Molecules / Testosterone Undecanoate

Testosterone Undecanoate API manufacturers

CAS 5949-44-0 ATC G03BA03 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
6
shortage records on file across 2 countries
131
finished-dose makers across 16 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bayer S/A

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

Holds one active US DMF for testosterone undecanoate, filing since 2003. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.

US DMF
1 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
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02
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for testosterone undecanoate, filing since 2024. 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
03

Symbiotec Pharmalab

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

Holds one active US DMF for testosterone undecanoate, filing since 2011. 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
04

Aspen Oss

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

Holds one active US DMF for testosterone undecanoate, filing since 1999.

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
05

Steroid

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

Holds one active US DMF for testosterone undecanoate, filing since 2013.

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

2 more manufacturers hold filings for testosterone undecanoate

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

Aspen OssSteroid
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Finished-dose makers (16)

Taro Pharmaceuticals Israel Ever Pharma Jena Germany Tolmar United States Bayer HealthCare United States Delta Pharma Pakistan Laboratoires Besins International France Adcock Ingram South Africa Bayer Germany Acdima International Trading Egypt Marcyrl Pharmaceutical Industries Egypt Grünenthal Germany Alliance Pharmaceuticals Pakistan Dermapharm Germany Laboratorio Farmaceutico S.I.T. - Specialita Igienico Terapeutiche Italy Besins Healthcare Brazil Ever Valinject Austria

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

Who makes testosterone undecanoate?

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

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Also on this molecule

Shortages 6 Recalls 2 Finished dose 16 Contract mfrs 0