Indian pharmaceutical company Themis Medicare has joined hands with French biotech company NFL Biosciences to develop NFL-101, a drug candidate for smoking cessation for the Indian market.
Themis Medicare submitted an investigational new drug application for NFL-101 phase 2/3 clinical trial to the Central Drugs Standard Control Organization, the National Regulatory Authority of India.
After the approval, the clinical trial will be done in India targeting 334 smokers. The expenses of the process from submission to completion of the study will be borne by Themis Medicare.
The NFL-101 active pharmaceutical ingredient will be bought by Themis Medicare from NFL Biosciences with the latter also to get double-digit royalties on sales.
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