Cipla’s partner gets DCGI nod to launch Stempeucel for CLI treatment

21 Aug 2020 Evaluate

Cipla’s partner -- Stempeutics Research has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel in India. The product is indicated for the treatment of 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 twelve 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. Under the agreement signed between the two companies, Cipla has received exclusive rights to market and distribute the product in India by leveraging its expansive distribution strengths across the country.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.

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