Alkylating Drug
Where is Busulfan made?
9 companies sell it under their own name. Their labels name 5 factories in India, China and Canada.
India 3China 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.6 mg per 1 mL · NDC 16729-351 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| AuroMedics Pharma LLC6 mg per 1 mL · NDC 55150-395 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Hospira, Inc.6 mg per 1 mL · NDC 0409-1112 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Visakhapatnam, India | No problems foundJul 2023 |
| Meitheal Pharmaceuticals Inc.6 mg per 1 mL · NDC 71288-158, 71288-116 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Pharmascience Inc.6 mg per 1 mL · NDC 51817-170 | Pharmascience Inc.Makes it | Candiac, Canada | Problems found, fixed voluntarilyFeb 2024 |
| Amneal Pharmaceuticals LLC6 mg per 1 mL · NDC 70121-1244 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Otsuka America Pharmaceutical, Inc. Busulfex6 mg per 1 mL · NDC 59148-070 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals6 mg per 1 mL · NDC 25021-241 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Waylis Therapeutics LLC Myleran2 mg · NDC 80725-620 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 4, 2026 · Class III · Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.