Stempeutics enlists Cipla collaborate for launch of Stempeucel for CLI

India’s Stempeutics Research has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel in India, which will be achieved under a partnership with generics major Cipla (BSE: 500087).

The product is indicated for the treatment of critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease. It is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment.

The product has been developed by Stempeutics over a period of 12 years. The company’s proprietary pooling approach provides for an efficient manufacturing process thereby enabling the product to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients. The proprietary technology also helps Stempeucel extend the therapeutic potential of the drug across multiple disease categories.