New Delhi: Biotechnology firm Stempeutics Research has received limited approval from the national drug regulator, DCGI, for its stem cell based product Stempeucel for treatment of Buerger’s Disease. “The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger’s Disease,” Cipla, which has investments in Stempeutics, said in a statement.
Stempeutics CEO B N Manohar 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.” The company’s goal is to globalise Stempeucel for Buerger’s Disease and the market size is approximately USD 1.5 billion worldwide, he added.
“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,” Cipla New Ventures Head Chandru Chawla said.
Buerger’s Disease is a recurring progressive inflammation and clotting of small and medium arteries and veins of the feet.
The Bengaluru-based Stempeutics Research was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into a strategic alliance with Cipla in 2009 and is now a JV firm.
