News & Events

Sigmapharm completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 205569.

Sigmapharm launches, exclusively under its own label, its 10^th generic product, Adefovir Dipivoxil Tablets, 10 mg, which is the first-and-only approved generic equivalent to Gilead’s HEPSERA^® Tablets.

• Sigmapharm receives FDA approval for generic Adefovir Dipivoxil Tablets, 10 mg, based on its ANDA No. 202051 containing a First-to-File Paragraph-IV certification.


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


• Sigmapharm files a Drug Master File for Amorphous Asenapine Maleate (DMF No. 027300). 


• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 206107) which includes a Paragraph-IV certification (our 2^nd Paragraph-IV filing).

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).

• Sigmapharm launches, exclusively under its own label, its 9^th generic product, Sodium Phenylbutyrate Powder in 250-g-fill Bottles, which is the first-and-only approved generic equivalent to BUPHENYL^® Powder.


• Sigmapharm receives FDA approval for generic Sodium Phenylbutyrate Powder in 250-g-fill Bottles, based on its ANDA No. 202819.

Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 8^th generic product, Griseofulvin Tablets, USP (microsize) 500 mg, which is the first-and-only approved generic equivalent to GRIFULVIN-V^® Tablets.

• Sigmapharm launches its 7^th generic product, Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, exclusively under its own label.  This is the company’s 1^st generic product marketed solely under Sigmapharm’s own label.


• Sigmapharm receives FDA approval for generic Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, based on its ANDA No. 200295.   


• Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 6^th generic product, Utramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, which is the first-and-only approved generic equivalent to GRIS-PEG^® Tablets.

• Sigmapharm receives FDA approval for generic Griseofulvin Tablets, USP (microsize) 500 mg, based on its ANDA No. 202482.


• Sigmapharm receives FDA approval for generic Utramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, based on its ANDA No. 202545.

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 204633).

Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 202819.