Introduction

Actiza Pharmaceutical is a WHO-GMP-certified pharmaceutical exporter supplying Fluconazole Tablets as a finished dosage formulation, not an API, to importers, distributors, and institutional buyers across Africa, Southeast Asia, and Latin America.

Our range spans 50 mg, 100 mg, 150 mg, and 200 mg strengths, including the high-velocity 150 mg single-dose pack, formulated for rapid dissolution and consistent oral bioavailability.

Every strength ships with a complete CTD dossier, also available in ACTD and eCTD format, supported by bioequivalence documentation, CoPP, FSC, and ICH Zone IVb stability data so your regulatory team can proceed directly to MOH registration rather than chasing supplementary paperwork.

Moisture-protective Alu-Alu blistering is available as standard for hot and humid destinations.

Product Overview

Field	Details
Product Name	Fluconazole Tablets
INN / Generic Name	Fluconazole
Therapeutic Class	Triazole Antifungal Systemic
Mechanism	Inhibits fungal CYP51 (14-alpha-demethylase), disrupting ergosterol synthesis
Indications	Vaginal, oropharyngeal and oesophageal candidiasis; cryptococcal meningitis; dermatophytosis; antifungal prophylaxis
API Quality	Manufactured using DMF-grade Fluconazole (polymorph Form II / III)
Pharmacopoeial Standard	USP / IP for tablets; BP for capsule and suspension presentations
Available Strengths	50 mg, 100 mg, 150 mg, 200 mg
Dosage Forms	Uncoated and film-coated tablets; dispersible tablets; capsules; oral suspension
Shelf Life	36 Months from date of manufacture
Storage	Store below 30°C, protected from light and moisture
Manufacturing Facility	WHO-GMP certified general oral solid dosage block physically segregated from beta-lactam facilities
Dossier Available	Yes, CTD / ACTD / eCTD format
Regulatory Documents	CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, BE / Biowaiver Data
Markets Served	Africa, Southeast Asia, LATAM, Middle East, CIS

Product Variants, Dosage Forms & Strengths

Fluconazole Tablets 50 mg, 100 mg & 200 mg

The multi-dose strengths used for course therapy oropharyngeal and oesophageal candidiasis, dermatophyte infections, and the consolidation and maintenance phases of cryptococcal disease management.

Supplied as immediate-release tablets, uncoated or film-coated, with a rapid dissolution profile validated across pH 1.2, 4.5, and 6.8.

The 200 mg strength carries the highest institutional and tender volume, particularly in HIV-programme procurement.

Target buyers: MOH tenders, NGO health programmes, hospital supply chains, private distributors.

Fluconazole 150 mg Single-Dose Tablet

The single highest-velocity fluconazole presentation worldwide, dispensed as a one-tablet course for uncomplicated vaginal candidiasis.

Because it moves through retail and pharmacy channels rather than tenders, artwork quality, blister presentation, and shelf appeal matter as much as the specification and this is the SKU most frequently requested under private label.

Supplied in 1×1 and 4×1 Alu-Alu blisters with a mono-carton and leaflet.

Highest private label demand of any strength in the antifungal portfolio.

Fluconazole Dispersible Tablets

Disperses in water for paediatric and difficult-to-swallow patients preferred in tropical and low-resource markets.

BCS Class I biowaiver logic extends to the paediatric population where dissolution criteria are met.

Related Presentations Available From the Same Facility

Fluconazole Capsules 50 mg / 150 mg / 200 mg hard gelatin and HPMC (vegetarian) shells; BSE/TSE declaration provided for gelatin shells.

Fluconazole Oral Suspension 50 mg/5 ml paediatric presentation, tropical stability formulation.

Pharmacopoeial Compliance

USP (United States Pharmacopeia) Fluconazole Tablets USP; the reference standard for LATAM and most global tenders.

IP (Indian Pharmacopoeia) available on request. BP (British Pharmacopoeia) applicable to capsule and oral suspension presentations.

Dissolution, assay, uniformity of dosage units, and related substances are tested against the declared monograph, and comparative dissolution profiles at pH 1.2, 4.5, and 6.8 are held on file to support biowaiver submissions.

