AboutSigmapharm Laboratories, LLC
Sigmapharm Laboratories was founded by Dr. Spiro Spireas on March 1, 2005. We first moved to a 5,000 sq. ft. space in Langhorne, PA, and by September 15, 2006, we moved to our current main building in Bensalem, PA. Over the next decade, we expanded and acquired additional operational space of more than 250,000 sq. ft. We started in 2005 as a small, specialty formulation house conducting only pilot-scale development of unique, difficult-to-formulate products using proprietary drug delivery systems. By the start of 2007, we became capable of large-scale product development, permitting us since then to initiate our regulatory filings to the FDA. By mid-2010, our new proprietary technology platforms, scientific expertise and ability to innovate resulted in submitting several Paragraph-IV filings to the FDA. And, by the end of 2012, our own Sales & Marketing team started launching all of our new products exclusively under Sigmapharm’s own label.
Historic Milestones:
Jun. 2007: First ANDA Submission (Amiloride Hydrochloride Tablets)
Jan. 2008: First GMP Inspection completed by the FDA
Jan. 2009: First ANDA Approval (Amiloride Hydrochloride Tablets)
Apr. 2009: First Product Launch (Amiloride Hydrochloride Tablets)
Jun. 2010: First DMF Submission (Adefovir Dipivoxil, Amorphous)
Aug. 2010: First ANDA Submission with a First-to-File Paragraph-IV Certification (Adefovir Dipivoxil Tablets)
Oct. 2010: First Paragraph-IV Litigation initiated against Sigmapharm by Gilead Sciences, Inc., for generic Adefovir Dipivoxil Tablets equivalent to HEPSERA® Tablets
Nov. 2012: First Product Launch exclusively under Sigmapharm’s Own Label (Liothyronine Sodium Tablets)
Aug. 2013: First FDA approval of an ANDA containing a Paragraph-IV Certification (First-and-Only generic Adefovir Dipivoxil Tablets equivalent to HEPSERA® Tablets)
Sep. 2013: First Product Launch of a First-to-File Paragraph-IV product (First-and-Only generic Adefovir Dipivoxil Tablets equivalent to HEPSERA® Tablets)
