Ivermectin, Indian WHO-GMP supply for scabies, strongyloidiasis and neglected-tropical-disease programmes.
A broad-spectrum antiparasitic in the avermectin family and a WHO Essential Medicine (eEML medicine 58, first listed in 1987), ivermectin anchors neglected-tropical-disease and outbreak procurement. 3mg, 6mg and 12mg oral tablets from Indian WHO-GMP facilities with a product-specific CoPP and CTD dossier. We are honest about two limits up front: Indian-sourced ivermectin is not WHO-prequalified, and the free Mectizan donation covers onchocerciasis and lymphatic filariasis, so our commercial supply is for the non-donation channels (scabies, strongyloidiasis and general antiparasitic use).
Multiple WHO-GMP partner lines · 3mg / 6mg / 12mg oral tablets · WHO Essential Medicine (eEML 58) · NTD and outbreak procurement · CoPP and CTD dossier on file.
Active ingredient
Ivermectin, a broad-spectrum avermectin (macrocyclic lactone) antiparasitic from Streptomyces avermitilis. It binds glutamate-gated chloride channels in invertebrate nerve and muscle, paralysing and killing the parasite. Mammals are relatively protected because these channels are confined to the invertebrate nervous system, and the blood-brain barrier with P-glycoprotein efflux limits central-nervous-system penetration in mammals.
Strengths stocked
Oral tablets in 3mg (the WHO Essential Medicines form, scored), 6mg and 12mg strengths; the available strengths vary by manufacturer, and 12mg is a common Indian presentation, so we confirm the strength per current supplier before quoting. Human oral tablet only; topical ivermectin 1% cream and 0.5% lotion are separate finished products, and veterinary ivermectin is a distinct regulated product class we do not blend with human supply.
Indications
FDA on-label for strongyloidiasis and onchocerciasis; used and WHO-referenced for lymphatic filariasis (with albendazole, and the 2017 IDA triple therapy where onchocerciasis is not endemic), scabies including crusted scabies, cutaneous larva migrans, head lice, and soil-transmitted helminths (strong against Ascaris, weaker against hookworm and Trichuris). A WHO Essential Medicine. Typical single doses are around 200 mcg/kg for strongyloidiasis and scabies, and 150 mcg/kg for onchocerciasis.
Storage
Tablets carry a controlled-room-temperature storage instruction set by the approved product label (US-labelled tablets state 20 to 25C with excursions permitted to 15 to 30C; some products state store below 30C). The exact storage statement is taken from the manufacturer's approved labelling for the specific consignment. Ambient dispatch, no cold-chain required.
Shelf life
Product- and label-specific; taken from the approved product label and CoA for the consignment. Minimum 24 months remaining at dispatch on tablets, or we do not ship it.
Pack format
Tablets in blister or bottle, hospital, retail and MDA-programme packs. Outer carton and leaflet in the destination-regulator language, carrying the Loa loa co-infection caution and the Mazzotti-reaction note. Alu-Alu blister preferred for tropical destinations.
Neglected-tropical-disease and outbreak procurement, public-sector programmes and hospital supply, honestly bounded.
India is our origin. We do not sell into the Indian market. Ivermectin is exported only.
NTD and mass-drug-administration commercial channels
Ivermectin is a core neglected-tropical-disease medicine, but supply channels split. The free Mectizan Donation Program (Merck) covers onchocerciasis and lymphatic filariasis, so commercial and tendered procurement is more relevant for scabies control, strongyloidiasis and general soil-transmitted-helminth and antiparasitic supply. We quote the non-donation channels and do not imply we can supply into Mectizan-donated oncho or LF programmes, since that donated supply comes from Merck, not commercial sources.
Scabies control and outbreak response
WHO added scabies to its neglected-tropical-disease list in 2017, and single-dose oral ivermectin mass drug administration has shown efficacy for scabies control. Scabies-outbreak response and endemic control are a genuine commercial demand channel we supply, in tablet form, to ministries, institutions and NGO programmes, though formal global control guidelines are still developing.
Strongyloidiasis programmes
In August 2024 WHO issued its first guideline on public-health control of human strongyloidiasis, conditionally recommending mass drug administration with single-dose ivermectin (200 mcg/kg) for age five and older where prevalence is 5% or higher; strongyloidiasis affects an estimated 300 to 600 million people. This is a newly expanding, largely commercial procurement channel we are positioned to supply.
Public-sector and hospital supply
Ministry-of-health, hospital and NGO tenders across sub-Saharan Africa and South and Southeast Asia for the parasitic and ectoparasitic indications, plus private-sector and retail supply. Because no Indian ivermectin currently holds WHO prequalification, we compete on WHO-GMP plus product-specific CoPP and national registration, on the open commercial and ministry tenders that accept those credentials.
