What is Ivermectin?

Ivermectin is a medication used to treat parasitic infections. It refers to a class of drugs called antiparasitic agents. It acts by killing parasites within the body.

Ivermectin is used a lot on both people and animals. In humans, it treats river blindness, lymphatic filariasis, and scabies.

In animals, it regulates both internal and external parasites.

Ivermectin is available in tablet form, topical creams, and injections.

The tablet form is a convenient choice for many patients.

The drug’s accessibility and efficacy make it a popular therapeutic option worldwide.

Product Overview Table

Field	Details
Product Name	Ivermectin Tablets
INN / Generic Name	Ivermectin
Therapeutic Class	Antiparasitic / Anthelmintic Avermectin (macrocyclic lactone)
Mechanism (brief)	Binds glutamate-gated chloride channels in invertebrate nerve and muscle cells, causing parasite paralysis
Indications	Onchocerciasis, lymphatic filariasis (with albendazole), strongyloidiasis, soil-transmitted helminthiasis, scabies
API Quality	Manufactured using DMF-grade Ivermectin human pharmaceutical grade only
Pharmacopoeial Standard	USP (Ivermectin Tablets USP); IP on request; Ph. Int. specification for WHO/UN tender routes
Available Strengths	3 mg, 6 mg, 12 mg (9 mg )
Dosage Forms	Uncoated scored tablets; film-coated on request; dispersible tablets
BCS Classification	Class II low solubility, high permeability (biowaiver not available)
Shelf Life	24 – 36 Months
Storage	Store below 30°C, protected from light and moisture
Manufacturing Facility	WHO-GMP certified human oral solid dosage block no veterinary manufacturing on site
Dossier Available	Yes, CTD / ACTD / eCTD format
Regulatory Documents	CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, BE Study Report
Markets Served	Africa, Southeast Asia, LATAM, Pacific, Middle East

Product Variants, Dosage Forms & Strengths

Ivermectin Tablets 3 mg

The reference strength for weight-banded dosing and the presentation most widely used in mass drug administration and paediatric-eligible populations.

Because dosing is calculated per kilogram of body weight, the 3 mg tablet gives programme pharmacists the finest dosing granularity across weight bands, which is why it dominates NTD programme specifications.

Supplied as a scored white tablet to support accurate dispensing.

Ivermectin Tablets 6 mg

The mid-range strength, widely dispensed in private retail and clinic channels where a single adult course is filled without programme weight-banding.

Reduces tablet count per patient against the 3 mg presentation, which matters for both patient compliance and per-course packaging cost.

Strong private-market and pharmacy-channel demand across LATAM, the Middle East and South Asia

Ivermectin Tablets 12 mg

The high-strength presentation for adult patients in the upper weight bands and for indications requiring the full weight-adjusted dose in a minimum number of tablets.

Frequently specified where storage volume and dispensing time are constraints a meaningful factor in high-throughput outreach settings.

Preferred for adult treatment courses and campaign settings with high patient throughput

Ivermectin Dispersible Tablets

Disperses in water for patients unable to swallow whole tablets relevant to scabies programme settings

Note that current labelling restricts use below defined body weight thresholds; artwork must reflect this

Pharmacopoeial Compliance

USP (United States Pharmacopeia): Ivermectin Tablets USP is the standard specification for this molecule and the one referenced in WHO prequalification documentation

IP (Indian Pharmacopoeia): Available on request

Ph. Int. (International Pharmacopoeia): Relevant where WHO or UN agency procurement routes apply

Assay, dissolution, uniformity of dosage units and related substances are tested against the declared monograph.

Because ivermectin is poorly water soluble, the dissolution method uses a surfactant-containing medium;

the method and its validation are documented in full within the dossier, since dissolution is the rate-limiting step for absorption and is scrutinised closely by reviewers.

