• December 2020
    • Sigmapharm receives FDA approval for generic Asenapine Sublingual Tablets, 5 mg and 10 mg, based on its ANDA No. 206107 containing a Paragraph IV certification.

    • Sigmapharm launches its generic Asenapine Sublingual Tablets, 5 mg and 10 mg.

  • 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.