Archive - 2009

• Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 091004.


• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 200295).

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 091619).

Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 1^st generic product, Amiloride Hydrochloride Tablets, USP 5 mg, which is the second approved generic equivalent to MIDAMOR^® Tablets.

Sigmapharm receives FDA approval for generic Amiloride Hydrochloride Tablets, USP 5 mg, based on its ANDA No. 079133.  This is our 1^st ANDA approval.