Stempeutics receives ATMP classification from EMA for its novel stem cell drug Stempeucel

23 Mar 2015 Evaluate

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

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. The regulation provides guidelines to research development companies for following a standardized process in order to obtain approval in EU countries.

Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 170 countries. Its portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally.

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