Fluconazole Capsule Manufacturer in India

About

About Fluconazole Capsules — 9M India

9M India manufactures Fluconazole hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Fluconazole is a triazole antifungal agent with potent activity against Candida species and Cryptococcus neoformans. It is an essential medicine listed by the WHO and is widely used across hospital and community settings for fungal infections. Our 150mg and 200mg capsules conform to BP/USP pharmacopoeial standards with complete export documentation and stability data.

Capsule formulation specifications

Specification	Details
Molecule	Fluconazole
Dosage Form	Hard Gelatin Capsule
Available Strengths	150mg, 200mg
Pharmacopoeial Standard	BP / USP / IP
Therapeutic Class	Antifungal — Azole (Triazole)
Pack Options	1 capsule / 7 capsules / 14 capsules per strip; bulk packs available
Storage	Store below 30°C, protect from moisture
Shelf Life	24 months
MOQ	As per enquiry — contact us

Therapeutic use & clinical indications

Fluconazole inhibits fungal cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase, disrupting ergosterol synthesis and fungal cell membrane integrity. It is fungistatic against most Candida species and fungicidal against Cryptococcus neoformans.

Primary Indications:

Vaginal candidiasis — single-dose 150mg treatment
Oropharyngeal and oesophageal candidiasis
Systemic candidiasis — invasive infections
Cryptococcal meningitis — treatment and prophylaxis
Dermatophytosis — tinea infections
Antifungal prophylaxis in immunocompromised patients

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Export markets & regulatory

Export markets & regulatory readiness

9M India exports Fluconazole capsules to regulated and semi-regulated markets across the Middle East, Africa, CIS countries, ASEAN and Latin America. 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 Fluconazole capsule supply

Whether you are a pharmaceutical distributor, institutional buyer, government procurement agency or export partner, 9M India is equipped to supply Fluconazole 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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Frequently asked questions — Fluconazole capsules

01

Yes. 9M India Limited manufactures Fluconazole hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. The formulation is DCGI approved and exported to markets across the Middle East, Africa, CIS and ASEAN.
02

9M India manufactures Fluconazole hard gelatin capsules in 150mg and 200mg strengths. The 150mg single-dose capsule is the standard for vaginal candidiasis treatment, while 200mg is used for systemic fungal infections and prophylaxis in immunocompromised patients.
03

Yes. Fluconazole is included in the WHO Model List of Essential Medicines. 9M India manufactures to WHO-GMP standards and can supply to WHO prequalification aligned programmes and institutional procurement agencies with appropriate documentation.
04

Fluconazole 150mg capsules are typically supplied in 1-capsule or 7-capsule strips depending on the indication. 200mg capsules are available in 7-capsule and 14-capsule strip formats. Custom packaging is available for institutional and bulk export orders.
05

Yes. 9M India can produce Fluconazole capsules with multilingual labelling — including Arabic, French, Russian and other languages — to meet destination market regulatory requirements. Please share labelling specifications with our export team.
06

For semi-regulated markets, 9M India provides the WHO-GMP Certificate, CoPP, CoA, site master file, manufacturing licence and product dossier. For regulated markets requiring full CTD submission, we provide complete CTD/ACTD dossiers on request.