Dolutegravir, Indian WHO-Prequalified supply for Global Fund, PEPFAR and country HIV ART programmes.
The WHO-preferred first-line HIV antiretroviral since 2018, supplied as 50 mg adult INSTI, as the TLD fixed-dose backbone (TDF + 3TC + DTG 300/300/50) for the highest-volume regimen in global HIV procurement, and as paediatric dispersible 5 mg for infants and children at or above 4 weeks and 3 kg per WHO 2020 weight-band dosing. The generic equivalent of Tivicay, supplied under Medicines Patent Pool voluntary licences from Indian WHO-GMP-certified manufacturers, lawful into 90+ low- and middle-income countries. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-Prequalified partner lines · adult 50 mg + TLD 300/300/50 + paediatric dispersible 5 mg · MPP voluntary licence · CTD dossier on file · exporter, not manufacturer.
Active ingredient
Dolutegravir (as the sodium salt), a second-generation HIV-1 integrase strand transfer inhibitor with a high barrier to resistance, blocking proviral DNA integration into the host genome at the strand-transfer step. Supplied from Indian WHO-GMP-certified manufacturers under Medicines Patent Pool voluntary licence; M Care does not manufacture.
Strengths stocked
Adult 50 mg film-coated tablet once daily (standard INSTI dose), TLD fixed-dose 300/300/50 mg (TDF + 3TC + DTG, the single most-procured HIV regimen globally), paediatric dispersible 5 mg per WHO 2020 weight-band dosing for infants and children at or above 4 weeks and 3 kg, plus lower 10 mg and 25 mg tablets for paediatric escalation steps.
Indications
HIV-1 ART first-line preferred (WHO 2018 onward) for adults, adolescents and infants/children at or above 4 weeks and 3 kg; HIV-1 second-line in patients without INSTI-class resistance; treatment-experienced HIV-1 with full virologic suppression maintained. The single largest-volume antiretroviral regimen in Global Fund and PEPFAR procurement is TLD with dolutegravir as the INSTI partner.
Monitoring & counselling
Weight gain is real, especially in combination with TDF/3TC; counsel on lifestyle, monitor weight and metabolic parameters. Cation chelation with antacids, calcium, iron and multivitamins: separate dosing by 2 hours before or 6 hours after dolutegravir. Neuro-psychiatric signal: insomnia, abnormal dreams, depression. Pregnancy: WHO-preferred since the 2022 Tsepamo update resolved the historical neural tube defect concern.
Storage and pack
Store below 30°C in the original pack. Adult: HDPE bottle 30 or 90 tablets, or Alu-Alu blister for TLD. Paediatric: child-resistant HDPE bottle, scored dispersible. Bulk-pharma 1000-tablet packs for institutional tender. Shelf life typically 24-36 months, minimum 18 months at dispatch. Standard ambient dispatch lane, no cold-chain.
Licensing & lawful supply
Medicines Patent Pool voluntary licence from ViiV Healthcare covers 90+ low- and middle-income countries (most of sub-Saharan Africa, Asia, Latin America). We supply only where the MPP licence permits; we will not supply into the United States, United Kingdom, EU, Australia, Canada or Japan where the originator patent remains. The licence list is the operative authority on every quote.
Global Fund pooled procurement, PEPFAR, country HIV programmes, paediatric ART scale-up, across MPP-licensed territories.
India is our origin. We do not sell into the Indian market. Dolutegravir is exported only, and only where the Medicines Patent Pool licence permits supply.
Global Fund PPM + PEPFAR
Global Fund Pooled Procurement Mechanism (PPM) is the world's largest HIV ART buyer, sourcing almost exclusively from WHO-Prequalified Indian generic manufacturers across sub-Saharan Africa, Asia and Latin America. PEPFAR buys directly through SCMS and country-level USAID missions. Both source TLD and adult dolutegravir 50 mg as the WHO-recommended first-line backbone. M Care holds WHO PQ-listed lines for PPM and PEPFAR tender qualification; engagement is via the PPM e-tender platform and PEPFAR SCMS direct procurement. NGO procurement →
African country-level HIV programmes
NACA Nigeria, NASCOP Kenya, South Africa NDOH national ART (the world's single largest country HIV programme), TMDA Tanzania, NDA Uganda, EFDA Ethiopia, ZNPS Zambia, CMAM Mozambique. All run on TLD plus paediatric dispersible dolutegravir at scale, all require WHO PQ and country-level registration. We hold both, with active country-specific dossiers across the major African markets. See Nigeria, Kenya, South Africa for the country-specific procurement mechanics.
