Nucleoside Metabolic Inhibitor
Where is Gemcitabine made?
13 companies sell it under their own name. Their labels name 13 factories in India, the United States, Switzerland, China, Italy and Germany.
India 6United States 3Switzerland 1China 1Italy 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Inlexzo225 mg · NDC 57894-225 | BSP Pharmaceuticals SpAMakes it and tests it | Latina Scalo (LT), Italy | Problems found, fixed voluntarilyNov 2021 |
| Catalent CTS, LLCMakes it, tests it and packages it | Kansas City, MO, United States | No problems foundMar 2022 | |
| Corden Pharma GmbHMakes it, tests it and packages it | Plankstadt, Germany | Problems found, fixed voluntarilyOct 2025 | |
| NACS, Inc.Makes it | Ham Lake, MN, United States | Not inspected on record | |
| Shilpa Pharma Lifesciences LimitedMakes the active ingredient and tests it | Raichur, India | Problems found, fixed voluntarilyMar 2025 | |
| Dr.Reddy's Laboratories Ltd.1 g per 25 mL, 200 mg per 5 mL · NDC 55111-687, 55111-686 | Cipla LimitedMakes it, tests it and packages it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Dr.reddy's Laboratories LimitedMakes it, tests it and packages it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 | |
| Kindos Pharmaceuticals Co., Ltd.Makes it, tests it and packages it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 | |
| Avyxa Pharma, LLC Avgemsi38 mg per 1 mL · NDC 83831-122, 83831-123, 83831-124 | Avyxa GmbHMakes it, tests it, packages it, labels it and sterilizes it | Barbengo, Switzerland | Problems found, fixed voluntarilyOct 2024 |
| Bedford Laboratories40 mg per 1 mL · NDC 55390-391 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Fresenius Kabi, LLC1 g per 25 mL, 2 g per 50 mL, 200 mg per 5 mL · NDC 63323-125, 63323-126, 63323-102 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited1 g per 25 mL, 200 mg per 5 mL · NDC 68083-149, 68083-148 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Hospira, Inc.38 mg per 1 mL · NDC 0409-0187, 0409-0185, 0409-0186 +3 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Teyro Labs Private Limited1 g per 25 mL, 200 mg per 5 mL · NDC 82511-009, 82511-008 | Teyro Labs Private LimitedMakes it, tests it and packages it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| Hikma Pharmaceuticals USA Inc.38 mg per 1 mL · NDC 0143-9340, 0143-9341, 0143-9342 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.1 g, 38 mg per 1 mL, 200 mg · NDC 71288-114, 71288-113, 71288-117 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC1 g per 26.3 mL, 2 g per 52.6 mL, 200 mg per 5.26 mL · NDC 67457-617, 67457-618, 67457-616 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.1 g, 200 mg · NDC 16714-930, 16714-909 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1 g per 25 mL, 38 mg per 1 mL, 200 mg per 5 mL · NDC 25021-235, 25021-234, 25021-239 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jun 10, 2026 · Class II · McKesson
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.