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document) ICH-aligned, for regulated and semi-regulated markets.

ACTD (ASEAN Common Technical Dossier) for Philippines, Vietnam, Myanmar, Indonesia, Cambodia. eCTD for authorities mandating electronic submission.

Module 3 quality documentation includes process validation, blend uniformity, dissolution method validation, and polymorphic form control for the API.

Stability data includes real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with moisture-uptake data supporting the recommended pack.

Country-specific dossier customisation and regulatory query response support included.

Bioequivalence & BCS-Based Biowaiver

Fluconazole is classified as a BCS Class I drug substance highly soluble and highly permeable, with a wide therapeutic index and oral bioavailability above 90%.

A published biowaiver monograph supports the substitution of in-vitro dissolution data for in vivo bioequivalence (BE) studies for immediate-release solid oral dosage forms, provided the API is present as polymorph Form II or III, excipients are limited to those used in approved IR fluconazole products in ICH countries, and both test and comparator products are rapidly or very rapidly dissolving with similar profiles at pH 1.2, 4.5, and 6.8. Our dossiers are built to meet all three conditions.

BE study data available for the 150 mg strength

BCS-based biowaiver route supported for remaining strengths through comparative dissolution profiles held throughout shelf life

Polymorphic form of the API is specified and controlled in the dossier a common gap in competitor submissions and a frequent source of authority queries

Drug Master File (DMF)

Drug Master File (DMF) reference for the Fluconazole API is available for cross-referencing in your registration dossier.

API is sourced against a qualified vendor with elemental impurity, residual solvent, and polymorph characterisation data.

CDSCO / Indian DMF reference is accepted by a large number of importing authorities shortening query cycles and registration timelines.

Manufacturing Compliance

WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis.

Site Master File (SMF) available for regulatory submissions.

Fluconazole is not a beta-lactam, so no penicillin block is required but manufacturing is physically segregated from any beta-lactam operations, with dedicated air handling and validated cleaning between products to eliminate cross-contamination risk.

Cleaning validation with swab and rinse recovery data available a standard question in African and ASEAN facility assessments.

Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Philippines, DRAP (Pakistan), and INVIMA (Colombia).

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms batch quality against the agreed specification
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most importing countries
Free Sale Certificate (FSC)	Confirms the product is freely sold in the country of manufacture
Method of Analysis (MOA)	Analytical methodology—mandatory dossier component
GMP Certificate	Confirms manufacturing site compliance
Stability Data	Real-time and accelerated—ICH Zone IVb for tropical markets
BE / Biowaiver Data Package	Comparative dissolution at pH 1.2, 4.5, 6.8 plus BE report where applicable
Dissolution Profile Report	Supports the biowaiver route and rapid-dissolution claim
BSE/TSE Declaration	Provided for hard gelatin capsule presentations only
Excipient Declarations	For all inactive ingredients, including colourant declarations where used
Batch Manufacturing Records (BMR)	Available on request, NDA basis

Clinical Indications & Therapeutic Information

Fluconazole is a broad-spectrum triazole antifungal active primarily against Candida and Cryptococcus species.

It works by inhibiting the fungal enzyme CYP51 (14-alpha-demethylase), which halts ergosterol synthesis and destabilises the fungal cell membrane.

Fluconazole is included on the WHO Model List of Essential Medicines listed as a 150 mg capsule, oral liquid, and injection, with most national EMLs carrying the tablet as the equivalent solid oral form. This listing keeps the molecule permanently inside public procurement cycles.

Principal indications: vaginal candidiasis, oropharyngeal and oesophageal candidiasis, systemic and disseminated candidiasis, and cryptococcal meningitis

Also used prophylactically to reduce fungal infection incidence in immunocompromised patients, including those undergoing chemotherapy or transplantation

Dose and duration vary substantially by indication, patient age and renal function, and are prescriber-guided; fluconazole has recognised CYP2C9 and CYP3A4 interaction potential that prescribers manage clinically

Demand across sub-Saharan Africa is structurally tied to HIV disease burden cryptococcal meningitis management makes fluconazole a recurring line item in national programme procurement rather than a discretionary purchase

The 150 mg single-dose presentation carries separate, high-volume retail demand that is largely independent of tender cycles giving distributors two distinct revenue streams from one molecule

Target Export Markets

Africa

Active markets: Nigeria, Kenya, Tanzania, Ghana, Uganda, Ethiopia, Zambia, Zimbabwe, Cameroon, Côte d’Ivoire.

