Rifamycin Antibacterial
Where is Rifampin made?
11 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 8 factories in the United States, Italy, Portugal and India.
United States 3Italy 3Portugal 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Rifadin IV, Rifadin IV NOVAPLUS600 mg per 10 mL · NDC 0068-0597, 0068-0599, 0068-0660 | Euroapi Italy SRLMakes the active ingredient and tests it | Brindisi, Italy | Serious problems, FDA actionJul 2026 |
| Sanofi S.r.l.Makes it, tests it, packages it and labels it | Anagni, Italy | Problems found, fixed voluntarilyOct 2024 | |
| ANI Pharmaceuticals, Inc.150 mg, 300 mg · NDC 70954-892, 70954-893 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Akorn600 mg per 10 mL · NDC 17478-151 | Patheon Italia S.p.AMakes it, tests it and packages it | Ferentino, Italy | Problems found, fixed voluntarilyFeb 2022 |
| Epic Pharma, LLC150 mg, 300 mg · NDC 42806-801, 42806-799 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Fresenius Kabi, LLC600 mg · NDC 63323-351 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hikma Pharmaceuticals USA Inc.600 mg · NDC 0143-9230 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Lupin Pharmaceuticals, Inc.150 mg, 300 mg · NDC 68180-658, 68180-659 | Lupin LimitedMakes it and packages it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyMar 2024 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals150 mg, 300 mg · NDC 24658-801, 24658-802 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Chartwell RX, LLC.150 mg, 300 mg · NDC 62135-315, 62135-316 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Department of State Health Services, Pharmacy Branch300 mg · NDC 55695-034 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC600 mg per 10 mL · NDC 67457-445 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Rifampin 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:
50090-0964,50090-5709 - American Health Packaging:
60687-575,60687-586 - Bryant Ranch Prepack:
71335-2613 - Carilion Materials Management:
68151-0985 - Central Texas Community Health Centers:
76413-136,76413-137 - Coupler LLC:
67046-1605 - Department of State Health Services, Pharmacy Branch:
55695-036 - H.J. Harkins Co., Inc.:
52959-653 - Major Pharmaceuticals:
0904-7315 - Physicians Total Care, Inc.:
54868-5472,54868-4683 - RPK Pharmaceuticals, Inc.:
53002-6430,53002-6431 - Rebel Distributors Corp..:
21695-527,42254-039 - State of Florida DOH Central Pharmacy:
53808-0559
Recalls
- Jan 5, 2024 · Class II · Lupin Pharmaceuticals Inc. · 2 recall notices
Subpotent Drug and Failed Impurities/Degradation Specifications - Dec 20, 2022 · Class II · Amerisource Health Services LLC
Failed Impurities/Degradations Specifications - Dec 12, 2022 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. - Jul 28, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. - Apr 7, 2022 · Class II · Mylan Pharmaceuticals Inc
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. - Oct 7, 2019 · Class II · Mylan Laboratories Limited (Sterile Products Division)
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. - Aug 20, 2015 · Class III · Akorn, Inc.
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. - Jun 4, 2015 · Class II · Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation - Aug 5, 2014 · Class III · Akorn, Inc.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.