Molecules / Methadone / United States

Methadone API manufacturers in United States

CAS 76-99-3 ATC N07BC02 Updated 9 July 2026
5
United States-based manufacturers with an active filing of 8 worldwide
Showing 3 of 5 United States-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked United States-based API manufacturers

01

Siegfried

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

Holds one active US DMF for methadone, filing since 1986. 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
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02

Specgx

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

Holds 2 active US DMFs for methadone, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Chattem Chemicals

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

Holds one active US DMF for methadone, filing since 2012. Its 2022 FDA inspection closed as NAI.

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

2 more manufacturers in United States hold filings for methadone

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

SpecgxChattem Chemicals
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How this list is built

This page filters the worldwide Methadone manufacturer list to companies based in United States. 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. Read the full method.

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All Methadone manufacturers

Worldwide 8