Folate Analog Metabolic Inhibitor
Where is Pralatrexate made?
3 companies sell it under their own name. Their labels name 2 factories in Germany and India.
Germany 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Acrotech Biopharma Inc Folotyn20 mg per 1 mL, 40 mg per 2 mL · NDC 72893-003, 72893-005 | Simtra Deutschland GmbHMakes it | Halle/Westfalen, Germany | Serious problems, FDA actionSep 2025 |
| Dr. Reddy's Laboratories Inc.20 mg per 1 mL, 40 mg per 2 mL · NDC 43598-342, 43598-343 | Dr.reddy's Laboratories LimitedMakes it, tests it and packages it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Fresenius Kabi USA, LLC20 mg per 1 mL, 40 mg per 2 mL · NDC 65219-550, 65219-552 | Simtra Deutschland GmbHMakes it | Halle/Westfalen, Germany | Serious problems, FDA actionSep 2025 |