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    Chemistry

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    Also known as: 154229-18-2, Zytiga, Cb7630, Cb-7630, Yonsa, Cb 7630
    Molecular Formula
    C26H33NO2
    Molecular Weight
    391.5  g/mol
    InChI Key
    UVIQSJCZCSLXRZ-UBUQANBQSA-N
    FDA UNII
    EM5OCB9YJ6
    Abiraterone Acetate
    An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.
    1 2D Structure

    Abiraterone Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate
    2.1.2 InChI
    InChI=1S/C26H33NO2/c1-17(28)29-20-10-12-25(2)19(15-20)6-7-21-23-9-8-22(18-5-4-14-27-16-18)26(23,3)13-11-24(21)25/h4-6,8,14,16,20-21,23-24H,7,9-13,15H2,1-3H3/t20-,21-,23-,24-,25-,26+/m0/s1
    2.1.3 InChI Key
    UVIQSJCZCSLXRZ-UBUQANBQSA-N
    2.1.4 Canonical SMILES
    CC(=O)OC1CCC2(C3CCC4(C(C3CC=C2C1)CC=C4C5=CN=CC=C5)C)C
    2.1.5 Isomeric SMILES
    CC(=O)O[C@H]1CC[C@@]2([C@H]3CC[C@]4([C@H]([C@@H]3CC=C2C1)CC=C4C5=CN=CC=C5)C)C
    2.2 Other Identifiers
    2.2.1 UNII
    EM5OCB9YJ6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 17-(3-pyridyl)-5,16-androstadien-3beta-acetate

    2. Cb 7630

    3. Cb-7630

    4. Cb7630

    5. Zytiga

    2.3.2 Depositor-Supplied Synonyms

    1. 154229-18-2

    2. Zytiga

    3. Cb7630

    4. Cb-7630

    5. Yonsa

    6. Cb 7630

    7. Abiraterone Acetate [usan]

    8. 17-(3-pyridyl)-5,16-androstadien-3beta-acetate

    9. Em5ocb9yj6

    10. [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Acetate

    11. Nsc-748121

    12. Nsc-749227

    13. Chebi:68639

    14. (3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-(pyridin-3-yl)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1h-cyclopenta[a]phenanthren-3-yl Acetate

    15. 17-(pyridin-3-yl)androsta-5,16-dien-3beta-yl Acetate

    16. (3beta)-17-(pyridin-3-yl)androsta-5,16-dien-3-yl Acetate

    17. Abiraterone Acotate

    18. 17-(3-pyridyl)androsta-5, Acetate

    19. Androsta-5, 17-(3-pyridinyl)-, 3-acetate,

    20. Unii-em5ocb9yj6

    21. Abiraterone-acetate

    22. Ncgc00186462-01

    23. 3s,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-ol, 3-acetate

    24. Abiraterone Acetate

    25. Mfcd00934213

    26. Zytiga (tn)

    27. Abiraterone (acetate)

    28. Jnj-212082

    29. Abiraterone Acetate- Bio-x

    30. Dsstox_cid_28969

    31. Dsstox_rid_83234

    32. Dsstox_gsid_49043

    33. Schembl93715

    34. Mls006010090

    35. Chembl271227

    36. Gtpl9288

    37. Abiraterone Acetate (jan/usp)

    38. 3beta-17-(3-pyridyl)androsta-5,16-dien-3-ol Acetate

    39. Abiraterone (as Acetate)

    40. Abiraterone Acetate [mi]

    41. Dtxsid3049043

    42. Abiraterone Acetate [jan]

    43. Ex-a107

    44. Abiraterone Acetate [vandf]

    45. Abiraterone Acetate [mart.]

    46. Bcp02949

    47. Zinc3809191

    48. Tox21_113589

    49. Abiraterone Acetate [usp-rs]

    50. Abiraterone Acetate [who-dd]

    51. Bdbm50407398

    52. Nsc748121

    53. Nsc749227

    54. S2246

    55. Abiraterone Acetate, >=98% (hplc)

    56. Akos015896502

    57. Cs-0544

    58. Ds-2007

    59. Jnj 212082

    60. Nsc 748121

    61. Nsc 749227

    62. Jnj-2012082

    63. Abiraterone Acetate [orange Book]

    64. Ncgc00379022-06

    65. Ac-25760

    66. Ba164133

    67. Hy-75054

    68. Smr004701235

    69. Abiraterone Acetate [usp Monograph]

    70. Cas-154229-18-2

    71. D09701

    72. 3b-acetoxy-17-(3-pyridyl)androsta-5,16-diene

    73. A809510

    74. 3beta-acetoxy-17-(3-pyridyl)androsta-5,16-diene

    75. W-201385

    76. Brd-k24048528-001-02-5

    77. Q27888393

    78. (3s)-3-acetoxy-17-(pyridin-3-yl)androsta-5,16-diene

    79. (3?)-17-(3-pyridinyl)androsta-5,16-dien-3-yl Acetate

    80. (3beta)-17-(3-pyridinyl)androsta-5,16-dien-3-ol Acetate

    81. 17-(pyridin-3-yl)androsta-5,16-dien-3.beta.-yl Acetate

    82. Abiraterone Acetate, United States Pharmacopeia (usp) Reference Standard

    83. Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, Acetate (ester), (3beta)-

