Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Par Formulations Private Limited | Chennai, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 10, 2026 · 7 inspections |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA207200
- On the market since
- Oct 1, 2020
- Package NDCs
49884-720-08- Official label
- DailyMed (National Library of Medicine), updated Apr 17, 2026
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