API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFDA).
Lead Product(s): Sapropterin Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
Details:
The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.
Lead Product(s): Sapropterin Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2020