Biotechnology firm Stempeutics Research has received limited approval from the national drug regulator, Drug Controller General of India (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.
The company's goal is to globalise Stempeucel for Buerger's Disease and the market size is approximately $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 in 2006 and later entered into a strategic alliance with Cipla in 2009 and is now a joint-venture firm.