TIEFENBACHER PHARMACEUTICALS announces global generic launch of Teriflunomide – making multiple sclerosis therapy more affordable and better available worldwide
Tiefenbacher Pharmaceuticals has successfully developed a global dossier for a generic version of Teriflunomide 7 mg and 14 mgfilm-coated tablets. Generics are therapeutically equivalent to their branded counterparts with a lower price due to losing patent protection. Teriflunomide is an important part of the therapy of Multiple Sclerosis (MS) and the global roll-out of the product in more than 40 countries will make this therapy more affordable and better available for the over 2,8 million patients worldwide. The product was developed and is commercially produced at our Indian manufacturing site TIEFENBACHER LABORATORIES in Hyderabad and at Combino Pharm Ltd. The formulation has successfully passed four bioequivalence studies against reference products from three different markets. The product is already approved in Australia, Canada, New Zealand, and the US – all with strict US Food and Drug Administration (FDA) standards. Additional filings in Europe, South America and South Africa are under preparation and will take place this year in line with data exclusivity expiry.
Disclaimer: Teriflunomide, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force.
TIEFENBACHER PHARMACEUTICALS, a part of Tiefenbacher Group, develops and commercializes generic, value added, and innovative pharmaceuticals as well as medical devices worldwide. We provide over 180+ pharmaceutical products across various therapeutic categories in 10+ dosage forms. With our in-house product development and manufacturing, we can address specific therapeutic needs in unique formulations of prescription drugs (Rx) and over-the-counter (OTC) medicines for global markets (including highly potent drugs).
For more information about our finished dosage forms and healthcare solutions, please contact Tiefenbacher Pharmaceuticals: info@tiefenbacher.com or please visit us on: www.tiefenbacher-pharmaceuticals.com
About Tiefenbacher Group – Pioneering Healthcare since 1963
Tiefenbacher Group is a purpose-driven and 100% family-owned healthcare company providing best-in-class solutions along the entire pharmaceutical value chain. From the initial idea to market access of high-quality medicines around the world: We distribute APIs and develop, produce, and register finished dosage forms (FDFs) including highly potent drugs as well as medical devices. Our purpose is to improve people’s lives by making pharmaceuticals more affordable, more available, and better than ever before.
For further information about TIEFENBACHER GROUP and our solutions for better healthcare and our in-house capabilities to develop and commercialize pharmaceutical products for global markets (including highly potent drugs) please contact us by email at info@tiefenbacher.com or visit us on: www.tiefenbachergroup.com
