News & Events

July 2015
  • Sigmapharm files two Abbreviated New Drug Applications with paragraph IV certifications.
May 2015
  • Sigmapharm receives approval from FDA for Acitretin Capsules, USP 10 mg, 17.5 mg, 22.5 mg and 25 mg.
April 2015
  • Sigmapharm files an Abbreviated New Drug Application with paragraph IV certification.
September 2014
  • Forest Laboratories LLC has sued Sigmapharm Laboratories LLC to halt the production of a generic equivalent of antipsychotic drug Saphris Tablets. click here
June 2014
  • Sigmapharm files a Drug Master File for Amorphous Dofetilide (DMF #028301).
  • Sigmapharm files an Abbreviated New Drug Application with paragraph IV certification.
  • Sigmapharm files an Abbreviated New Drug Application with paragraph IV certification.
  • Sigmapharm files an Abbreviated New Drug Application.
  • Sigmapharm files an Abbreviated New Drug Application.
April 2014
  • Sigmapharm voluntarily conducts a recall for four lots of Liothyronine Sodium Tablets, USP 5 mcg. click here
September 2013
  • Sigmapharm launches Adefovir Dipivoxil Tablets, 10 mg.
August 2013
  • Sigmapharm receives approval from FDA for Adefovir Dipivoxil Tablets, 10 mg.
  • Sigmapharm files its second Drug Master File (DMF).
  • Sigmapharm files an Abbreviated New Drug Application with paragraph IV certification.
March 2013
  • Sigmapharm receives approval from FDA and launches Sodium Phenylbutyrate Powder.
November 2012
  • Sigmapharm receives approval from FDA and launches Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg. click here...
  • Sigmapharm launches Griseofulvin (ultramicrosize) Tablets, USP 125 mg and 250 mg.
October 2012
  • Sigmapharm receives approval from FDA for Griseofulvin (microsize) Tablets, USP 500 mg.
  • Sigmapharm receives approval from FDA for Griseofulvin (ultramicrosize) Tablets, USP 125 mg and 250 mg.
August 2012
  • Sigmapharm files an Abbreviated New Drug Application that has been granted priority review status.
November 2011
  • Sigmapharm launches Flucytosine Capsules, USP 250 mg and 500 mg.
June 2011
  • Sigmapharm receives approval from FDA for Flucytosine Capsules, USP 250 mg and 500 mg.
April 2011
  • Sigmapharm launches Disulfiram Tablets, USP 250 mg for commercial marketing.
March 2011
  • Sigmapharm receives approval from FDA for Disulfiram Tablets, USP 250 mg and 500 mg. click here...
February 2011
  • Sigmapharm files its 10th Abbreviated New Drug Application.
November 2010
  • Sigmapharm files its 9th Abbreviated New Drug Application.
  • Sigmapharm files its 8th Abbreviated New Drug Application.
October 2010
  • Gilead Sciences Inc. has sued Sigmapharm Laboratories LLC over its attempt to introduce a generic version of chronic hepatitis B drug Hepsera. click here...
August 2010
  • Gilead Sciences Inc. receives Hepsera ANDA Filing notification by Sigmapharm Laboratories LLC. click here...
July 2010
  • Sigmapharm launches Ergocalciferol Capsules, USP 1.25 mg for commercial marketing through
    Rising Pharmaceuticals, Inc.
  • Sigmapharm receives approval from FDA for its third product - Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D).
June 2010
  • Sigmapharm launches Protriptyline HCl Tablets, USP 5 mg and 10 mg for commercial marketing
    through Rising Pharmaceuticals, Inc.
  • Sigmapharm files its 7th Abbreviated New Drug Application which contains a paragraph IV certification.
    This is the company's first paragraph IV filing
    .
  • Sigmapharm files its first Drug Master File for Amorphous Adefovir Dipivoxil (DMF #02384).
May 2010
  • Sigmapharm receives approval from FDA for its second product - Protriptyline HCl Tablets, USP 5 mg and 10 mg.
February 2010
  • Sigmapharm files its 6th Abbreviated New Drug Application.
September 2009
  • Sigmapharm passes its second FDA inspection.
  • Sigmapharm files its 5th Abbreviated New Drug Application.
July 2009
  • Sigmapharm files its 4th Abbreviated New Drug Application.
April 2009
  • Sigmapharm launches its first product, Amiloride HCl Tablets, USP 5 mg, for commercial marketing
    through Rising Pharmaceuticals, Inc.
January 2009
  • Sigmapharm receives approval from FDA for its first product - Amiloride HCl Tablets, USP 5 mg.
November 2008
  • Sigmapharm files its 3rd Abbreviated New Drug Application.
May 2008
  • Sigmapharm files its 2nd Abbreviated New Drug Application.
January 2008
  • Sigmapharm passes its first FDA inspection.
June 2007
  • Sigmapharm files its 1st Abbreviated New Drug Application.
August 2006
  • Sigmapharm moves to a new 60,000 sq. ft. facility in Bensalem, Pennsylvania.