Phenylalanine Hydroxylase Activator
Where is Sapropterin made?
10 companies sell it under their own name. Their labels name 7 factories in India and the United States.
India 6United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited100 mg · NDC 59651-574 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Camber Pharmaceuticals Inc.100 mg, 500 mg · NDC 31722-045, 31722-047, 31722-048 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Dr. Reddy's Laboratories Inc.100 mg, 500 mg · NDC 43598-096, 43598-097, 43598-162 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| ENDO USA, Inc.100 mg, 500 mg · NDC 49884-720, 49884-948, 49884-873 | Par Formulations Private LimitedMakes it, tests it and packages it | Chennai, India | Problems found, fixed voluntarilyJun 2026 |
| Hikma Pharmaceuticals USA Inc.100 mg · NDC 0054-0906 | Zenara Pharma Private LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyMay 2024 |
| Micro Labs Limited100 mg, 500 mg · NDC 42571-509, 42571-510 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.100 mg, 500 mg · NDC 72603-193, 72603-191, 72603-194 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| TruPharma LLC.100 mg, 500 mg · NDC 52817-850, 52817-851 | Mikart, LLCMakes it, packages it and labels it | Atlanta, GA, United States | No problems foundAug 2026 |
| Aucta Pharmaceuticals, Inc.100 mg, 500 mg · NDC 73289-0070, 73289-0071 | The label doesn't name the factory. Plants this company names for other drugs | ||
| BioMarin Pharmaceutical Inc. Kuvan100 mg, 500 mg · NDC 68135-300, 68135-301, 68135-482 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 22, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications - Apr 8, 2024 · Class I · Dr. Reddy's Laboratories, Inc.
Sub-potent Drug; powder discoloration associated with decreased potency
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.