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.
Glenmark sells Itraconazole Capsules 100 mg under the brand names Syntran 100mg Capsule 4s and Canditral 100mg Capsule 10s. Apart from Glenmark, some popular brands of Itraconazole capsules include Sun Pharma's I Win 100mg Capsule 7s, Alcros 100mg Capsule 7s, Lupin's Itrazole 100mg Capsule 4s, Cipla's Itranox 100 Mg Capsule 4s, Itralase 100 Mg Capsule 15s, etc.
At the latest SEC meeting for Antimicrobial & Antivirals held on 27.07.2021, the committee thoroughly examined the bioequivalence (BE) study report of Itraconazole Capsules 130mg presented by drug-maker Glenmark.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and marketing of Itraconazole Capsules 130mg indicated for the treatment of the following fungal infections in immunecompromised and nonimmunocompromised adult patients:
• Blastomycosis, pulmonary and extrapulmonary
• Histoplasmosis, including chronic cavitary pulmonary disease and disseminated nonmeningeal histoplasmosis,
• Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant to Amphotericin B therapy.