/A","supplier":"LAURUS LABS","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"GLOBAL PHARMA & ","customerCountry":"COLOMBIA","quantity":"160.00","actualQuantity":"160","unit":"KGS","unitRateFc":"475","totalValueFC":"73873.6","currency":"USD","unitRateINR":38691.849625000003,"date":"30-Sep-2024","totalValueINR":"6190695.94","totalValueInUsd":"73873.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4474696","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"2ND FLOOR, SERENE CHAMBERS,, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"ATAZANAVIR SULFATE USP (TAX INVOICE NO:U1\/24-25\/EXP\/107 DT:30\/09\/2024)","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":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"343","totalValueFC":"99212.2","currency":"USD","unitRateINR":27788.184066666665,"date":"17-Oct-2024","totalValueINR":"8336455.22","totalValueInUsd":"99212.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4905547","productDescription":"API","marketType":"LESS REGULATED MARKET","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":"Q4","strtotime":1729621800,"product":"ATAZANAVIR SULFATE","address":"2ND FLOOR, SERENE CHAMBERS,","city":"N\/A","supplier":"LAURUS LABS","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"LLC OZON","customerCountry":"RUSSIA","quantity":"240.00","actualQuantity":"240","unit":"KGS","unitRateFc":"543.5","totalValueFC":"129156.9","currency":"USD","unitRateINR":45219.199999999997,"date":"23-Oct-2024","totalValueINR":"10852608","totalValueInUsd":"129156.9","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5058594","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"2ND FLOOR, SERENE CHAMBERS,, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"ATAZANAVIR SULFATE USP","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"LABORATORIOS LEGRAND S.A.ALMINCARGA","customerCountry":"COLOMBIA","quantity":"42.00","actualQuantity":"42","unit":"KGS","unitRateFc":"460","totalValueFC":"18427","currency":"USD","unitRateINR":37024.261904761908,"date":"13-Nov-2024","totalValueINR":"1555019","totalValueInUsd":"18427","indian_port":"Vizag-HIPL SEZ","hs_no":"29333990","bill_no":"5555770","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""}]
    09-Jun-2021
    13-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 300MG BASE;150MG

    USFDA APPLICATION NUMBER - 206353

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    DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21567

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    DOSAGE - CAPSULE;ORAL - EQ 150MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21567

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    DOSAGE - CAPSULE;ORAL - EQ 200MG BASE

    USFDA APPLICATION NUMBER - 21567

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    DOSAGE - CAPSULE;ORAL - EQ 300MG BASE

    USFDA APPLICATION NUMBER - 21567

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    USP

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    ABOUT THIS PAGE

    Atazanavir Sulfate Manufacturers

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

    Atazanavir Sulfate Suppliers

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

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

    Atazanavir Sulfate USDMF

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

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

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

    Atazanavir Sulfate KDMF

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

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

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

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

    Atazanavir Sulfate CEP

    A Atazanavir Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Atazanavir Sulfate Certificate of Suitability (COS). The purpose of a Atazanavir Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atazanavir Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atazanavir Sulfate to their clients by showing that a Atazanavir Sulfate CEP has been issued for it. The manufacturer submits a Atazanavir Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atazanavir Sulfate CEP holder for the record. Additionally, the data presented in the Atazanavir Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atazanavir Sulfate DMF.

    A Atazanavir Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atazanavir Sulfate 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 Atazanavir Sulfate suppliers with CEP (COS) on PharmaCompass.

    Atazanavir Sulfate WC

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

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

    Atazanavir Sulfate 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 Atazanavir Sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Atazanavir Sulfate GMP

    Atazanavir Sulfate 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 Atazanavir Sulfate 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 Atazanavir Sulfate GMP manufacturer or Atazanavir Sulfate GMP API supplier for your needs.

    Atazanavir Sulfate CoA

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

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

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