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Glenmark Pharmaceuticals receives DCGI (India) approval
Source: Capital Market, Wednesday, December 28th, 02:43 PM
Glenmark Pharmaceuticals has received DCGI (India) approval for conduct of pivotal study of 'Crofelemer' in acute watery diarrhoea patients. Post approval from the DCGI, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel group, three arm, multicenter and multinational pivotal study that is being carried out to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe acute watery diarrhoea in adult patients including cholera. This phase III study will be done at leading centres in India and Bangladesh.
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