    84. Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, Acetate (ester), (3.beta.)-

    85. (1s,2r,5s,10r,11s,15s)-2,15-dimethyl-14-(pyridin-3-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-7,13-dien-5-yl Acetate

    86. [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Ethanoate

    87. Acetic Acid [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-(3-pyridinyl)-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Ester

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 391.5 g/mol
    Molecular Formula C26H33NO2
    XLogP35.2
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass391.251129295 g/mol
    Monoisotopic Mass391.251129295 g/mol
    Topological Polar Surface Area39.2 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity739
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Zytiga is indicated with prednisone or prednisolone for:

    - the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

    - the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

    Abiraterone Mylan is indicated with prednisone or prednisolone for:

    - the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

    - the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

    - the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

    Abiraterone Krka is indicated with prednisone or prednisolone for:

    - the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5. 1)

    - the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)

    - the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Cytochrome P-450 Enzyme Inhibitors

    Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 ENZYMES. (See all compounds classified as Cytochrome P-450 Enzyme Inhibitors.)

    Steroid Synthesis Inhibitors

    Compounds that bind to and inhibit enzymes involved in the synthesis of STEROIDS. (See all compounds classified as Steroid Synthesis Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cytochrome P450 17A1 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 17A1 Inhibitor [EPC]
    5.3 ATC Code

    L02BX03

    L02BX03

    L02BX03

    API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"252.00","actualQuantity":"252","unit":"KGS","unitRateFc":"1150","totalValueFC":"292122.7","currency":"USD","unitRateINR":"98497.5","date":"17-Dec-2024","totalValueINR":"24821370","totalValueInUsd":"292122.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"7290458","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"PUDONG\/SHANGHAI, 31","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"ABIRATERONE ACETATE USP MICRONIZED SPEC1","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"N\/A","supplierCountry":"MEXICO","foreign_port":"CIUDAD DE M\u00c9XICO, DIF","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"172.00","actualQuantity":"172","unit":"KGS","unitRateFc":"5504.9","totalValueFC":"957767.7","currency":"USD","unitRateINR":"473142.8","date":"27-Dec-2024","totalValueINR":"81380554","totalValueInUsd":"957767.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"7484487","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Micronized","supplierPort":"CIUDAD DE M\u00c9XICO, DIF","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"ABIRATERONE ACETATE USP MICRONIZED SPEC1","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"N\/A","supplierCountry":"MEXICO","foreign_port":"CIUDAD DE M\u00c9XICO, DIF","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"29.00","actualQuantity":"29","unit":"KGS","unitRateFc":"5430.2","totalValueFC":"159294.1","currency":"USD","unitRateINR":"466726.3","date":"27-Dec-2024","totalValueINR":"13535062","totalValueInUsd":"159294.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"7484487","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Micronized","supplierPort":"CIUDAD DE M\u00c9XICO, DIF","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
    04-Jan-2021
    27-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 250MG

    USFDA APPLICATION NUMBER - 202379

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    DOSAGE - TABLET;ORAL - 500MG

    USFDA APPLICATION NUMBER - 202379

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    ABOUT THIS PAGE

    Abiraterone Acetate Manufacturers

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

    Abiraterone Acetate Suppliers

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

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

    Abiraterone Acetate USDMF

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

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

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

    Abiraterone Acetate JDMF

    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 Abiraterone Acetate Drug Master File in Japan (Abiraterone Acetate JDMF) empowers Abiraterone Acetate 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 Abiraterone Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Abiraterone Acetate 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 Abiraterone Acetate suppliers with JDMF on PharmaCompass.

    Abiraterone Acetate KDMF

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

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

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

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

    Abiraterone Acetate WC

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

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

    Abiraterone Acetate 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 Abiraterone Acetate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Abiraterone Acetate GMP

    Abiraterone Acetate 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 Abiraterone Acetate 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 Abiraterone Acetate GMP manufacturer or Abiraterone Acetate GMP API supplier for your needs.

    Abiraterone Acetate CoA

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

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

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