4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Where is Nitisinone made?
5 companies sell it under their own name and 1 repackager rebottle it. Their labels name 4 factories in the United Kingdom, Switzerland and Sweden.
United Kingdom 2Switzerland 1Sweden 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cycle Pharmaceuticals Ltd. Nityr, Harliku2 mg, 5 mg, 10 mg · NDC 70709-000, 70709-112, 70709-002 +1 | Penn Pharmaceutical Services LimitedMakes it, tests it and packages it | Tredegar, United Kingdom | Problems found, fixed voluntarilyApr 2022 |
| Pharmaron Manufacturing Services (UK) LimitedMakes the active ingredient | Cramlington, United Kingdom | Problems found, fixed voluntarilyFeb 2022 | |
| Rivopharm SaMakes it, tests it and packages it | Manno, Switzerland | No problems foundJun 2023 | |
| Swedish Orphan Biovitrum Ab (publ) Orfadin2 mg, 4 mg per 1 mL, 5 mg, 10 mg, 20 mg · NDC 66658-110, 66658-102, 66658-120 +2 | Apotek Produktion & Laboratorier ABMakes it | Kungens Kurva, Sweden | No problems foundApr 2022 |
| Analog Pharma2 mg, 5 mg, 10 mg, 20 mg · NDC 70505-210, 70505-202, 70505-220 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Eton Pharmaceuticals, Inc.2 mg, 5 mg, 10 mg, 20 mg · NDC 71863-121, 71863-119, 71863-122 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC2 mg, 5 mg, 10 mg · NDC 0254-3022, 0254-3020, 0254-3021 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Nitisinone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
63629-2233,63629-2234,63629-2235