Regulatory & Dossier Support

Dossier Availability

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

ACTD (ASEAN Common Technical Dossier): Philippines, Vietnam, Myanmar, Indonesia, Cambodia

eCTD: for authorities mandating electronic submission

Module 3 quality documentation including process validation, blend and content uniformity, dissolution method validation and impurity profiling against the USP related substances specification

Stability data: real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with photostability data supporting the light-protection storage statement

Country-specific dossier customisation and regulatory query response support included

Bioequivalence: Why a Biowaiver Is Not Available for Ivermectin

Ivermectin is a BCS Class II molecule poorly water soluble but highly permeable with absorption governed largely by bile-micelle-mediated solubilisation in the gut.

BCS-based biowaivers are available only for Class I substances, so in-vivo bioequivalence (BE) data is required for market authorisation in essentially every jurisdiction.

Ivermectin also shows a pronounced positive food effect, which means BE study design must match the fed or fasted condition stated in the reference product labelling.

Our submissions carry BE study reports generated against the innovator comparator under the applicable condition.

BE study report available [CONFIRM which strengths are covered and which comparator was used]

Strength-to-strength biowaiver may be accepted for proportionally similar strengths where a BE study exists on one strength and dissolution profiles are comparable subject to the individual authority

Discriminatory dissolution method with surfactant medium documented and validated a routine query point for Class II molecules

Drug Master File (DMF)

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

API sourced against a qualified vendor with full impurity, residual solvent and B1a/B1b component ratio characterisation

CDSCO / Indian DMF reference accepted by a large number of importing authorities shortens query cycles

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

Human-use pharmaceutical manufacturing only no veterinary production on site, and no shared equipment with veterinary product lines.

This is documented in the SMF and is a standing question from serious buyers in this category.

Low-dose product controls: dedicated containment handling, blend and content uniformity data at batch level, and validated cleaning with swab recovery critical because a 3 mg tablet is a low-dose presentation where uniformity failures are the main quality risk

Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Philippines 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, plus photostability
BE Study Report	In-vivo bioequivalence against innovator comparator not waivable for this molecule
Dissolution Profile Report	Surfactant-medium method; the key performance parameter for a Class II drug
Content Uniformity Data	Batch-level essential assurance for a low-dose tablet
Human-Use Declaration	Confirms pharmaceutical grade and no veterinary manufacturing on site
Excipient Declarations	For all inactive ingredients used
Batch Manufacturing Records (BMR)	Available on request, NDA basis

WHO Prequalification & Donor-Funded Procurement

WHO Prequalification status: [TBC confirm whether held, under assessment, or not applicable]

Where PQ is not held, our supply route is direct MOH registration and commercial distribution, for which the full CTD dossier and CoPP package is supplied

Ivermectin Tablets USP is the specification referenced in WHO prequalification documentation for this molecule, and our product is manufactured to that same monograph

Programme buyers should note that a substantial share of onchocerciasis and lymphatic filariasis mass drug administration is served by donated product; commercial demand concentrates in scabies, strongyloidiasis, soil-transmitted helminthiasis and private retail channels

Clinical Indications & Therapeutic Information

Ivermectin is a broad-spectrum antiparasitic of the avermectin class.

It binds selectively to glutamate-gated chloride channels present in invertebrate nerve and muscle cells, increasing membrane permeability and causing paralysis and death of the parasite.

Ivermectin is included on the WHO Model List of Essential Medicines as a broad-spectrum antiparasitic, which keeps it inside national essential medicines lists and recurring public procurement cycles

WHO-recognised indications: onchocerciasis (river blindness); lymphatic filariasis, given with albendazole; intestinal non-disseminated strongyloidiasis; other soil-transmitted helminth infections in combination regimens; and severe or crusted scabies, including mild to moderate scabies where topical treatment is unsuitable

Dosing is weight-adjusted at approximately 200 micrograms per kilogram and is prescriber-guided; labelling carries body-weight and pregnancy restrictions that must be reflected in leaflet and carton artwork for each market

Scabies has driven a structural expansion in commercial demand over the past decade, particularly across the Pacific islands, remote Australia and parts of sub-Saharan Africa, where community-level treatment campaigns are increasingly standard practice

