GuficBiosciences gets Central Drug Control nod for manufacture of anti-fungal drugs

Gufic Biosciences Limited (Gufic)has received permission from Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare for manufacture, sale and distribution of Isavuconazonium Sulfate API and finished formulation Isavuconazole for Injection 200 mg/vial. 

Isavuconazole for Injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis.

Mr. Nagesh Y., Chief Operating Officer, Gufic Biosciences Ltd said “Isavuconazole is a systemic antifungal drug of triazole class. Isavuconazole is already approved by US-FDA on March 06, 2015 and European Medicines Agency (EMA) on October 15, 2015. The incidence of invasive fungal infections has been increasing over the past few decades and represents a significant problem in immune compromised individuals and a large proportion of critically ill patients. 

Also, during the second wave of Covid-19, there has been a significant increase in number of cases of Mucormycosis in covid-19 patients across India during treatment in hospitals and after discharge. This is where Isavuconazole has come as a boon for these patients..