• September 2017

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 211084) which includes a paragraph-IV certification (our 9th Paragraph-IV filing).

  • August 2017

    Sigmapharm files a Drug Master File for Amorphous Vortioxetine Hydrobromide (Type II DMF No. 031898). 

  • June 2017

    Sigmapharm successfully completes an FDA inspection focused on its current GMP status.

  • April 2017

    Bristol Myers Squibb Company and Pfizer, Inc., sue Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Apixaban Tablets proposed as the generic equivalent of BMS-Pfizer’s ELIQUIS® Tablets.