Advanced Therapy Medicinal Product classification from EMA for Stempeutics

Stempeutics Research, a group company of Manipal Education and Medical Group and a Joint Venture with Cipla Group, received a classification as “Advanced Therapy Medicinal Product” (ATMP) from  the European Medicines Agency (EMA) for its novel stem cell drug .

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Stempeucel which will be used for the treatment of Thromboangiitis Obliterans (TAO). The ATMP classification, approved by the committee for Advanced Therapies (CAT) of the European Medicines Agency, will allow Stempeutics to commercialize the product ‘Stempeucel’ across the European Union region. Thromboangiitis Obliterans is a recurring progressive inflammation and thrombosis (clotting) of small and medium arteries and veins of the feet.

The aim of the ATMP classification is to regulate cell and gene therapy and tissue engineered medicinal products, providing a benchmark for a level of quality compliance for pharmaceutical practices.

Commenting on the ATMP classification, Mr B N Manohar, CEO of Stempeutics said, “We are happy to receive ATMP status from the EMA. We view this as an important milestone to further develop our novel stem cell biological drug Stempeucel in the EU for treating Thromboangiitis Obliterans indication. Additionally, we interpret this as a favourable indication for how the European regulators view our therapy.” 

This is the First Stem Cell Drug Based on Pooling Technology to be Granted ATMP Classification. This allows to be sure on quality standards are well consistently applied and adequately monitored.

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