Sigmapharm Laboratories, LLC, a privately held specialty pharmaceutical company, develops, manufactures and markets unique Generic and Branded products often unmatched by competitors.
Sigmapharm receives FDA approval for generic Ambrisentan Tablets, 5 mg and 10 mg, based on its ANDA No. 208354 containing a Paragraph IV certification.
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.