Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Annora Pharma Private Limited | Sangareddy, India | Makes it | Problems found, fixed voluntarilyMar 28, 2025 · 4 inspections |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA215534
- On the market since
- Aug 23, 2022
- Package NDCs
31722-045-12- Official label
- DailyMed (National Library of Medicine), updated Feb 24, 2026
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