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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


KDMF

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01

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Abiraterone acetate

Registrant Name : Alvogen Korea Co., Ltd.

Registration Date : 2025-05-23

Registration Number : No. 105-2-ND(A)

Manufacturer Name : Aurisco Pharmaceutical Co.,L...

Manufacturer Address : Badu Industrial Park Zone, Tiantai, Zhejiang Province 317200, PR China

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02

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Abiraterone acetate

Registrant Name : Ace Pharma Co., Ltd.

Registration Date : 2024-02-29

Registration Number : Su105-2-ND

Manufacturer Name : Aurisco Pharmaceutical Co.,L...

Manufacturer Address : Badu Industrial Park Zone, Tiantai, Zhejiang Province 317200, PR China

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03

Hetero Drugs

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India
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Micronized abiraterone acetate

Registrant Name : Hoosung Bio Co., Ltd.

Registration Date : 2025-02-05

Registration Number : Thu21-22-ND(2)

Manufacturer Name : Hetero Labs Limited Unit-1

Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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Abiraterone acetate

Registrant Name : Hanmi Pharmaceutical Co., Ltd.

Registration Date : 2023-03-03

Registration Number : Thu21-22-ND(1)

Manufacturer Name : Hetero Labs Limited Unit-I

Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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Hetero Drugs

India
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Abiraterone acetate

Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2022-12-05

Registration Number : Thu21-22-ND

Manufacturer Name : Hetero Labs Limited Unit-I

Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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06

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Abiraterone acetate

Registrant Name : Sungjin Exim Co., Ltd.

Registration Date : 2023-05-16

Registration Number : Number 133-14-ND

Manufacturer Name : Hubei Biocause Heilen Pharma...

Manufacturer Address : 122 Yangwan Road, Jingmen City, Hubei Province, 448000 PRChina

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07

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Abiraterone acetate

Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2022-08-10

Registration Number : 69-13-ND

Manufacturer Name : Industriale Chimica SRL@IMS ...

Manufacturer Address : Via EH Grieg, 13-21047 SARONNO(VA)@Via Venezia Giulia 23, 20157 Milano

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08

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Abiraterone acetate

Registrant Name : Korea Janssen Co., Ltd.

Registration Date : 2015-06-04

Registration Number : No. 4945-22-ND

Manufacturer Name : Janssen Pharmaceutica NV

Manufacturer Address : Janssen Pharmaceuticalaan 3, Geel, B-2440, Belgium

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Micronized abiraterone acetate

Registrant Name : Sampoong Pharmachem Co., Ltd.

Registration Date : 2023-10-27

Registration Number : No. 582-12-ND

Manufacturer Name : Shandong Anhong Pharmaceutic...

Manufacturer Address : No. 29 Huayuan Street Linyi County, Dezhou, Shandong, China

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10

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Abiraterone acetate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2021-06-07

Registration Number : Su207-50-ND

Manufacturer Name : Sicor de Mexico SA de CV

Manufacturer Address : Av. San Rafael No. 35, Parque Ind. Lerma, CP 52000, Mpio, Lerma, Mexico

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03-Feb-2022
30-May-2025
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PharmaCompass also assists you with knowing the Abiraterone Acetate API Price utilized in the formulation of products. Abiraterone Acetate API Price is not always fixed or binding as the Abiraterone Acetate Price is obtained through a variety of data sources. The Abiraterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Abiraterone Acetate

Synonyms

154229-18-2, Zytiga, Cb7630, Cb-7630, Yonsa, Cb 7630

Cas Number

154229-18-2

Unique Ingredient Identifier (UNII)

EM5OCB9YJ6

About 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.

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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