Opioid Antagonist, Partial Opioid Agonist
Where is Buprenorphine and Naloxone made?
19 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 17 factories in the United States, the United Kingdom, India and Switzerland.
United States 11United Kingdom 3India 2Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Indivior Inc. Suboxone1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 12496-1204, 12496-1202, 12496-1208 +1 | Aquestive TherapeuticsMakes it, tests it and packages it | Portage, IN, United States | Problems found, fixed voluntarilyJan 2025 |
| INDIVIOR UK LimitedMakes the active ingredient and tests it | Hull, United Kingdom | Problems found, fixed voluntarilySep 2021 | |
| Macfarlan Smith LimitedMakes the active ingredient | Edinburgh, United Kingdom | Problems found, fixed voluntarilyNov 2021 | |
| Siegfried AGMakes the active ingredient and tests it | Zofingen, Switzerland | Problems found, fixed voluntarilyFeb 2025 | |
| SpecGx LLCMakes the active ingredient and tests it | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| Veranova, L.P.Makes the active ingredient | West Deptford, NJ, United States | Problems found, fixed voluntarilyJan 2026 | |
| Dr. Reddy's Laboratories Inc.1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 43598-580, 43598-579, 43598-582 +1 | LTS Lohmann Therapy Systems Corp.Makes it and tests it | West Caldwell, NJ, United States | No problems foundFeb 2024 |
| Pharmaron Manufacturing Services (UK) LimitedMakes the active ingredient | Cramlington, United Kingdom | Problems found, fixed voluntarilyFeb 2022 | |
| Rhodes Pharmaceuticals L.P.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 42858-601, 42858-602 | Halo Pharmaceutical IncMakes it | Whippany, NJ, United States | No problems foundDec 2025 |
| Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 | |
| Accord Healthcare Inc.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 16729-549, 16729-550 | Wes Pharma IncMakes it | Westminster, MD, United States | Problems found, fixed voluntarilyNov 2025 |
| Ascend Laboratories, LLC2 mg / 0.5 mg, 2 mg / 8 mg · NDC 67877-607, 67877-606 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aveva Drug Delivery Systems Inc.1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 3215-6522, 3215-6521, 3215-6523 +1 | Aveva Drug Delivery Systems Inc.Makes it and tests it | Miramar, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Camber Pharmaceuticals Inc.1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 31722-480, 31722-850, 31722-479 +3 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 62756-969, 62756-970 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Hikma Pharmaceuticals USA Inc.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 0054-0188, 0054-0189 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Ingenus Pharmaceuticals, LLC1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 50742-398, 50742-397, 50742-364 +1 | Aveva Drug Delivery Systems Inc.Makes it and tests it | Miramar, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Lannett Company, Inc.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 62175-452, 62175-458 | Lannett Company, LLCMakes it, tests it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Actavis Pharma, Inc.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 0228-3154, 0228-3155 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Alvogen Inc.1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 47781-356, 47781-355, 47781-357 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals2 mg / 0.5 mg, 2 mg / 8 mg · NDC 65162-416, 65162-415 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Edenbridge Pharmaceuticals LLC. Zubsolv0.7 mg / 0.18 mg, 1.4 mg / 0.36 mg, 1.4 mg / 5.7 mg, 2.1 mg / 8.6 mg, 2.9 mg / 0.71 mg, 2.9 mg / 11.4 mg · NDC 82111-201, 82111-202, 82111-204 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.1 mg / 4 mg, 2 mg / 0.5 mg, 2 mg / 8 mg, 3 mg / 12 mg · NDC 0378-8766, 0378-8765, 0378-8767 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Orexo US, Inc. Zubsolv0.7 mg / 0.18 mg, 1.4 mg / 0.36 mg, 1.4 mg / 5.7 mg, 2.1 mg / 8.6 mg, 2.9 mg / 0.71 mg, 2.9 mg / 11.4 mg · NDC 54123-907, 54123-914, 54123-957 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.2 mg / 0.5 mg, 2 mg / 8 mg · NDC 0121-1018, 0121-2036 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SpecGx LLC2 mg / 0.5 mg, 2 mg / 8 mg · NDC 0406-8005, 0406-8020 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Buprenorphine and Naloxone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Aidarex Pharmaceuticals LLC:
53217-138,53217-328 - American Health Packaging:
60687-626,60687-637 - Asclemed USA, Inc.:
76420-534 - AvPAK:
50268-144,50268-145 - Bryant Ranch Prepack:
63629-7269,71335-1653,71335-1720,63629-9482+11 - Clinical Solutions Wholesale:
58118-8005,58118-0549,58118-1188,58118-8020+1 - Golden State Medical Supply, Inc.:
51407-948,51407-949 - Major Pharmaceuticals:
0904-7009,0904-7010 - Physicians Total Care, Inc.:
54868-5750,54868-5707 - RedPharm Drug. Inc.:
67296-2063,67296-2228,67296-1877,67296-2164+3 - Remedyrepack Inc.:
70518-3862,70518-3389,70518-3844 - Unit Dose Solutions, Inc.:
87441-003,87441-001,87441-002
Recalls
- Oct 18, 2022 · Class II · Sun Pharmaceutical Industries Inc
Presence of Foreign Substance - Feb 26, 2021 · Class II · Alvogen, Inc
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.