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March 2014
Sigmapharm completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 205569.
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September 2013
Sigmapharm launches, exclusively under its own label, its 10th generic product, Adefovir Dipivoxil Tablets, 10 mg, which is the first-and-only approved generic equivalent to Gilead’s HEPSERA® Tablets.
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August 2013
- 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 2nd Paragraph-IV filing).
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April 2013
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).
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March 2013
- Sigmapharm launches, exclusively under its own label, its 9th 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.
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December 2012
Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 8th generic product, Griseofulvin Tablets, USP (microsize) 500 mg, which is the first-and-only approved generic equivalent to GRIFULVIN-V® Tablets.
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November 2012
- Sigmapharm launches its 7th generic product, Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, exclusively under its own label. This is the company’s 1st 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 6th generic product, Utramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, which is the first-and-only approved generic equivalent to GRIS-PEG® Tablets.
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October 2012
- 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.
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August 2012
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 204633).