• June 2010
    • Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 2nd generic product, Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, which is the second approved generic equivalent to VIVACTIL® Tablets.

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202051), which contains a Paragraph-IV certification.  This is our 1st Paragraph-IV filing.

    • Sigmapharm files a Drug Master File for Amorphous Adefovir Dipivoxil (DMF No. 023844).  This is our 1st DMF submission.

  • May 2010

    Sigmapharm receives FDA approval for generic Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, based on its ANDA No. 090462.

  • March 2010

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 201566).

  • September 2009
    • Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 091004.

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 200295).

  • July 2009

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 091619).

  • April 2009

    Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 1st generic product, Amiloride Hydrochloride Tablets, USP 5 mg, which is the second approved generic equivalent to MIDAMOR® Tablets.

  • January 2009

    Sigmapharm receives FDA approval for generic Amiloride Hydrochloride Tablets, USP 5 mg, based on its ANDA No. 079133.  This is our 1st ANDA approval.

  • November 2008

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 091004).

  • March 2008

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 090462).

  • January 2008

    Sigmapharm completes its 1st FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 079133.