Sigmapharm Laboratories, LLC, a privately held specialty pharmaceutical company, develops, manufactures and markets unique Generic and Branded products often unmatched by competitors.
Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 211084
- 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.
- 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.