Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA216797
- On the market since
- Jun 9, 2025
- Package NDCs
59651-574-0859651-574-2459651-574-30- Official label
- DailyMed (National Library of Medicine), updated Jun 10, 2025
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