Itraconazole Capsule Manufacturer in India

About

About Itraconazole Capsules — 9M India

9M India manufactures Itraconazole hard gelatin capsules — pellet-filled — at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Itraconazole is a broad-spectrum triazole antifungal with activity against dermatophytes, yeasts, dimorphic fungi and several mould species. The pellet-filled capsule formulation ensures superior bioavailability compared to conventional powder-filled capsules. Our 100mg capsules conform to BP/USP pharmacopoeial standards with complete stability data and regulatory documentation.

Capsule formulation specifications

Specification	Details
Molecule	Itraconazole
Dosage Form	Hard Gelatin Capsule — Pellet-filled
Available Strengths	100mg
Pharmacopoeial Standard	BP / USP
Therapeutic Class	Antifungal — Azole (Triazole)
Pack Options	4 capsules / 7 capsules / 14 capsules per strip; bulk packs available
Storage	Store below 25°C, protect from light and moisture
Shelf Life	24 months
MOQ	As per enquiry — contact us

Therapeutic use & clinical indications

Itraconazole inhibits fungal cytochrome P450-dependent lanosterol 14-alpha-demethylase, impairing ergosterol biosynthesis. The pellet-filled capsule formulation provides improved and more consistent bioavailability. It has a broader spectrum than fluconazole, covering dermatophytes, Aspergillus and dimorphic fungi.

Primary Indications:

Dermatomycoses — tinea pedis, tinea corporis, tinea cruris
Onychomycosis — nail fungal infections
Pityriasis versicolor
Oral and oesophageal candidiasis
Systemic mycoses — aspergillosis, histoplasmosis, blastomycosis
Fungal prophylaxis in neutropenic patients

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Export Markets & Regulatory

Export markets & regulatory readiness

9M India exports Itraconazole capsules to regulated and semi-regulated markets across the Middle East, Africa, CIS countries and ASEAN. All formulations are manufactured under WHO-GMP conditions and supported by complete regulatory documentation including CTD/ACTD dossiers, Certificate of Pharmaceutical Product (CoPP), Free Sale Certificate (FSC), and Certificate of Analysis (CoA).

WHO-GMP Certificate
DCGI Manufacturing Licence
Certificate of Pharmaceutical Product (CoPP)
Certificate of Analysis (CoA) — batch-wise
CTD / ACTD Dossier — on request
Stability Data — ICH Zone IVb (30°C/75% RH)

Partner with 9M India for Itraconazole capsule supply

Whether you are a pharmaceutical distributor, institutional buyer, government procurement agency or export partner, 9M India is equipped to supply Itraconazole capsules at scale — with full regulatory support and flexible packaging options.

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WHO-GMP
Certified
Export
Ready
15+ Countries
Supplied
DCGI
Approved

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We keep answer short

Frequently asked questions — Itraconazole capsules

01

Yes. 9M India manufactures Itraconazole 100mg hard gelatin capsules in pellet-filled format at its WHO-GMP certified facility. The pellet-filled design provides superior and more consistent bioavailability compared to conventional powder-filled capsules — a clinically important distinction for this molecule
02

Itraconazole has poor and variable oral bioavailability in powder form. The pellet-filled capsule formulation significantly improves dissolution and absorption, particularly when taken with food. This translates to more predictable clinical outcomes and is the preferred pharmaceutical form recommended in most treatment guidelines.
03

Itraconazole capsules manufactured by 9M India have a 24-month shelf life when stored below 25°C, protected from light and moisture. The lower storage temperature requirement compared to some other capsules is important for cold-chain planning in tropical markets.
04

9M India currently manufactures Itraconazole pellet-filled hard gelatin capsules in 100mg strength — the standard dose for most therapeutic indications including onychomycosis, dermatomycoses and systemic fungal infections.
05

Yes. Itraconazole 100mg capsules are used in both continuous therapy and pulse therapy protocols for onychomycosis (nail fungal infections). 9M India's formulation is suitable for both protocols and is supplied with full CoA and stability documentation.
06

Yes. Itraconazole capsules are part of 9M India's active export portfolio for the Middle East, Africa and ASEAN markets. Complete WHO-GMP documentation, CoPP and dossier support are available for market registration in these regions.