Sigmapharm files an Abbreviated New Drug Application (ANDA No. 211084) which includes a paragraph-IV certification (our 9th Paragraph-IV filing).
Sigmapharm files a Drug Master File for Amorphous Vortioxetine Hydrobromide (Type II DMF No. 031898).
Sigmapharm successfully completes an FDA inspection focused on its current GMP status.
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.