Heraeus Precious Metals GmbH is a contract manufacturer based in Germany. It holds 8 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 5 August 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hanau, Germany | Not on file |
| Germany, Germany | 3002808476 |
| Molecule | Regulators | Docs |
|---|---|---|
| Oxaliplatin | SFDA (Saudi Arabia), US FDA | 3 |
| Aminolevulinic Acid | US FDA | 1 |
| Bendamustine | US FDA | 1 |
| Carboplatin | US FDA | 1 |
| Cisplatin | US FDA | 1 |
| Dacarbazine | US FDA | 1 |
| Thiotepa | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ZLG (DE) | None | 4 |
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