Molecules / Testosterone

Testosterone API manufacturers

CAS 58-22-0 ATC G03BA03 Updated 9 July 2026
15
manufacturers with an active filing 14 of them hold a US DMF or a CEP
$457.60
median export price per kg $352.71 to $654.98 · 23 exporters · 2025
85
shortage records on file across 5 countries
333
finished-dose makers across 44 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

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 testosterone, filing since 2010. 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
02

Bayer S/A

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

Holds 2 active US DMFs for testosterone, filing since 2000. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
46 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Lupin

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

Holds one active US DMF for testosterone, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

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

Bayer

Germany
Makes the APIFinished dose

Holds 2 valid CEPs for testosterone, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
22 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
05

Curia Spain S.A.U

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

Holds one active US DMF for testosterone, filing since 2018. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for testosterone, filing since 2022. 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
07

Symbiotec Pharmalab

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

Holds 5 active US DMFs for testosterone, filing since 2011. Its 2022 FDA inspection closed as VAI.

US DMF
5 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
08

Trifarma

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

Holds one active US DMF for testosterone, filing since 2007. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Aspen Oss

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

Holds one active US DMF for testosterone, filing since 1996.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Hubei Goto Biopharm

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

Holds one active US DMF for testosterone, filing since 2017.

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

Hubei Goto Biotechnology

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

Holds one active US DMF for testosterone, filing since 2018.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

PHARMACIA & UPJOHN

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

Holds one valid CEP for testosterone, filing since 2021.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
14

Steroid

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

Holds one valid CEP for testosterone, filing since 2022.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
15

Registered with SFDA (Saudi Arabia) for testosterone.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

12 more manufacturers hold filings for testosterone

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

BayerCuria Spain S.A.UHubei Zhuxi Humanwell PharmaceuticalSymbiotec PharmalabTrifarmaAspen OssHubei Goto BiopharmHubei Goto BiotechnologyPHARMACIA & UPJOHNzhejiang xianju pharmaceuticalSteroidProductos Quimicos Naturales S.A. de
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Contract manufacturers (8)

Bayer Germany Hubei Gedian humanwell Pharmaceutical China Symbiotica Speciality Ingredients Sdn.Bhd Malaysia Shree Venkatesh International India Jiangsu Jiaerke Pharmaceuticals Group China Hubei Goto Biopharm China Aspen API Netherlands Chengdu Okay Pharmaceutical China

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

Finished-dose makers (49)

Laboratoires Besins International France Teva Israel Cipla India Alembic Pharmaceuticals India Delpharm Montréal Canada Strides Pharma Science India Abbvie United States Apotex Canada Encube Ethicals India Eli Lilly Italia Italy Labdhi Pharmaceuticals India Laboratorios Recalcine Chile Ferring Germany Gilead Sciences United States Taro Pharmaceuticals Israel Besins Healthcare Brazil Amneal Pharmaceuticals NY United States Bayer De Mexico, S.A. De C.V Mexico Casa Rubio S.A.C.I.F Argentina Argentina Eli Lilly And United States

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.

Who makes testosterone?

Ask Fred which manufacturers are on record for testosterone and what filings they hold.

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Also on this molecule

Price history 4 yrs Shortages 85 Recalls 113 Finished dose 49 Contract mfrs 8

Export price by year

Year Median Exporters
2025 $457.60 23
2024 $563.50 13
2023 $387.50 7
2022 $749.99 9

US dollars per kilogram, customs export unit values.