• November 2010

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202545).

  • October 2010

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202482).

  • September 2010

    Gilead Sciences, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Adefovir Dipivoxil Tablets proposed as the generic equivalent of Gilead’s HEPSERA® Tablets.  

  • July 2010
    • Sigmapharm launches its 3rd generic product, Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), for commercial marketing through Rising Pharmaceuticals, Inc.

    • Sigmapharm receives FDA approval for generic Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), based on its ANDA No. 091004.

  • 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.