Registration support: NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Ghana CoPP and FSC are the primary gatekeeping documents.

Programme demand: HIV-related antifungal procurement drives sustained 200 mg volumes across the region.

Labelling: English and French artwork available for Anglophone and Francophone Africa.

Southeast Asia

Active markets: Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh.

ACTD dossier format supplied as standard mandatory for ASEAN registrations.

Stability: ICH Zone IVb data plus Alu-Alu packing is effectively a prerequisite in this climate zone.

Latin America (LATAM)

Active markets: Colombia, Peru, Ecuador, Bolivia, Guatemala, Honduras, Dominican Republic.

USP pharmacopoeial standard preferred; Spanish-language labelling and inserts available.

CTD format with local regulatory adaptation, legalisation and apostille support.

Middle East & CIS

Active markets: Iraq, Yemen, Jordan, Uzbekistan, Kazakhstan, Kyrgyzstan, Azerbaijan.

GMP Certificate and CoPP are the primary registration requirements across these authorities.

Arabic and Russian labelling available on request.

Export Packaging & Supply Chain

Primary Packaging Options

Presentation	Packaging Options
Fluconazole 150 mg Tablet	Alu-Alu blister 1×1 and 4×1 with mono-carton and leaflet—the standard retail configuration
Fluconazole 50 / 100 / 200 mg Tablets	Alu-Alu blister 10×10, PVC/PVDC blister 10×10, 4×1 and 7×1 course packs
Institutional / Tender Supply	HDPE jars of 100 / 500 / 1000 tablets with induction seal and desiccant
Capsules	Alu-Alu blister 10×10; BSE/TSE declaration supplied for gelatin shells

Fluconazole tablets require reliable moisture protection over a 36-month shelf life in Zone IVb conditions.

Alu-Alu is recommended as the default for African, ASEAN and Gulf destinations; PVC/PVDC is offered where landed cost is the deciding factor, supported by pack-specific stability data so the choice is made on evidence rather than assumption.

Labelling & Customisation

Private label manufacturing with your brand name, artwork and trade dress highest uptake on the 150 mg SKU.

Multi-lingual labelling: English, French, Spanish, Portuguese, Arabic, Russian.

Country-specific compliance built into artwork: NAFDAC number field, local registration number, batch/expiry format, and mandated storage statement.

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement.

No cold chain required; containers should be protected from prolonged heat exposure and stowed away from hot bulkheads.

Documented export experience across Africa, CIS, LATAM, and Southeast Asia, including port-clearance documentation support.

Why Source Fluconazole Tablets From Us?

WHO-GMP Certified Manufacturing Audit-ready facility with segregated non-beta-lactam production, validated cleaning and full environmental controls.

GMP certificate and Site Master File (SMF) shared on request.

Complete Dossier for 100+ Countries CTD, ACTD and eCTD dossiers pre-compiled, with regulatory query response support included. Cuts weeks off your market authorisation timeline.

BCS Class I Biowaiver Advantage Bioequivalence data plus a compliant biowaiver dissolution package means fewer authority queries and a materially faster, lower-cost registration route.

WHO Essential Medicine Molecule Fluconazole’s WHO Model List of Essential Medicines status keeps it inside national EMLs and recurring government tenders, protecting your volume forecast.

Private Label & Custom Packaging MOQ-based private labelling with your brand name, multi-lingual artwork and country-specific regulatory text, with Alu-Alu as standard for tropical destinations.

End-to-End Regulatory Support From CoA to CoPP to FSC, all export documentation handled in-house by a dedicated regulatory team through to MOH registration.

Frequently Asked Questions

Ready to Source Fluconazole Tablets FDF?

Share your target market, required strengths and volume, and our export team will respond with the applicable pharmacopoeial specification, dossier format, pack options, and pricing.

If you are still evaluating, request the dossier summary and a sample CoA first no commitment required.