API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
Details:
As per agreement, Aptar Pharma will evaluate the commercial applications for the Orbital device & further develop the prototype device to meet unmet market needs. Pharmaxis retains the rights to devices containing Orbital intellectual property used to deliver inhaled mannitol.
Lead Product(s): Mannitol API
Therapeutic Area: Genetic Disease Product Name: Bronchitol
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aptar Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 17, 2021
Details:
In the multicenter, double-blind, randomized, parallel-group, controlled study of 423 adults with CF, subjects received either mannitol 400mg or mannitol 50mg (control), twice-daily via dry powder inhaler for 26 weeks.
Lead Product(s): Mannitol API
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Bronchitol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2021