Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amryt GmbH | Niefern-Öschelbronn, Germany | Makes the active ingredient, tests it, packages it and labels it | Problems found, fixed voluntarilyDec 6, 2022 · 1 inspection |
| Lichtenheldt GmbH Pharmazeutische Fabrik | Wahlstedt, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 17, 2022 · 1 inspection |
| BioChem Labor für biologische und chemische Analytik GmbH | Karlsruhe, Germany | Tests it | No problems foundMar 23, 2022 · 4 inspections |
| Cit SRL | Burago Di Molgora, Italy | Packages it | Not inspected on record |
| Eurofins BioPharma Product Testing Hamburg GmbH | Hamburg, Germany | Tests it | Problems found, fixed voluntarilyOct 19, 2022 · 3 inspections |
| Lichtenheldt GmbH Pharmazeutische Fabrik | Wahlstedt, Germany | Tests it | Problems found, fixed voluntarilyFeb 17, 2022 · 1 inspection |
| NUVISAN GmbH | Neu-Ulm, Germany | Tests it | Problems found, fixed voluntarilyOct 17, 2024 · 5 inspections |
| Pharma Packaging Solutions, LLC | Clinton, TN, United States | Packages it | No problems foundJun 28, 2023 · 4 inspections |
| Synergy Health Radeberg Gmbh | Radeberg, Germany | Sterilizes it | Not inspected on record |
Product details
- Generic drug
- Birch Triterpenes: every company that makes it
- Form
- gel, topical
- Strength
- 100 mg per 1 g
- Approval
- NDA NDA215064
- On the market since
- Feb 22, 2024
- Package NDCs
10122-310-0110122-310-02- Official label
- DailyMed (National Library of Medicine), updated Jul 24, 2026
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