The Loa loa encephalopathy safeguard, the Mazzotti reaction, and honest limits on WHO-PQ and the Mectizan donation.
Typical dosing is a single oral dose of about 200 mcg/kg for strongyloidiasis and most soil-transmitted and ectoparasitic indications (scabies is commonly repeated after one to two weeks, a guideline-based off-label use), and about 150 mcg/kg for onchocerciasis, repeated every six to twelve months; crusted scabies uses an intensified multi-dose regimen combined with a topical scabicide, with schedules that vary between guidelines. Tablets are taken on an empty stomach with water; peak plasma concentration is at about four hours, the plasma half-life is about 18 hours, and the drug is metabolised by hepatic CYP3A4 and excreted almost entirely in faeces. The critical serious-safety flag is Loa loa co-infection. Ivermectin can cause serious, occasionally fatal neurological reactions, including encephalopathy, in patients co-infected with Loa loa who carry very high Loa loa microfilarial loads, a risk concentrated in loiasis-endemic Central Africa; before treating anyone with West or Central African exposure, patients should be assessed for loiasis, and mass drug administration in these areas must follow WHO and programme safeguards such as test-and-not-treat approaches. This is a clinical-use safeguard: a merchant-exporter supplies the finished product and does not direct clinical use, but the caution is set on our labelling. In onchocerciasis, the common early reaction is the Mazzotti reaction, an allergic and inflammatory response to dying microfilariae in the first few days (labelled rates include pruritus around 27.5%, rash 22.7%, fever 22.6%, arthralgia 9.3% and inguinal lymph-node enlargement 12.6%). Oral ivermectin is otherwise generally well tolerated, and most adverse effects in onchocerciasis reflect the host inflammatory response to dying parasites rather than direct drug toxicity. Two honest commercial limits belong here too: Indian-sourced ivermectin is not WHO-prequalified (the prequalified products are made outside India), so WHO or UN-linked tenders that mandate prequalified product are generally not open to it, and the Mectizan donation covers onchocerciasis and lymphatic filariasis, so we supply the non-donation channels rather than those programmes.
The documentation pack a regulator actually asks for.
Ivermectin is a WHO Essential Medicine and a core neglected-tropical-disease molecule. Our role is on the supply side, between the Indian WHO-GMP facility and your programme, regulatory or procurement team. We are explicit about two limits: we do not claim WHO prequalification for Indian-sourced ivermectin, and we do not imply supply into Mectizan-donated onchocerciasis or lymphatic-filariasis programmes.
CTD Module 3
Full chemistry, manufacturing and controls section in eCTD-ready format where the importing authority accepts it, with the Module 2 quality overall summary, prepared for the 3mg, 6mg and 12mg tablet strengths.
CoA and MoA, per batch
HPLC assay, related substances per Ph.Eur./USP, uniformity of dosage units, dissolution profile and microbial limits, signed by the manufacturer's authorised QC head, so the human-use tablet is documented distinctly from any veterinary product.
CoPP, WHO-GMP, MFG licence
A product-specific Certificate of Pharmaceutical Product in WHO format, issued per strength by CDSCO (applications route through the ONDLS digital portal, mandatory since 15 July 2025; a CoPP is typically valid for two years), with the WHO-GMP certificate and manufacturing licence.
The WHO-PQ position, stated plainly
No Indian ivermectin currently holds WHO prequalification (the prequalified 3mg tablets are made outside India). We do not claim WHO-PQ. Where a tender mandates a WHO-prequalified product, Indian-sourced ivermectin is generally not eligible unless an alternative quality-acceptance route applies; otherwise we compete on WHO-GMP, a product-specific CoPP and national registration. We tell buyers this constraint up front.
Temperature and stability
Ambient dispatch per the approved-label storage statement. For hot and humid markets we confirm Zone IVb (30C/75% RH) long-term stability data, the WHO and ICH condition for these destinations, verified per product and batch rather than asserted generically.
Pharmacovigilance
A named PV contact organised in the destination market against registration, with Periodic Safety Update Reports to ICH E2C. The Loa loa neurological-reaction risk and the Mazzotti reaction are the priority watch items.
Antiparasitic, anti-infective and ectoparasitic cluster.
Ivermectin sits in the neglected-tropical-disease and antiparasitic corner of the anti-infective range, alongside the tetracyclines used for rickettsial and vector-borne illness and the topical scabicides.
Doxycycline
Tetracycline for rickettsial and tick-borne illness, Lyme, malaria prophylaxis and cholera. WHO AWaRe Access.
