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Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections

Ruchika SharmaWritten by Ruchika Sharma   |  
Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections
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Isavuconazole for Injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and above.

New Delhi: Gufic Biosciences on Monday 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 antifungal drug of triazole class. Isavuconazole is already approved by USFDA on March 6, 2015 and European Medicines Agency (EMA) on October 15, 2015," Gufic Biosciences Chief Operating Officer Nagesh Y noted.
The incidence of invasive fungal infections has been increasing over the past few decades and it represents a significant problem in immunocompromised 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.

Read also: Dr. Reddy's gets CDSCO panel nod to study Fosravuconazole L Lysine Ethanolate Capsule

Gufic group has been in the Pharmaceutical industry since 1970. The group is one of the largest manufacturers of Lyophilized injections in India and have a fully automated lyophilization plant. Its lyophillized product portfolio includes Antibiotic, Antifungal, Cardiac, Infertility, Antiviral and proton-pump inhibitor segments. Gufic products are supplied to most hospital chains and medical facilities.

Read also: Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab

cdscogufic biosciencesgufic biosciences newsinvasive aspergillosismucormycosisisavuconazonium sulfate apisavuconazole for injectionusfda
Source : with inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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