Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| TOYO Pharmaceutical Co., Ltd. | Osaka, Japan | Makes it and tests it | Problems found, fixed voluntarilyJun 16, 2023 · 1 inspection |
| Sharp Clinical Services, LLC | Bethlehem, PA, United States | Tests it, packages it and labels it | No problems foundAug 29, 2024 · 6 inspections |
Product details
- Generic drug
- Sirolimus: every company that makes it
- Form
- gel, topical
- Strength
- 2 mg per 1 g
- Approval
- NDA NDA213478
- On the market since
- Mar 23, 2022
- Package NDCs
73683-101-10- Official label
- DailyMed (National Library of Medicine), updated Aug 22, 2025
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