Molecules / Abiraterone

Abiraterone API manufacturers

CAS 154229-19-3 ATC L02BX03 Updated 9 July 2026
22
manufacturers with an active filing 21 of them hold a US DMF or a CEP
$1276.44
median export price per kg $1097.18 to $1500.00 · 6 exporters · 2025
20
shortage records on file across 3 countries
642
finished-dose makers across 48 regulators
Showing 20 of 22 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Dr. Reddy's Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for abiraterone, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Raks Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2014. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Cipla

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Shilpa Pharma Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Industriale Chimica

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for abiraterone, filing since 2014. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2022. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2023. Its 2023 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Sterling

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2012. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Olon

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Aurisco Pharmaceutical Co.,Ltd

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for abiraterone, filing since 2017. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Shandong Anhong Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2018. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Tianjin Weijie Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2017. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Zach System

France
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2014. Its 2021 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Zhejiang Shenzhou Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2021. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Cdymax (India) Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2022. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Sterling Chemical Malta

Malta
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for abiraterone, filing since 2014. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

19 more manufacturers hold filings for abiraterone

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Raks PharmaCiplaShilpa Pharma LifesciencesHubei Biocause Heilen PharmaceuticalIndustriale ChimicaApitoria PharmaHubei Zhuxi Humanwell PharmaceuticalSterlingOlonAurisco Pharmaceutical Co.,LtdShandong Anhong PharmaceuticalTianjin Weijie PharmaceuticalZach SystemZhejiang Shenzhou PharmaceuticalCdymax (India) PharmaSterling Chemical MaltaAlp Pharm Beijing
Open the full list with a free account

Contract manufacturers (8)

Dr. Reddy's Laboratories India Shilpa Pharma Lifesciences India Aurisco Pharmaceutical Co.,Ltd China Hubei Biocause Heilen Pharmaceutical China Pinnacle Life Science India Biozenta Oncology India Onko İlaç Sanayi̇ Veti̇caret A.Ş Turkey Surya Life Sciences India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (58)

Glenmark Pharmaceuticals s.r.o Czech Republic Apotex Canada Zentiva, k.s Czech Republic Natco Pharma India Pharmascience Canada Sandoz Switzerland Mylan Pharmaceuticals United States Olpha Latvia Teva Israel Viatris United States Rising United States Zydus Lifesciences India BDR Lifesciences India Aizant Drug Research Solutions India Alembic Pharmaceuticals India Cosmo Italy Eurofarma Laboratorios Brazil Jamp Pharma Canada Medac Gesellschaft für klinische Spezialpräparate mbH; Germany Patheon France S.A.S France

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 2 yrs Shortages 20 Recalls 1 Finished dose 58 Contract mfrs 8

By country

China 14 India 13 Italy 6

Export price by year

Year Median Exporters
2025 $1276.44 6
2024 $1574.48 6

US dollars per kilogram, customs export unit values.