Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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    Analog Pharma and Dipharma Announce US FDA Approval of Abbreviated New Drug Application (ANDA) of 20 mg Generic Nitisinone Capsules (temperature stable)

    Details:

    Orfadin (nitisinone) is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1.


    Lead Product(s): Nitisinone

    Therapeutic Area: Genetic Disease Product Name: Orfadin-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Dipharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 31, 2023

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