Founded in Sweden in 2004 as Pharmalink AB, Calliditas Therapeutics develops and commercializes medicines for rare diseases, with an initial focus on kidney and liver disorders. The company pioneered the first treatment specifically designed for IgA nephropathy and markets TARPEYO in the United States, while partners commercialize related therapies in other regions.
United States Food and Drug Administration full approval for TARPEYO
Registration
European Commission full marketing authorization for Kinpeygo
Registration
FDAAPPROVAL
Quality certification
Leadiant Biosciences, IncFrom its Rockville base, Leadiant Biosciences develops and distributes prescription therapies for people living with rare diseases. The private U.S. pharmaceutical company draws on a longstanding heritage in orphan-drug development, becoming the fourth company in the world to receive a U.S. Orphan Drug Designation in 1984. Its research teams work with physicians, researchers, academic institutions and biotechnology organizations, while patient-support programs provide education and resources beyond the medicine itself.ROCKVILLE, MD
SERB PharmaceuticalsSERB Pharmaceuticals develops, manufactures, and supplies specialist medicines for rare diseases and medical emergencies, with a particular strength in antidotes and other critical-care treatments. Beginning in the 1950s as Société d’Études et de Recherches Biologiques, the company now supplies more than 70 medicines through direct operations and distribution partners in over 100 countries. Its fully integrated platform includes a commercial-scale polyclonal antibody manufacturing capability and four manufacturing facilities across three continents.325412CONSHOHOCKEN, PA
Nobelpharma America, LLCEstablished in Bethesda in 2019 as the first global subsidiary of a Japanese pharmaceutical company founded in Tokyo in 2003, Nobelpharma America develops and brings medicines and medical devices to U.S. patients with rare or underserved conditions. Its purpose is to pursue treatments that larger companies may overlook because few patients are affected or existing options are limited. The company works with worldwide experts to move essential therapies from development toward patients, caregivers, and health care providers.BETHESDA, MD
ZyVersa Therapeutics, IncFounded by Stephen C. Glover, ZyVersa Therapeutics is a clinical-stage specialty biopharmaceutical company built around licensed technologies from University of Miami Miller School of Medicine researchers. The company develops medicines for patients with serious inflammatory and renal diseases, with its work centered on unmet medical needs rather than established treatments.WEST CONSHOHOCKEN, PA