Recognitions
We are honored to be recognized for our accomplishments in the area of stem cell technology and its application.
Innovator of the Year Award 2022
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Patents
Stempeucel® process patent bas been granted in 18 countries including USA, Japan, China, Singapore, Australia, New Zealand, UK, France, Germany, Italy and South Africa
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ISO 9001:2015
Stempeutics has been awarded ISO 9001:2015 certification for Development and Manufacturing of Mesenchymal Stromal Cell Based products for commercial use and for clinical trial use.
Commercial Use: For DCGI Approved Indications
Clinical Trial Use: For Chosen Indications: Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Diabetic Foot Ulcer (DFU)
Commercial Use: For DCGI Approved Indications
Clinical Trial Use: For Chosen Indications: Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Diabetic Foot Ulcer (DFU)
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ATMP & ODD Status in Europe:
Stempeucel® has been classified as an ATMP product and designated as an Orphan Drug for the treatment of CLI due to Buerger's Disease by EMA
Recognised Nationally by
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DSIR
Stempeutics Bangalore and Manipal R&D units have been recognised by Department of Scientific and Industrial Research (DSIR), Government of India
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DCGI
Stempeutics Manipal facility has been approved by DCGI for clinical trial manufacturing (Form 29) as well as for commercial manufacturing (Form 28)
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ABLE
BN Manohar is the Chairperson of ABLE (Association of Biotechnology Led Enterprise – India) – Regenerative Medicine sub-committee
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COPP
Certificate of a Pharmaceutical Product has been granted by State drug control department
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ISCT
Stempeutics has been awarded ISCT 2022 Top Scoring Emerging Economy Abstract Award
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NAC-SCRT
IC-SCR approved by NAC-SCRT
