Wavelength Enterprises is an API manufacturer based in Israel. It holds 136 active US drug master files across a filed portfolio of 29 molecules. Its GMP standing is certified by EMA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 14 December 2022 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Israel, Israel | 3002806718 |
| Beer Sheva, Israel | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Cetirizine | US FDA | 8 |
| Cisatracurium | US FDA | 8 |
| Granisetron | US FDA | 8 |
| Mometasone Furoate | US FDA | 8 |
| Pramipexole | US FDA | 8 |
| Cilostazol | US FDA | 4 |
| Clascoterone | US FDA | 4 |
| Donepezil | US FDA | 4 |
| Efinaconazole | US FDA | 4 |
| Fluticasone Furoate | US FDA | 4 |
| Fluticasone Propionate | US FDA | 4 |
| Fulvestrant | US FDA | 4 |
| Halobetasol Propionate | US FDA | 4 |
| Ibrutinib | US FDA | 4 |
| Imiquimod | US FDA | 4 |
| Midazolam | US FDA | 4 |
| Modafinil | US FDA | 4 |
| Omeprazole | US FDA | 4 |
| Palonosetron | US FDA | 4 |
| Permethrin | US FDA | 4 |
| Pralidoxime | US FDA | 4 |
| Rocuronium | US FDA | 4 |
| Rotigotine | US FDA | 4 |
| Sitagliptin | US FDA | 4 |
| Sugammadex | US FDA | 4 |
| Tavaborole | US FDA | 4 |
| Temozolomide | US FDA | 4 |
| Tiotropium | US FDA | 4 |
| Tramadol | US FDA | 4 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
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