Azithromycin
Macrolide for atypical CAP and trachoma mass drug administration. AWaRe Watch.
Dermatology →
Scabies, acne and skin lines, where topical ivermectin and permethrin sit.
Ceftriaxone
Third-generation cephalosporin for severe infection. 1g / 2g vials. AWaRe Watch.
All anti-infectives →
180+ SKUs across the antibacterial, antifungal and antiparasitic range.
Oncology →
High-value oncology and supportive-care portfolio.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (3mg / 6mg / 12mg tablet), pack, volume, destination, and channel: scabies control or outbreak response, strongyloidiasis programme, soil-transmitted-helminth or general antiparasitic supply, ministry or NGO tender. Note that we supply the non-donation channels, not Mectizan-donated onchocerciasis or lymphatic-filariasis programmes.
- We route to the right line. Multiple WHO-GMP human-use ivermectin lines are on the M Care roster; we confirm the strength per current supplier, the packaging suited to your climate zone, and that the human tablet is documented distinctly from any veterinary product.
- Commercial and regulatory offer. FOB / CIF price, lead time, CoPP and CTD dossier status per destination, and an honest read on WHO-PQ eligibility for the tender. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient dispatch with moisture and light protection, in-transit logging, on-arrival inspection.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life. Pharmacovigilance contact opened on registration; the Loa loa neurological risk and the Mazzotti reaction are the watch items.
Ivermectin supply, the specific questions.
What strengths of ivermectin do you supply, and is it the human or veterinary product?
We supply the human-use oral tablet in 3mg (the WHO Essential Medicines form), 6mg and 12mg strengths; available strengths vary by manufacturer and 12mg is a common Indian presentation, so we confirm per current supplier. Veterinary ivermectin is a separate, distinctly regulated product class, and we never blend it with human supply. Topical ivermectin 1% cream (rosacea) and 0.5% lotion (head lice) are separate finished products we can also source.
Is your ivermectin WHO prequalified?
No, and this is important to state plainly. No Indian-manufactured ivermectin currently holds WHO prequalification; the prequalified 3mg tablets are made outside India. We do not claim WHO-PQ. Where a WHO or UN-linked tender mandates a prequalified product, Indian-sourced ivermectin is generally not eligible unless an alternative quality-acceptance route applies. On the many open commercial and ministry tenders that accept WHO-GMP plus a product-specific CoPP and national registration, we compete on those credentials.
Can you supply into onchocerciasis or lymphatic-filariasis MDA programmes?
Not through commercial channels, and we will not imply otherwise. Onchocerciasis and lymphatic filariasis are covered by the free Mectizan Donation Program (Merck), which supplies those elimination programmes directly, not through merchant exporters. Our commercial supply is for the non-donation channels: scabies control, strongyloidiasis, other soil-transmitted-helminth and parasitic indications, and private, hospital and general-market supply.
How is the Loa loa safety risk handled?
It is the critical serious-safety flag and it is set on our labelling. Ivermectin can cause serious, occasionally fatal neurological reactions, including encephalopathy, in patients heavily co-infected with Loa loa, a risk concentrated in loiasis-endemic Central Africa. Before treating anyone with West or Central African exposure, patients should be assessed for loiasis, and mass drug administration in these areas must follow WHO and programme safeguards such as test-and-not-treat. This is a clinical-use safeguard; we supply the finished product and carry the caution on the pack, and the clinical decision belongs to the treating programme or clinician.
What are the main indications and doses you see in tenders?
Single-dose 200 mcg/kg for strongyloidiasis and scabies (scabies commonly repeated after one to two weeks), and 150 mcg/kg for onchocerciasis repeated every six to twelve months; crusted scabies uses an intensified multi-dose regimen with a topical scabicide. Ivermectin has strong activity against Ascaris and is used for other soil-transmitted helminths, though its activity against hookworm and Trichuris is comparatively weaker. Doses are the treating programme's decision; we supply the product and documentation.
Do you provide CTD dossiers and Zone IVb stability data?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement for the relevant ministries and regulators (NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, the GCC regulators and comparable bodies). For hot and humid destinations we confirm Zone IVb (30C/75% relative humidity) long-term stability data, verified per product and batch, and specify Alu-Alu blister or moisture-protective packaging.
Send the specifics. You'll have a price inside one working day.
Strength (3mg / 6mg / 12mg tablet), pack, volume, destination, and channel: scabies control or outbreak response, strongyloidiasis programme, soil-transmitted-helminth or general antiparasitic supply, ministry or NGO tender. We supply the non-donation channels, are honest about WHO-PQ eligibility, and never blend veterinary product. That is the enquiry. Everything else is on us.