Aminoglycoside Antibacterial
Where is Tobramycin made?
36 companies sell it under their own name and 19 repackagers rebottle it. Their labels name 18 factories in India, the United States, China and Germany.
India 8United States 7China 2Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Northstar Rx LLC.1.2 g per 30 mL, 300 mg per 4 mL, 300 mg per 5 mL · NDC 72603-160, 72603-630, 16714-119 +1 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 | |
| Rommelag CDMO GmbHMakes it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 | |
| Alembic Pharmaceuticals Inc.3 mg per 1 mL · NDC 62332-518 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Amneal Pharmaceuticals300 mg per 5 mL · NDC 65162-914 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 |
| Catalent Pharma Solutions, LLCMakes it and tests it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 | |
| Fresenius Kabi, LLC10 mg per 1 mL, 40 mg per 1 mL, 1200 mg per 30 mL · NDC 63323-305, 63323-303, 63323-306 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Genericus, Inc.300 mg per 5 mL · NDC 70644-899 | Chongqing Daxin Pharmaceutical Co., Ltd.Makes the active ingredient | Chongqing, China | Problems found, fixed voluntarilyJun 2024 |
| Woodstock Sterile Solutions, Inc.Makes it, tests it, packages it and labels it | Woodstock, IL, United States | No problems foundOct 2022 | |
| Pari Respiratory Equipment, Inc. Kitabis Pak300 mg per 5 mL · NDC 24492-850 | Chongqing Daxin Pharmaceutical Co., Ltd.Makes the active ingredient | Chongqing, China | Problems found, fixed voluntarilyJun 2024 |
| Woodstock Sterile Solutions, Inc.Makes it | Woodstock, IL, United States | No problems foundOct 2022 | |
| Akorn3 mg per 1 mL, 300 mg per 5 mL · NDC 17478-290, 17478-340 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Limited3 mg per 1 mL · NDC 46708-518 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Ascend Laboratories, LLC300 mg per 5 mL · NDC 67877-678 | Rommelag CDMO GmbHMakes it and packages it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 |
| AuroMedics Pharma LLC1.2 g per 30 mL · NDC 55150-470 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Aurobindo Pharma Limited300 mg per 5 mL · NDC 59651-129 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Bausch & Lomb Incorporated3 mg per 1 mL · NDC 24208-290 | Bausch & Lomb IncorporatedMakes it, packages it and labels it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Baxter Healthcare Corporation40 mg per 1 mL · NDC 36000-242, 36000-244 | Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 |
| Belcher Pharmaceuticals,LLC3 mg per 1 mL · NDC 62250-110 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.300 mg per 5 mL · NDC 47335-171 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Dr. Reddy's Laboratories Inc.300 mg per 5 mL · NDC 43598-605 | Rommelag CDMO GmbHMakes it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 |
| Gland Pharma Limited1.2 g per 30 mL, 3 mg per 1 mL, 10 mg per 1 mL, 40 mg per 1 mL · NDC 68083-312, 68083-253, 68083-374 +2 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hospira, Inc.40 mg per 1 mL · NDC 0409-3578 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Jvet Pharmaceuticals LLC3 mg per 1 mL · NDC 86211-110 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Lifestar Pharma LLC.300 mg per 4 mL, 300 mg per 5 mL · NDC 70756-617, 70756-604 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| MWI/VetOne3 mg per 1 mL · NDC 13985-604 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Micro Labs Limited300 mg per 5 mL · NDC 42571-408 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Slate Run Pharmaceuticals, LLC.1200 mg per 30 mL · NDC 70436-110 | Hainan Poly Pharm. Co., Ltd.Makes it and makes the active ingredient | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Somerset Therapeutics, LLC3 mg per 1 mL · NDC 70069-131 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Xiromed, LLC.1.2 g per 30 mL · NDC 70700-173 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Chiesi USA, Inc. Bethkis300 mg per 4 mL · NDC 10122-820 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.1.2 g per 30 mL · NDC 72266-163 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.300 mg per 5 mL · NDC 68180-962 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC40 mg per 1 mL · NDC 67457-473, 67457-428 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Tobrex3 mg per 1 g · NDC 0078-0813 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories300 mg per 4 mL · NDC 66993-195 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ritedose Pharmaceuticals, LLC300 mg per 5 mL · NDC 76204-029 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.3 mg per 1 mL · NDC 61314-643 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.300 mg per 5 mL · NDC 0093-4085 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC TOBI Podhaler, Tobi28 mg, 300 mg per 5 mL · NDC 49502-401, 49502-345 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.1.2 g per 30 mL · NDC 39822-0412 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tobramycin 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:
50090-3569,50090-2127,50090-4190 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0341 - Aidarex Pharmaceuticals LLC:
33261-519 - American Health Packaging:
60687-731 - Asclemed USA, Inc.:
76420-092,76420-791 - Blenheim Pharmacal, Inc.:
10544-883 - Direct Rx:
61919-224,61919-598,61919-642 - H.J. Harkins Co., Inc.:
52959-108 - Medsource Pharmaceuticals:
45865-427,45865-119 - NuCare Pharmaceuticals.Inc.:
66267-936,68071-2272 - Preferred Pharmaceuticals, Inc..:
68788-4149,68788-7252 - Proficient Rx LP:
63187-973,63187-902,71205-101,63187-024 - RPK Pharmaceuticals, Inc.:
53002-9232,53002-9230 - Rebel Distributors Corp..:
21695-458,21695-204,42254-187 - RedPharm Drug. Inc.:
67296-0391,67296-1639 - Remedyrepack Inc.:
70518-1370 - Sportpharm LLC:
85766-025,85766-189 - St. Mary's Medical Park Pharmacy:
60760-583 - Stat Rx USA:
16590-225,16590-224
Recalls
- Feb 22, 2024 · Class II · Eugia US LLC
Failed Stability Specification: Water determination was found not complying with specification. - Jul 27, 2023 · Class III · Alembic Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications - Oct 13, 2022 · Class II · Akorn, Inc. · 2 recall notices
CGMP Deviations: - Jun 18, 2012 · Class III · Stat Rx USA
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.