Swyssi, for now, is mainly active in Europe with a focus on EU countries. Among the prescription drug approvals are:
Rossta/Rosi (rosuvastatin calcium)
Candesartan HCT Swyssi (candesartan/hydrochlorothiazide)
Amarhyton (flecainide acetate)
Medicines, treatments and cures in our portfolio challenge the most socially significant diseases of our time and are developed and manufactured in accordance with GLP and cGMP stringent standards and the requirements of Pharmacovigilance.
Research & laboratory development, formulating and characterization, and manufacturing of complex generic drug products and particularly the regulatory requirements mandated Swyssi to partner in successful navigation of complex AIPs, formulations, dosage forms, national routes of administration, analytical challenges, manufacturing and particularly in novel technologies for demonstrating bioequivalence.
Made affordable, mass medication care secures getting ahead of ageing. Compliant adherence to wellness and all other forms of happy and high quality life of billions follows everywhere on the planet.
FDA recognized the multiple benefits of complex generic drug applications for improving access to medications and lowering healthcare costs, and introduced a simplified approval pathway with reduced number of review cycles.
Difficult to reproduce, complex drug products are generally defined by FDA Commissioner Scott Gottlieb as having ‘at least one feature that makes them harder to “genericize” under our traditional approaches’. These features, in development and laboratory processes can arise from formulation procedure or compounds, characterization or sequences and/or manufacturing considerations.
Robust generic and soon complex generic drug penetration in the US is a result of FDA Drug Competition Action Plan. In Europe similarly the access to lower cost modernized alternatives of once innovative pharmaceuticals with lapsed patent and market exclusivity has a long tradition, now reaffirmed and accelerated by the novelty combo medications.