Molecules / Hydromorphone / United States

Hydromorphone API manufacturers in United States

CAS 466-99-9 ATC N02AA03 Updated 9 July 2026
5
United States-based manufacturers with an active filing of 10 worldwide
Showing 5 of 5 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 APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for hydromorphone, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 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
02

Siegfried

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

Holds one active US DMF for hydromorphone, filing since 2008. 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

Noramco

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

Holds one active US DMF for hydromorphone, filing since 2006. 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
04

Chattem Chemicals

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

Holds one active US DMF for hydromorphone, filing since 2016. 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
05

Veranova Lp

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

Holds one active US DMF for hydromorphone, filing since 2006.

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

How this list is built

This page filters the worldwide Hydromorphone 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 Hydromorphone manufacturers

Worldwide 10

Also made in United States

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All API manufacturers in United States