• March 2020

    Sigmapharm relaunches its generic Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, exclusively under its own label.

  • December 2019

    Sigmapharm relaunches its generic Griseofulvin Tablets, USP (microsize) 500 mg, exclusively under its own label.

  • October 2019

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 213896) which is designated by the FDA as a Competitive Generics Therapy (CGT) product.

  • June 2019

    Sigmapharm launches its generic Ambrisentan Tablets, 5mg and 10mg.

  • May 2019

    Dr. Spireas, the Founder, Chairman and Chief Executive Officer of Sigmapharm Laboratories, received today (May 14, 2019) an Honorary Doctor of Science (D.Sc.) degree from Long Island University, Brooklyn, New York.

  • April 2019

    Sigmapharm receives FDA approval for generic Ambrisentan Tablets, 5 mg and 10 mg, based on its ANDA No. 208354 containing a Paragraph IV certification.

  • October 2018

    Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 211084.

  • July 2018
    • Sigmapharm receives FDA approval for generic Asenapine Sublingual Tablets, 5 mg and 10 mg, based on its ANDA No. 206107 containing a First-to-File Paragraph-IV certification.

    • Sigmapharm launches, exclusively under its own label, its 12th generic product, Dofetilide Capsules, 0.125 mg, 0.25 mg and 0.5 mg, which is the second approved generic equivalent to TIKOSYN® Capsules.

  • June 2018
    • Sigmapharm successfully completes an FDA inspection focused on the company’s reporting of its Post-marketing Adverse Drug Experience.

    • Sigmapharm relaunches its generic Flucytosine Capsules, USP 250 mg and 500 mg, exclusively under its own label.

  • May 2018
    • Sigmapharm receives FDA approval for generic Nitroglycerin Sublingual Tablets, USP 0.3 mg, 0.4 mg and 0.6 mg, based on its ANDA No. 207745 containing a First-to-File Paragraph-IV certification.

    • Takeda Pharmaceuticals USA, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Vortioxetine Hydrobromide Tablets proposed as the generic equivalent of Takeda’s TRINTELLIX® Tablets.

    • Sigmapharm launches, exclusively under its own label, its generic Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, packaged in 90-count bottles.