• December 2016

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 210053) which includes a Paragraph-IV certification (our 8th Paragraph-IV filing).

  • August 2016
    • Sigmapharm receives FDA approval for generic Potassium Chloride Extended-Release Tablets, USP 8 mEq (600 mg) and 10 mEq (750 mg), based on its ANDA No. 207528.

    • Sigmapharm files a Drug Master File for Amorphous Apixaban (Type II DMF No. 030774).

  • January 2016

    Sigmapharm successfully completes an FDA inspection focused on a Pre-Approval-Inspection related to its ANDA No. 207528.