Who makes naloxone + buprenorphine?

Naloxone + Buprenorphine is a fixed-dose combination of Naloxone and Buprenorphine. There is no combination-level drug master file; it is sourced as a finished combination or built from its component APIs. 10 verified finished-combination manufacturers are listed, 3 with a matched US, EU or WHO-PQ combination approval.

Where do the APIs in naloxone + buprenorphine come from?

Naloxone: 12 verified API manufacturers. Buprenorphine: 18 verified API manufacturers. Each links to its own ranked supplier page.

What strengths does naloxone + buprenorphine come in?

Common marketed ratios include 2/0, 8/2, 2/2, 8/8, 4/1 (mg per component). Ratios come from the finished-product records as at 29 July 2026.

Naloxone + Buprenorphine FDC manufacturers

Component APIs — where each ingredient comes from

Naloxone API manufacturers

12 verified API manufacturers

Specgx · 1 US DMF, 1 CEP

Macfarlan Smith · 1 US DMF, 1 CEP

Siegfried PharmaChemikalien Minden · 2 US DMF, 1 CEP

Rusan Pharma · 1 CEP

Siegfried · 1 US DMF

All 12 Naloxone makers →

Buprenorphine API manufacturers

18 verified API manufacturers

Siegfried · 4 US DMF, 2 CEP

Specgx · 2 US DMF, 4 CEP

Arevipharma · 3 US DMF, 4 CEP

Macfarlan Smith · 1 US DMF, 2 CEP

Chr. Olesen Synthesis A/S · 1 US DMF, 2 CEP

All 18 Buprenorphine makers →

Finished-combination manufacturers

Companies with a filed naloxone + buprenorphine finished product. Approval reach is reconciled against the FDA Orange Book, EMA and WHO-PQ.