Molecules / Buprenorphine

Buprenorphine API manufacturers

CAS 52485-79-7 ATC N02AE01 Updated 9 July 2026
16
manufacturers with an active filing 15 of them hold a US DMF or a CEP
71
shortage records on file across 6 countries
415
finished-dose makers across 40 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Specgx

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.

US DMF
2 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
06

indivior uk

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

Holds one active US DMF for buprenorphine, filing since 1997. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Rusan Pharma

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

Holds 2 valid CEPs for buprenorphine, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
11 markets
08

Unichem Laboratories

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

Holds one valid CEP for buprenorphine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
09

Chattem Chemicals

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.

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
10

Cambrex Charles City

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.

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
11

Noramco

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.

US DMF
4 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
12

Aspen Oss

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

Holds one active US DMF for buprenorphine, filing since 1987.

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
13

Azad Pharma

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

Holds 2 valid CEPs for buprenorphine, filing since 2025. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
16

Siegfried PharmaChemikalien Minden

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for buprenorphine. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Contract manufacturers (3)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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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Sold in these combinations

Fixed-dose combinations containing buprenorphine. Each page leads with the verified API makers of every component.