Genus Lifesciences, founded in 1999, is a manufacturer of branded and generic pharmaceutical products, headquartered in Allentown PA. Genus Lifesciences is one of the leading companies in the United States successful in obtaining FDA approval for illegally marketed unapproved drugs. Addressing the regulatory concern of unapproved drugs, Genus Lifesciences performs the necessary clinical and non-clinical studies to ensure that unapproved drugs are safe and effective, thereby aiding the effort for unapproved drugs to be removed from commerce.
Founded in 1999, Genus Lifesciences™ employs over one hundred fifty professionals in all phases of pharmaceutical operations, and its products are available in pharmacies and other retail outlets throughout the United States. In addition to its local presence, Genus Lifesciences™ has on-going research efforts through global partnerships related to its technology platforms.
NDA
Genus Lifesciences is a national leader in the submission of 505(b)(2) New Drug Applications, for products previously sold as Unapproved Products.
Diversion and Abuse Resistant Technologies (DART) allows dosage manufacturers to improve a product’s resistance to abuse, illegal diversion, and potential overdose.