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COVID-19: Glenmark Pharma becomes the first company to get Nod from DCGI for clinical trials of Favipiravir tablets

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On April 30, 2020, Glenmark Pharmaceuticals, Mumbai, Maharashtra, became the first pharma company in India to receive approval from Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients.Glenmark Pharma gets DCGI nod for clinical trials of Favipiravir tabletsKey Points:

i.About Favipiravir: The Favipiravir antiviral drug is used in few countries for the treatment of Coronavirus. The drug sold under brand name Avigan by Fujifilm Toyama Chemical has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.

ii.Fujifilm has started phase 3 trial on this drug and also increased its production.

iii.Another Indian company, Strides Pharma said that it has already started shipping the drug to countries in the Gulf region.

iv.Glenmark Pharmaceuticals had internally developed the active pharmaceutical ingredient (API) and the formulations for the product. The regulator (DCGI) has given approval for conducting the trial on mild to moderate patients.

v.Clinical trial: As per the clinical trial approval approved, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care.

vi.The treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization.

vii.Sushrut Kulkarni, Executive Vice President– Global R&D (Research and Development), added that the clinical trial will let us know the efficacy of this molecule on COVID-19 patients.

About Glenmark Pharmaceuticals:
Headquarters– Mumbai, Maharashtra.
Chairman & Managing Director (MD)– Gleen Saldanha.
Founder– Gracias Saldanha.