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Sapropterin dihydrochloride

Drug ingredient

CAS 69056-38-8

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

Molecular structure of 69056-38-8
2 HCl
US productionNot reported
Top sourceNo public record

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Where It Comes From

EPA and Census publish no US supply data for this chemical.

19 FDA-registered drug labelers
Aucta Pharmaceuticals, Inc.
Aurobindo Pharma Limited
BioMarin Pharmaceutical Inc.
Biophore India Pharmaceuticals Pvt. Ltd
Camber Pharmaceuticals, Inc.
Dipharma Francis S.r.l.
DOTTIKON EXCLUSIVE SYNTHESIS AG
Dr. Reddy's Laboratories Inc.
ENDO USA, Inc.
Hikma Pharmaceuticals USA Inc.
Honour Lab Limited
Maithri Drugs Private Limited
Micro Labs Limited
NorthStar RxLLC
Seven Star Pharmaceutical Co., Ltd.
Shiratori Pharmaceutical Co., Ltd.
Solara Active Pharma Sciences Limited
Teva Pharmaceutical Works Private Limited Company
TRUPHARMA, LLC

Why It Matters

Sectors
Health
Downstream Uses

Appears in 4 drug and cosmetic product listings (FDA).

  • •Sapropterin dihydrochloride
  • •Kuvan
  • •Zelvysia
  • •Javygtor
FDA Shortage Status
No FDA shortage records

Chemical Identity

CAS69056-38-8
PubChem CID135409471
DTXSIDDTXSID0040620
FormulaC9H17Cl2N5O3
Mol. Weight314.17 g/mol
SMILESCC(C(C1CNC2=C(N1)C(=O)NC(=N2)N)O)O.Cl.Cl

Data Sources

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Brief citations

Sapropterin dihydrochloride (CAS 69056-38-8) https://chemicalindependence.com/chemical/69056-38-8/ PubChem: 135409471. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/135409471 FDA National Drug Code directory: CAS 69056-38-8. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA National Drug Code directory: bulk match. Retrieved 2026-04-07. https://open.fda.gov/data/ndc/