Glenmark gets CDSCO panel nod for manufacturing, marketing Itraconazole Capsules
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharma major Glenmark Pharma for manufacturing and marketing of Itraconazole Capsules 130mg indicated for the treatment of specified fungal infections in immunecompromised and nonimmunocompromised adult patients.
The nod came after the firm presented the bioequivalence (BE) study report of Itraconazole Capsules 130mg before the committee.
Itraconazole is a broad spectrum triazole antifungal agent which is available as both oral and i.v. formulations. Itraconazole inhibits fungal cytochrome P450 enzymes preferentially, resulting in a reduction in fungal ergosterol production. This drug can be utilised for long-term maintenance treatment of chronic fungal infections due to its minimal toxicity profile.
Itraconazole is used as an antifungal drug for the treatment of various fungal infections, including aspergillosis, blastomycosis, candidiasis, chromoblastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, and sporotrichosis.
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