Tiefenbacher Pharmaceuticals successfully prepares the launch of Varenicline in the European Union
We at Tiefenbacher Pharmaceuticals strongly believe that our high-quality medicines should be available and affordable for patients all around the world. That´s why we are thrilled to share that we have successfully prepared the launch of the only available Varenicline containing product in Europe.
WHO has added Varenicline to the list of essential medicines in 2021. This medicine is a cornerstone of the smoking cessation therapy helping patients to stop smoking in a short period of time (12 to 24 weeks).
Nevertheless, the originator brand Champix had to be withdrawn from the market in the same year due to the formation of nitrosamines in the manufacturing process. The European Medicines Agency has set clear quality standards for the product. Those need to be fulfilled before this important medicine could be made accessible again. Since then, Varenicline was not available to the ~117,7 million smokers in Europe anymore.
Tiefenbacher Pharmaceuticals brings the smoking cessation molecule Varenicline back to European patients.
In the last years, Tiefenbacher Group has successfully completed the formulation in its laboratories in Hyderabad, India. We are proud that we are the first who meet the European quality criteria. Together with our partners we are ready to be the first supplier that brings back Varenicline to smoking cessation patients in Europe.
Varenicline Citrate film coated tablets are marketed in the strengths 0,5 mg and 1 mg by our partners. This launch will not only improve the life of patients but also bring significant cost reduction for the healthcare systems. Untreated smoking addiction leads to a variety of follow-up diseases like premature atherosclerosis or coronary artery disease.
This launch reflects our ongoing commitment to providing patients with high-quality, affordable medicines. It is also a testament to the hard work and commitment of our team. We are excited about the positive impact this achievement will make.
TIEFENBACHER PHARMACEUTICALS, a part of Tiefenbacher Group, develops and commercializes generic, value added, and innovative pharmaceuticals as well as medical devices and e-health-solutions 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.
For more information about our finished dosage forms (FDF) including highly potent drugs and e-healthcare solutions, please contact us at info@tiefenbacher.com or 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. We are 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 and e-health solutions. The 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 please contact us by email at info@tiefenbacher.com or visit us on: www.tiefenbachergroup.com
