Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| BSP Pharmaceuticals SpA | Latina Scalo (LT), Italy | Makes it and tests it | Problems found, fixed voluntarilyNov 12, 2021 · 6 inspections |
| Catalent CTS, LLC | Kansas City, MO, United States | Makes it, tests it and packages it | No problems foundMar 4, 2022 · 8 inspections |
| Corden Pharma GmbH | Plankstadt, Germany | Makes it, tests it and packages it | Problems found, fixed voluntarilyOct 15, 2025 · 5 inspections |
| NACS, Inc. | Ham Lake, MN, United States | Makes it | Not inspected on record |
| Shilpa Pharma Lifesciences Limited | Raichur, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 7, 2025 · 1 inspection |
| Alcami Carolinas Corporation | St. Louis, MO, United States | Tests it | Problems found, fixed voluntarilyOct 4, 2024 · 7 inspections |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it | No problems foundMay 8, 2025 · 6 inspections |
| Eurofins Biolab Srl | Vimodrone, Italy | Tests it | Problems found, fixed voluntarilySep 13, 2024 · 5 inspections |
| Isomedix Operations Inc. | Minneapolis, MN, United States | Sterilizes it | Problems found, fixed voluntarilySep 15, 2023 · 1 inspection |
| Janssen Pharmaceutica NV | Beerse, Belgium | Tests it and packages it | Problems found, fixed voluntarilySep 5, 2025 · 8 inspections |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
| Labor LS SE & Co. KG | Bad Bocklet, Germany | Tests it | Problems found, fixed voluntarilyDec 14, 2022 · 6 inspections, 1 with FDA action |
| SGS India Private Limited | Navi Mumbai, India | Tests it | No problems foundJul 5, 2024 · 2 inspections |
| Shilpa Pharma Lifesciences Limited | Raichur, India | Tests it | No problems foundMar 14, 2025 · 6 inspections, 1 with FDA action |
| Sterigenics U.S., LLC | Charlotte, NC, United States | Sterilizes it | No problems foundDec 3, 2025 · 4 inspections |
| Sterigenics U.S., LLC | Gurnee, IL, United States | Sterilizes it | No problems foundDec 6, 2013 · 3 inspections |
| Steris Laboratories | Brooklyn Park, MN, United States | Sterilizes it | Not inspected on record |
Product details
- Generic drug
- Gemcitabine: every company that makes it
- Form
- system, intravesical
- Strength
- 225 mg
- Approval
- NDA NDA219683
- On the market since
- Sep 14, 2025
- Package NDCs
57894-225-0157894-225-99- Official label
- DailyMed (National Library of Medicine), updated Oct 26, 2026
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