Synopsis
Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
L02BX03
L02BX03
L02BX03
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-05-05
DMF Number : 28038
Submission : 2014-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28292
Submission : 2014-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26779
Submission : 2012-12-24
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2014-12-23
DMF Number : 28383
Submission : 2014-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-09
Pay. Date : 2022-06-16
DMF Number : 27853
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-06-27
DMF Number : 27829
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-09-06
DMF Number : 27376
Submission : 2013-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-30
Pay. Date : 2014-04-25
DMF Number : 27989
Submission : 2014-02-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-01-10
DMF Number : 26725
Submission : 2012-11-28
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 303MF10054
Registrant's Address : Km. 4.5 Carretera Federal Cuernavaca-Cuautla 62578 Jiutepec, Morelos, Mexico
Initial Date of Registration : 2021-03-30
Latest Date of Registration : 2021-03-30
Registration Number : 304MF10115
Registrant's Address : No. 3 Jiangfeng road, Life and Health Industrial Park, Qidong City 226200, Jiangsu Pr...
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2022-08-03
Registration Number : 304MF10099
Registrant's Address : Badu Industrial Park Zone, Tiantai, Zhejiang province, 317200, P. R. China
Initial Date of Registration : 2022-07-06
Latest Date of Registration : 2025-03-19
Registration Number : 304MF10088
Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...
Initial Date of Registration : 2022-06-22
Latest Date of Registration : 2022-06-22
Registration Number : 304MF10108
Registrant's Address : 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2022-08-03
Registration Number : 301MF10049
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Registration Number : 304MF10100
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2022-07-13
Latest Date of Registration : 2022-07-13
Registration Number : 304MF10113
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2024-10-10
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Brand Name: Abiraterone Acetate-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 19, 2020
Lead Product(s) : Abiraterone Acetate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.
Product Name : Abiraterone Acetate-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 19, 2020
Details:
Abiraterone and the combination product Abiraterone/Prednisolone are used to treat men with prostate cancer. The 500 mg (mono product) and 500 mg + 5 mg (combination product) tablets will be marketed in Europe by our partners.
Lead Product(s): Abiraterone Acetate,Prednisolone
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 17, 2022
Lead Product(s) : Abiraterone Acetate,Prednisolone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abiraterone and the combination product Abiraterone/Prednisolone are used to treat men with prostate cancer. The 500 mg (mono product) and 500 mg + 5 mg (combination product) tablets will be marketed in Europe by our partners.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 17, 2022
Details:
Xaluritamig is a Protein drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): Xaluritamig,Abiraterone Acetate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 09, 2025
Lead Product(s) : Xaluritamig,Abiraterone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xaluritamig is a Protein drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
October 09, 2025
Details:
QLC5508 is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): QLC5508,Abiraterone Acetate,Enzalutamide,QLH12016
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Antibody-drug Conjugate
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 30, 2025
Lead Product(s) : QLC5508,Abiraterone Acetate,Enzalutamide,QLH12016
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : QLC5508 is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
September 30, 2025
Details:
Tulmimetostat is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms, Castration-Sensitive.
Lead Product(s): Tulmimetostat,Darolutamide,Abiraterone Acetate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2025
Lead Product(s) : Tulmimetostat,Darolutamide,Abiraterone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tulmimetostat is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms, Castration-Sensitive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 24, 2025
Details:
Xaluritamig is a Protein drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Prostatic Neoplasms, Castration-Sensitive.
Lead Product(s): Xaluritamig,Darolutamide,Abiraterone Acetate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 26, 2025
Lead Product(s) : Xaluritamig,Darolutamide,Abiraterone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Xaluritamig + AR Pathway Inhibitors Safety & Efficacy in Hormone-sensitive Prostate Cancer
Details : Xaluritamig is a Protein drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Prostatic Neoplasms, Castration-Sensitive.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
August 26, 2025
Details:
QLH12016 is a drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): QLH12016,Abiraterone Acetate,Enzalutamide
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 05, 2025
Lead Product(s) : QLH12016,Abiraterone Acetate,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
QLH12016 with Novel Hormonal Agent in Advanced Prostate Cancer
Details : QLH12016 is a drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 05, 2025
Details:
JSB462 (Luxdegalutamide) is a PROTACs drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): Luxdegalutamide,Abiraterone Acetate
Therapeutic Area: Oncology Brand Name: JSB462
Study Phase: Phase IIProduct Type: PROTACs
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 28, 2025
Lead Product(s) : Luxdegalutamide,Abiraterone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
JSB462 + Abiraterone Safety and Efficacy In mHSPC Adults
Details : JSB462 (Luxdegalutamide) is a PROTACs drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.
Product Name : JSB462
Product Type : PROTACs
Upfront Cash : Inapplicable
May 28, 2025
Details:
ORIC intends to use the net proceeds to fund research and development of its clinical-stage product candidates, including ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2.
Lead Product(s): ORIC-944,Abiraterone Acetate,Apalutamide
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: SR One
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement May 28, 2025
Lead Product(s) : ORIC-944,Abiraterone Acetate,Apalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : SR One
Deal Size : $125.0 million
Deal Type : Private Placement
ORIC Pharmaceuticals Announces $125 Million Private Placement Financing
Details : ORIC intends to use the net proceeds to fund research and development of its clinical-stage product candidates, including ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 28, 2025
Details:
The proceeds will support advancement of the company’s clinical-stage pipeline, which includes FT-7051 (pocenbrodib) is being evaluated for metastatic castration-resistant prostate cancer.
Lead Product(s): Pocenbrodib,Abiraterone Acetate,Olaparib
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: $365.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing May 15, 2025
Lead Product(s) : Pocenbrodib,Abiraterone Acetate,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $365.0 million
Deal Type : Series D Financing
Pathos AI Raises $365M Series D to Boost Oncology Drug Discovery via AI
Details : The proceeds will support advancement of the company’s clinical-stage pipeline, which includes FT-7051 (pocenbrodib) is being evaluated for metastatic castration-resistant prostate cancer.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 15, 2025
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 202379
DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 202379
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Granulation
Direct Compression
Lubricants & Glidants
Disintegrants & Superdisintegrants
Controlled & Modified Release
Thickeners and Stabilizers
Co-Processed Excipients
Solubilizers
Film Formers & Plasticizers
Parenteral
Taste Masking
Emulsifying Agents
Chewable & Orodispersible Aids
API Stability Enhancers
Coloring Agents
Topical
Rheology Modifiers
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
90
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 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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
