Ranked United States-based API manufacturers
01 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 4 valid CEPs for buprenorphine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
02 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for buprenorphine, filing since 2021. Its 2022 FDA inspection closed as NAI.
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
03 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for buprenorphine, filing since 2023. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
04 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for buprenorphine, filing since 2010. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
3 more manufacturers in United States hold filings for buprenorphine
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account How this list is built
This page filters the worldwide Buprenorphine 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.