• November 2014

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

  • June 2014
    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207744).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207745) which includes a Paragraph-IV certification (our 4th Paragraph-IV filing).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207746) which includes a Paragraph-IV certification (our 3rd Paragraph-IV filing).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207528).

    • Sigmapharm files a Drug Master File for Amorphous Dofetilide (DMF No. 028301).

  • March 2014

    Sigmapharm completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 205569.

  • September 2013

    Sigmapharm launches, exclusively under its own label, its 10th generic product, Adefovir Dipivoxil Tablets, 10 mg, which is the first-and-only approved generic equivalent to Gilead’s HEPSERA® Tablets.

  • August 2013
    • Sigmapharm receives FDA approval for generic Adefovir Dipivoxil Tablets, 10 mg, based on its ANDA No. 202051 containing a First-to-File Paragraph-IV certification.

    • Sigmapharm successfully completes an FDA inspection focused on the company’s reporting of its Post-marketing Adverse Drug Experience.

    • Sigmapharm files a Drug Master File for Amorphous Asenapine Maleate (DMF No. 027300). 

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 206107) which includes a Paragraph-IV certification (our 2nd Paragraph-IV filing).

  • April 2013

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).

  • March 2013
    • Sigmapharm launches, exclusively under its own label, its 9th generic product, Sodium Phenylbutyrate Powder in 250-g-fill Bottles, which is the first-and-only approved generic equivalent to BUPHENYL® Powder.

    • Sigmapharm receives FDA approval for generic Sodium Phenylbutyrate Powder in 250-g-fill Bottles, based on its ANDA No. 202819.

  • December 2012

    Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 8th generic product, Griseofulvin Tablets, USP (microsize) 500 mg, which is the first-and-only approved generic equivalent to GRIFULVIN-V® Tablets.