Molecules / Oxandrolone

Oxandrolone API manufacturers

CAS 53-39-4 ATC A14AA08 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
6
finished-dose makers across 3 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

HIKMA ITALIA

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

Holds one active US DMF for oxandrolone, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.

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

Novitium Pharma

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

Holds 2 active US DMFs for oxandrolone, filing since 2017. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 4 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Siegfried

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

Holds one active US DMF for oxandrolone, filing since 2003. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Trifarma

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

Holds one active US DMF for oxandrolone, filing since 2005. 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
05

Curia

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

Holds one active US DMF for oxandrolone, filing since 2020.

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 oxandrolone

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

TrifarmaCuria
Open the full list with a free account

Finished-dose makers (2)

Alpha Pharma Healthcare (1) India Sandoz Switzerland

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

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Also on this molecule

Recalls 2 Finished dose 2 Contract mfrs 0