Market context worth flagging to buyers: moxidectin has been added to the WHO Essential Medicines Lists as a therapeutic alternative for river blindness and lymphatic filariasis, so long-range programme forecasts for those two indications should not be treated as fixed

Target Export Markets

Africa

Active markets: Nigeria, Ethiopia, Tanzania, Uganda, Ghana, Cameroon, Côte d’Ivoire, DR Congo, Sudan

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

Programme demand: onchocerciasis and lymphatic filariasis elimination remain concentrated here, alongside growing scabies and STH treatment volumes

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

Southeast Asia & Pacific

Active markets: Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Papua New Guinea, Solomon Islands, Fiji, Vanuatu

ACTD dossier format supplied as standard for ASEAN registrations

Pacific island markets carry disproportionately high scabies burden relative to population, and procure through both MOH and regional pooled mechanisms

Stability: ICH Zone IVb data plus Alu-Alu packing is effectively a prerequisite across this region

Latin America (LATAM)

Active markets: Colombia, Peru, Ecuador, Bolivia, Guatemala, Honduras, Brazil

USP pharmacopoeial standard preferred; Spanish and Portuguese labelling available

Strong private pharmacy channel demand for the 6 mg presentation alongside programme procurement

Middle East & South Asia

Active markets: Yemen, Iraq, Jordan, Bangladesh, Nepal, Sri Lanka

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

Arabic labelling available on request

Export Packaging & Supply Chain

Primary Packaging Options

Presentation	Packaging Options
Ivermectin 3 mg Tablets	Alu-Alu blister 4×1 and 10×10; programme packs 100/500 tablets in HDPE jars with desiccant
Ivermectin 6 mg Tablets	Alu-Alu blister 2×1, 4×1 and 10×10 with mono-carton and leaflet
Ivermectin 12 mg Tablets	Alu-Alu blister 1×1, 2×1 and 4×1 single-course retail configuration
MDA / Campaign Supply	Bulk shipper cartons with programme overprinting and dose-pole reference

Ivermectin tablets are light and moisture sensitive, so Alu-Alu is our default recommendation for African, ASEAN and Pacific destinations; PVC/PVDC is offered where landed cost is decisive, supported by pack-specific stability data so the choice rests on evidence rather than assumption.

Campaign and MDA supply typically favours larger counts per container to cut per-dose handling time at the point of distribution.

Labelling & Customisation

Private label manufacturing with your brand name, artwork and trade dress

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

Country-specific compliance built into artwork: NAFDAC number field, local registration number, batch/expiry format, storage statement and the body-weight and pregnancy restrictions carried in the reference labelling

Logistics & Supply

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

No cold chain required; protect from prolonged heat and light exposure in transit and storage

Experienced in campaign-linked delivery windows, where a late shipment does not delay a sale but collapses an entire treatment round programme timelines are confirmed in writing before order acceptance

Why Source Ivermectin Tablets From Us?

WHO-GMP Certified, Human-Use Only: Manufactured in a human pharmaceutical facility with no veterinary production or shared equipment on site. GMP certificate and Site Master File (SMF) shared on request.

In-Vivo Bioequivalence Data Held: Ivermectin cannot be registered on a biowaiver. We hold BE study reports against innovator comparator, which removes the single biggest cause of rejection for this molecule.

Complete Dossier for 100+ Countries: CTD, ACTD and eCTD dossiers pre-compiled, with regulatory query response support included.

Low-Dose Uniformity Control: Batch-level content uniformity and validated cleaning data for the 3 mg presentation, where uniformity is the principal quality risk and the first thing an auditor examines.

WHO Essential Medicine Molecule: Ivermectin’s WHO Model List of Essential Medicines status keeps it inside national EMLs and recurring NTD programme procurement.

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 Ivermectin Tablets FDF?

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

If you are evaluating for a tender or programme submission, request the dossier summary, BE study abstract and a sample CoA first no commitment required.