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1. 17-(3-pyridyl)-5,16-androstadien-3beta-acetate
2. Cb 7630
3. Cb-7630
4. Cb7630
5. Zytiga
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
| Molecular Weight | 391.5 g/mol |
|---|---|
| Molecular Formula | C26H33NO2 |
| XLogP3 | 5.2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 391.251129295 g/mol |
| Monoisotopic Mass | 391.251129295 g/mol |
| Topological Polar Surface Area | 39.2 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 739 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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.
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.)
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L02BX03
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DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 202379
DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 202379
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PharmaCompass offers a list of Abiraterone Acetate 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 Abiraterone Acetate manufacturer or Abiraterone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Abiraterone Acetate manufacturer or Abiraterone Acetate supplier.
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.
A Zytiga manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zytiga, including repackagers and relabelers. The FDA regulates Zytiga manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zytiga 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 Zytiga manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zytiga supplier is an individual or a company that provides Zytiga active pharmaceutical ingredient (API) or Zytiga finished formulations upon request. The Zytiga suppliers may include Zytiga API manufacturers, exporters, distributors and traders.
click here to find a list of Zytiga suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zytiga DMF (Drug Master File) is a document detailing the whole manufacturing process of Zytiga active pharmaceutical ingredient (API) in detail. Different forms of Zytiga DMFs exist exist since differing nations have different regulations, such as Zytiga USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zytiga DMF submitted to regulatory agencies in the US is known as a USDMF. Zytiga USDMF includes data on Zytiga's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zytiga USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zytiga suppliers with USDMF on PharmaCompass.
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 Zytiga Drug Master File in Japan (Zytiga JDMF) empowers Zytiga 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 Zytiga JDMF during the approval evaluation for pharmaceutical products. At the time of Zytiga 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 Zytiga suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Zytiga Drug Master File in Korea (Zytiga KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zytiga. The MFDS reviews the Zytiga KDMF as part of the drug registration process and uses the information provided in the Zytiga KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zytiga 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 Zytiga API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zytiga suppliers with KDMF on PharmaCompass.
A Zytiga written confirmation (Zytiga WC) is an official document issued by a regulatory agency to a Zytiga manufacturer, verifying that the manufacturing facility of a Zytiga active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zytiga APIs or Zytiga finished pharmaceutical products to another nation, regulatory agencies frequently require a Zytiga WC (written confirmation) as part of the regulatory process.
click here to find a list of Zytiga suppliers with Written Confirmation (WC) on PharmaCompass.
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 Zytiga as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zytiga API and other APIs are published in this directory by the FDA.
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 Zytiga 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.
The NDC directory also contains data on finished compounded human drug products that contain Zytiga and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zytiga NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zytiga suppliers with NDC on PharmaCompass.
Zytiga 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 Zytiga 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 Zytiga GMP manufacturer or Zytiga GMP API supplier for your needs.
A Zytiga CoA (Certificate of Analysis) is a formal document that attests to Zytiga's compliance with Zytiga specifications and serves as a tool for batch-level quality control.
Zytiga CoA mostly includes findings from lab analyses of a specific batch. For each Zytiga 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.
Zytiga may be tested according to a variety of international standards, such as European Pharmacopoeia (Zytiga EP), Zytiga JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zytiga USP).
