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Cipla partner Stempeutics gets DCGI nod for stem cell-based product

The company's goal is to globalise its product, Stempeucel, for Buerger's Disease, the company's CEO said

Press Trust of India  |  New Delhi 

Drugs, Pill, Medicine, Tablet

Biotechnology firm 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.

CEO B N Manohar said: "Obtaining DCGI approval for Stempeucel is an important and historic milestone for 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 $1.5 billion worldwide, he added.

"Through 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 therapy in their hand to fight Buerger's Disease," 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 in 2009 and is now a joint-venture firm.

First Published: Mon, May 30 2016. 13:42 IST