Topoisomerase Inhibitor

Where is Topotecan made?

8 companies sell it under their own name. Their labels name 7 factories in India, the United States, Taiwan and Australia.

India 3United States 2Taiwan 1Australia 1
India: 3United States: 2Taiwan: 1Australia: 1

Companies and their factories

Company on the labelFactoryWhereLast FDA inspection
Fresenius Kabi, LLC4 mg per 4 mL · NDC 63323-762 Fresenius Kabi USA, LLCMakes it and tests it Grand Island, NY, United StatesProblems found, fixed voluntarilyOct 2023
Fresenius Kabi USA, LLCMakes it and tests it Melrose Park, IL, United StatesProblems found, fixed voluntarilyAug 2023
ScinoPharm Taiwan, Ltd.Makes the active ingredient Tainan, TaiwanSerious problems, FDA actionJun 2026
Hospira, Inc.1 mg per 1 mL · NDC 0409-0302 Hospira Australia Pty LtdMakes it, tests it, packages it and labels it Mulgrave, AustraliaProblems found, fixed voluntarilySep 2022
Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it Ahmedabad, IndiaProblems found, fixed voluntarilyJun 2023
Accord Healthcare Inc.1 mg per 1 mL, 4 mg per 4 mL · NDC 16729-243, 16729-151 Intas Pharmaceuticals LimitedMakes it and tests it Ahmedabad, IndiaNo problems foundJul 2024
Bedford Laboratories4 mg per 4 mL · NDC 55390-370 Cipla LimitedMakes it and tests it Salcette, IndiaProblems found, fixed voluntarilyJun 2024
Actavis Pharma, Inc.4 mg per 4 mL · NDC 45963-615The label doesn't name the factory. Plants this company names for other drugs
Meitheal Pharmaceuticals Inc.4 mg per 15 mL · NDC 71288-127The label doesn't name the factory. Plants this company names for other drugs
Novartis Pharmaceuticals Corporation Hycamtin4 mg per 4 mL · NDC 0078-0674The label doesn't name the factory. Plants this company names for other drugs
Sandoz Inc. Hycamtin.25 mg, 1 mg · NDC 66758-101, 66758-102The label doesn't name the factory. Plants this company names for other drugs