Sigmapharm Laboratories

Innovative Pharmaceutical Technologies Maximizing Drug Therapy

Mission Statement

We, at Sigmapharm Laboratories, develop, manufacture and market unique, cost effective, high barrier-to-entry generic and branded drug products that are often unmatched by our competitors.  Our proprietary technology platforms, ability to innovate, modern and state-of-the-art equipped facilities, transparent and effective quality systems and highly specialized personnel enable us to almost exclusively develop, manufacture and market high-quality: (i) unique generic products with or without Paragraph-IV patent challenges designed either to not infringe the Orange Book patents of their reference products or to overcome complicated bioavailability and stability issues; and (ii) new branded products of already approved and commercialized drugs associated with new significantly improved formulations, new therapeutic indications or more convenient administration schedules.  We are indeed a unique, specialty pharmaceutical company by design, and our potential for success is virtually unlimited. 

Spiro Spireas, Ph.D.

Founder, Chairman and Chief Executive Officer

 

Core Targets

Uniqueness

 

  

 

Our Unique Product Selection process is primarily focused on the degree of difficulty in formulating the ideal candidate chosen for development.  Only drug products with high barrier-to-entry attributes enter our research and development pipeline.  Several of our marketed products have been facing minimum or no generic competition.  And, our current pipeline reasonably anticipates that this trend of developing first-to-market, one-source products will be continuing for years to come.  

 

Quality

 

 

 

We always put patients and customers first and earn their trust by focusing on quality and reliability.  The company has been built on the objective of producing high-quality products based on the scalability and manufacturability of our formulations, the effectiveness and transparency of our quality systems, the integrity, expertise and training of our employees, and a keen eye on customer and patient service.

Safety

 

 

 

We see health and safety as an organizational pillar.  We are committed to very high standards of environmental, health and safety performance.  In doing so, our expectation is an injury-free workplace and an assurance that our activities do not result in any adverse safety, health or environmental impacts either on or off site. 

 

Responsibility

 

 

 

We have always been committed to high standards of ethical conduct in our business and in our dealings with other organizations.  At the heart of this are our core values: innovation, integrity, excellence, transparency, and respect.  We aim to be the best-in-class corporate citizen through our unique and high-quality products, our reliable product supply chain, and our transparency with customers and patients alike.

Our History

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)

Facilities

Sigmapharm Laboratories occupies four buildings located at the northeast region of Philadelphia with direct access to major routes and highways. Our 250,000 sq. ft. facilities contain fully equipped research and development, analytical testing, manufacturing, packaging and warehousing areas organized with modern and efficient operational flow configurations and regulatorily compliant systems. Our facilities are constantly updated with new, accurate and efficient, state-of-the-art analytical chemistry, physical chemistry, formulation, manufacturing and packaging equipment controlled by fully traceable and protected networks and computer-server systems.