Alkylating Drug
Where is Mitomycin made?
12 companies sell it under their own name and 1 repackager rebottle it. Their labels name 7 factories in India, the United States and China.
India 5United States 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord BioPharma Inc.5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 69448-002, 69448-003, 69448-001 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Accord Healthcare Inc.5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 16729-108, 16729-116, 16729-115 | Intas Pharmaceuticals LimitedMakes it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Archis Pharma LLC5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 72819-153, 72819-154, 72819-152 | Mylan Laboratories LimitedMakes it | Bangalore, India | Problems found, fixed voluntarilyMay 2022 |
| RK Pharma Inc.Makes it | Pearl River, NY, United States | Problems found, fixed voluntarilyMay 2024 | |
| AuroMedics Pharma LLC5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 55150-451, 55150-452, 55150-450 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| BluePoint Laboratories.5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 68001-616, 68001-617, 68001-615 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Fresenius Kabi USA, LLC5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 65219-566, 65219-568, 65219-564 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Gland Pharma Limited5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 68083-484, 68083-502, 68083-483 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Meitheal Pharmaceuticals Inc.5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 71288-138, 71288-139, 71288-137 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc.20 mg, 20 mg per 40 mL, 40 mg, 40 mg per 80 mL · NDC 0143-9135, 0143-9279, 0143-9136 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mobius Therapeutics LLC Mitosol0.2 mg per 1 mL · NDC 49771-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 10 mL, 20 mg per 40 mL, 40 mg per 80 mL · NDC 25021-251, 25021-252, 25021-250 | The label doesn't name the factory. Plants this company names for other drugs | ||
| UroGen Pharma, Inc. Zusduri, Jelmyto40 mg · NDC 72493-106, 72493-103 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Mitomycin 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.
- Bryant Ranch Prepack:
72162-2464,71335-2927
Recalls
- Jan 3, 2013 · Class I · Mobius Therapeutics LLC
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.