Partial Opioid Agonist
Where is Buprenorphine made?
24 companies sell it under their own name and 15 repackagers rebottle it. Their labels name 16 factories in the United States, India, the United Kingdom and Germany.
United States 8India 4United Kingdom 3Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Indivior Inc. Sublocade100 mg, 300 mg · NDC 12496-0100, 12496-0300 | Curia New Mexico, LLCMakes it | Albuquerque, NM, United States | Problems found, fixed voluntarilyJun 2024 |
| INDIVIOR UK LimitedMakes the active ingredient and tests it | Hull, United Kingdom | Problems found, fixed voluntarilySep 2021 | |
| Sterling Pharma Solutions LimitedMakes the active ingredient and tests it | Cramlington, United Kingdom | Problems found, fixed voluntarilyJul 2025 | |
| Rhodes Pharmaceuticals L.P.2 mg, 5 ug per 1 h, 7.5 ug per 1 h, 8 mg, 10 ug per 1 h, 15 ug per 1 h · NDC 42858-493, 42858-586, 42858-501 +4 | Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 |
| LTS Lohmann Therapie-Systeme AGMakes it | Andernach, Germany | No problems foundMay 2022 | |
| LTS Lohmann Therapy Systems Corp.Makes it | West Caldwell, NJ, United States | No problems foundFeb 2024 | |
| Hospira, Inc.0.3 mg per 1 mL · NDC 0409-2012 | Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 |
| Macfarlan Smith LimitedMakes the active ingredient | Edinburgh, United Kingdom | Problems found, fixed voluntarilyNov 2021 | |
| Advagen Pharma Ltd.2 mg, 4 mg, 8 mg, 12 mg · NDC 72888-510, 72888-182, 72888-509 +1 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 |
| Aveva Drug Delivery Systems Inc.5 ug per 1 h, 7.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 3215-1523, 3215-1524, 3215-1525 +2 | Aveva Drug Delivery Systems Inc.Makes it | Miramar, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Camber Pharmaceuticals Inc.2 mg, 8 mg · NDC 31722-870, 31722-871 | 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, 8 mg · NDC 62756-459, 62756-460 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Gland Pharma Limited0.324 mg per 1 mL · NDC 68083-696 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| H.J. Harkins Co., Inc.8 mg · NDC 76519-1170 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Hikma Pharmaceuticals USA Inc.2 mg, 8 mg · NDC 0054-0176, 0054-0177 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Ingenus Pharmaceuticals, LLC5 ug per 1 h, 7.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 50742-374, 50742-375, 50742-376 +2 | Aveva Drug Delivery Systems Inc.Makes it and tests it | Miramar, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Knoa Pharma LLC Butrans5 ug per 1 h, 7.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 59011-751, 59011-758, 59011-752 +2 | LTS Lohmann Therapy Systems Corp.Makes it | West Caldwell, NJ, United States | No problems foundFeb 2024 |
| Somerset Therapeutics, LLC0.324 mg per 1 mL · NDC 70069-027 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Actavis Pharma, Inc.2 mg, 8 mg · NDC 0228-3156, 0228-3153 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Alvogen Inc.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 47781-407, 47781-419, 47781-408 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals5 ug per 1 h, 7.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 69238-1203, 69238-1204, 69238-1205 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| BioDelivery Sciences International Inc Belbuca75 ug, 150 ug, 300 ug, 450 ug, 600 ug, 750 ug · NDC 59385-022, 59385-023, 59385-024 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Braeburn Inc. Brixadi8 mg per 0.16 mL, 16 mg per 0.32 mL, 24 mg per 0.48 mL, 32 mg per 0.64 mL, 64 mg per 0.18 mL, 96 mg per 0.27 mL · NDC 58284-228, 58284-216, 58284-224 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.0.324 mg per 1 mL · NDC 42023-179 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.0.324 mg per 1 mL · NDC 0143-9246 | The label doesn't name the factory. Plants this company names for other drugs | ||
| LTS Therapy Systems, LLC20 ug/h · NDC 58064-408 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.2 mg, 8 mg · NDC 0121-1019, 0121-2038 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SpecGx LLC2 mg, 8 mg · NDC 0406-7012, 0406-7018 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.5 ug per 1 h, 7.5 ug per 1 h, 10 ug per 1 h, 15 ug per 1 h, 20 ug per 1 h · NDC 0093-3657, 0093-3658, 0093-3659 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Buprenorphine 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.
- A-S Medication Solutions:
50090-7559,50090-5805 - Aidarex Pharmaceuticals LLC:
53217-246 - American Health Packaging:
60687-481,60687-492 - AvPAK:
50268-128,50268-129 - Bryant Ranch Prepack:
71335-0950,72162-1344,63629-9475,63629-4092+4 - Clinical Solutions Wholesale:
58118-3156,58118-0501,58118-0176,58118-4459+3 - Coupler Enterprises Inc.:
67046-994,67046-990,67046-996,67046-995+2 - Direct Rx:
72189-579,72189-580,72189-582 - Major Pharmaceuticals:
0904-7154,0904-7155 - NuCare Pharmaceuticals.Inc.:
68071-2592,68071-2915 - Rebel Distributors Corp..:
21695-515 - RedPharm Drug. Inc.:
67296-1506,67296-2123,67296-1862,67296-2173 - Remedyrepack Inc.:
70518-2226,70518-1557,70518-4570,70518-2014+1 - TYA Pharmaceuticals:
64725-1924,64725-0930 - Unit Dose Solutions, Inc.:
87441-011,87441-082
Recalls
- Sep 8, 2026 · Class II · Par Health USA, LLC
Crystallization - Aug 19, 2026 · Class III · American Health Packaging
Labeling: Label Mix-up - Jun 12, 2026 · Class II · Par Health USA, LLC
Crystallization; identified as Buprenorphine free base - Mar 13, 2026 · Class II · ENDO USA, Inc.
Crystallization; identified as Buprenorphine free base - May 20, 2024 · Class II · Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals. - May 3, 2023 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations - Nov 9, 2021 · Class II · PAR Sterile Products LLC
Crystallization; identified as Buprenorphine free base - Mar 15, 2021 · Class II · Cardinal Health Inc. · 2 recall notices
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Sep 4, 2020 · Class II · Teva Pharmaceuticals USA
Failed Stability Specifications: Below specification result for buprenorphine release rate. - Aug 14, 2020 · Class II · Hikma Pharmaceuticals USA Inc.
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. - Apr 28, 2017 · Class II · PAR Sterile Products LLC
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. - Sep 9, 2014 · Class II · Hospira Inc.
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.