Molecules / Codeine / United States

Codeine API manufacturers in United States

CAS 76-57-3 ATC R05DA04 Updated 9 July 2026
7
United States-based manufacturers with an active filing of 28 worldwide
Showing 5 of 7 United States-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked United States-based API manufacturers

01

Specgx

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

Holds 2 active US DMFs and one valid CEP for codeine, filing since 1983. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Siegfried USA

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

Holds one active US DMF for codeine, filing since 2007. 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
03

Chattem Chemicals

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

Holds one active US DMF for codeine, filing since 2022. 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
04

Noramco

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

Holds one active US DMF for codeine, filing since 2012. 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
05

Veranova Lp

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

Holds one active US DMF for codeine, filing since 2007.

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 in United States hold filings for codeine

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

NoramcoVeranova Lp
Open the full list with a free account

How this list is built

This page filters the worldwide Codeine 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 Codeine manufacturers

Worldwide 28