DCGI gives limited approval to market FIRST Allogeneic cell therapy product in India

Stempeutics puts India on the 'World map of Regenerative Medicine'.

Commenting on the approval of DCGI, Mr BN Manohar, CEO of Stempeutics said: "Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. We are the first company in India to achieve such approval. It took almost 9 years to develop Stempeucel for the treatment of Buerger's Disease. European Medicinal Agency has classified Stempeucel as an Advanced Therapeutic Medicinal Product (ATMP) and designated it as an Orphan Drug (ODD) for the treatment of Buerger's Disease. Our goal is to globalize Stempeucel for Buerger's Disease and the market size is approximately $1.5 Billion worldwide".

Mr Chandru Chawla Head Cipla New Ventures sai: "Today is not only a great day for Stempeutics, but for everyone involved in the responsible development of stem cell therapies. Through Cipla Group's investment in Stempeutics, we have brought the next generation of biologics to address unmet medical needs. Physicians now have an off-the-shelf stem cell therapy in their hand to fight Buerger's Disease. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."

"It is a significant milestone for Stempeutics and a satisfying journey for Manipal Education and Medical Group," commented Dr H. Sudarshan Ballal, Chairman - Manipal Hospitals