TIEFENBACHER PHARMACEUTICALS announces global launch of Teriflunomide making multiple sclerosis therapy more affordable and better available worldwide

TIEFENBACHER PHARMACEUTICALS, part of TIEFENBACHER GROUP, has successfully developed a global dossier for a generic version of Teriflunomide 7 mg and 14 mg film-coated tablets.  

 Teriflunomide is an important part of the therapy of multiple sclerosis 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. Additional filings in Europe, South America and South Africa are under preparation and will take place this year in line with data exclusivity expiry.  

For further information please contact TIEFENBACHER PHARMACEUTICALSinfo@aet.eu 

Disclaimer: Teriflunomide, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force. 


AET Pharma US Inc. Announces Successful approval of generic Posaconazole by the Food and Drug Administration (FDA)

On 1st February 2021, AET Pharma US Inc, part of TIEFENBACHER GROUP, received FDA approval of the Abbreviated New Drug Application (ANDA) for Posaconazole 100 mg Delayed-Release Tablets. This is another milestone for TIEFENBACHER GROUP in further strengthening its product portfolio in the United States. The US launch of Posaconazole will proceed in close cooperation with our experienced distribution partner, Lupin Pharmaceuticals Inc. With the market entry of Posaconazole, we look forward to increasing availability and ensuring affordability of this treatment for American patients.

The product has been developed by and is manufactured at TIEFENBACHER LABORATORIES in Hyderabad, India, and has already been successfully launched in the European Union and in Australia. The registration dossier is currently under filing in several additional international markets.

For more information, please contact TIEFENBACHER PHARMACEUTICALS: info@aet.eu


TIEFENBACHER PHARMACEUTICALS Announces Global Launch Of Rivaroxaban

TIEFENBACHER PHARMACEUTICALS, part of Tiefenbacher Group, is pleased to announce the availability of a registration dossier for the generic of Rivaroxaban 2.5 mg, 10 mg, 15 mg and 20 mg film-coated tablets.
The product was developed at TIEFENBACHER LABORATORIES, Hyderabad. Commercial production for early markets is conducted outside of Europe. For European markets, the product will be manufactured at TIEFENBACHER GROUP facility on Cyprus.

The formulation has successfully passed fifteen global bioequivalence studies and six additional pivotal studies are currently under preparation. The registration dossier is currently approved in several EU markets via DCP and via national applications in CIS countries and in Canada.

The product has already been successfully launched in early markets and further markets will follow during the course of this year. The registration dossier is under filing in several additional international markets with a global roll out to follow in more than sixty markets throughout the world.

The market exclusivity and basic patent have already expired, while the SPC will expire in September 2023 in Europe.

For more information, please contact TIEFENBACHER PHARMACEUTICALS: info@aet.eu

Disclaimer: Rivaroxaban, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force.


International Brand Relaunch of TIEFENBACHER GROUP

“We are very excited to launch our new AET website, representing the pharmaceutical FDF business of TIEFENBACHER GROUP. It is an important milestone within the international brand relaunch of our whole company group (www.tiefenbachergroup.com) and represents the fundamental changes which we have started in the recent years. We are on the move to drive important efficiencies in our supply chain and become a more and more innovative, patient-centered enterprise with a global pharmaceutical footprint.”

Oliver Schrader and Dr. Kristian Ruepp, Managing Directors AET

“We are very excited to launch our new AET website, representing the pharmaceutical FDF business of TIEFENBACHER GROUP. It is an important milestone within the international brand relaunch of our whole company group (www.tiefenbachergroup.com) and represents the fundamental changes which we have started in the recent years. We are on the move to drive important efficiencies in our supply chain and become a more and more innovative, patient-centered enterprise with a global pharmaceutical footprint.”

Oliver Schrader and Dr. Kristian Ruepp, Managing Directors AET


Tiefenbacher Group and OnDosis enter a strategic partnership for game-changing integration of medicines and digital health

Tiefenbacher Group and OnDosis today announced the signing of an extensive co-development agreement for multiple products in the upcoming years. This collaboration strengthens both companies’ commitment to further develop and commercialize innovative products within individualized treatments and digital health, combining traditional drug-based medicines with digital therapeutics and intelligent dosing.