Gufic Biosciences gets CDSCO nod to market drug for severe fungal infections

Gufic Biosciences yesterday said it has received an approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market a drug used to treat invasive aspergillosis and mucormycosis.

The company has received approval for the production, sale and distribution of Isavuconazonium Sulfate API and finished formulation Isavuconazole for injection 200 mg/vial, the company said in a statement.

Isavuconazole for injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and above

”Isavuconazole is a systemic anti-fungal drug of triazole class. Isavuconazole is already approved by USFDA on March 6, 2015 and European Medicines Agency (EMA) on October 15, 2015,” Nagesh Y, Chief Operating Officer, Gufic Biosciences, noted.

The incidence of invasive fungal infections has been increasing over the past few decades, and it represents a significant problem in immuno-compromised individuals and a large proportion of critically-ill patients, he added.

”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,” Nagesh Y stated.

Besides India, Gufic is expanding presence in Germany, Switzerland, South Africa, Russia, Canada, Europe and other key countries within the emerging market territories.