Paediatric ART scale-up (UNICEF, CHAI, MSF)
Paediatric dispersible 5 mg dolutegravir is the WHO-preferred ART for infants and children at or above 4 weeks and 3 kg per the 2020 weight-band dosing tables. UNICEF Supply Division procurement, CHAI paediatric ART scale-up partnerships, MSF country programmes and national paediatric ART programmes (Nigeria, South Africa, Kenya, Uganda, Malawi, Zimbabwe) all draw on the same WHO-PQ source pool. Pack labelling supports the 5-mL dispersible administration protocol.
LATAM and ASEAN MPP territories
Brazil (ANVISA) under the public-sector ART programme, Mexico (COFEPRIS) and other LATAM ministries; Philippines (FDA), Vietnam (DAV), Indonesia (BPOM), Cambodia, Myanmar through licensed importers and country HIV programmes. All covered by the Medicines Patent Pool licence list. M Care does not supply into the United States, United Kingdom, EU, Australia, Canada or Japan where the ViiV originator patent remains in force.
Weight gain, cation chelation, neuro-psychiatric counselling, pregnancy clearance and the high barrier to resistance.
Dolutegravir is once-daily 50 mg in adults, taken with or without food, and is the integrase backbone of TLD (TDF 300 mg + 3TC 300 mg + DTG 50 mg) which is the single most-procured HIV regimen globally. The high barrier to genetic resistance distinguishes it from first-generation INSTIs like raltegravir and elvitegravir, supporting once-daily fixed-dose use in resource-constrained settings where adherence support is variable. Cation chelation is the most important interaction at dispensing: divalent cations from antacids, calcium supplements, iron, multivitamins and sucralfate bind dolutegravir in the gut and reduce absorption, so dose dolutegravir 2 hours before or 6 hours after the cation source. Weight gain, especially in combination with TDF/3TC TLD, is a recognised metabolic signal that requires lifestyle counselling and ongoing weight, lipid and glucose monitoring; the magnitude is typically 3-7 kg over the first 96 weeks. Neuro-psychiatric effects (insomnia, abnormal dreams, depression, occasional suicidality) occur in a small subset of patients and warrant routine pre-treatment screening and an open clinical follow-up question on subsequent visits. Pregnancy and women of childbearing potential: the historical Tsepamo neural tube defect signal (2018) was formally resolved by WHO in July 2022 after the surveillance dataset reached over 9,000 dolutegravir-exposed pregnancies showing no increased NTD risk, and dolutegravir is now WHO-preferred across all populations including conception and pregnancy with no folic acid supplementation differential beyond standard antenatal care. UGT1A1 and CYP3A4 metabolism means rifampicin (TB co-treatment) requires dolutegravir dose-doubling to 50 mg twice daily; common SSRIs and proton-pump inhibitors are dosing-friendly. The destination-language SmPC carries the full table for the receiving HIV clinic and pharmacy team.
The documentation pack a regulator actually asks for.
Dolutegravir is supplied from Indian WHO-Prequalified facilities under Medicines Patent Pool voluntary licence. Our role is manufacturer-facing, we sit between the WHO-PQ plant and your procurement, regulatory or programme team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls in eCTD-ready format. Module 2 quality overall summary included. Polymorph control documented for the sodium salt, finished-product specifications, validation data, stability under ICH Zone IVb (30°C / 75% RH for 12 months minimum).
Bioequivalence
Comparative bioequivalence study reports against Tivicay reference product for the adult 50 mg, against the originator paediatric dispersible reference for the 5 mg formulation, and proportional-formulation justification for TLD.
CoA + WHO-PQ certificate per batch
HPLC assay, related substances per Ph.Eur./USP, water content by Karl Fischer, dissolution profile, content uniformity, hardness, friability. WHO Prequalification certificate in the shipping pack for Global Fund and PEPFAR reconciliation.
MPP licence reference
Medicines Patent Pool voluntary licence reference for the destination country, confirming lawful supply under the ViiV-MPP agreement. We verify the destination is on the MPP territory list before quoting, the licence reference travels with the shipping documentation.
CoPP, GMP, MFG licence
Issued by CDSCO (India), apostilled where required, notarised copies in the shipping pack. M Care does not hold US FDA, MHRA or EMA registration for this molecule; we do not supply into those markets under the MPP framework.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C, ADR reporting per local regulator. Weight gain, neuro-psychiatric events, hypersensitivity, hepatotoxicity in HBV co-infected patients are the priority signals.
The HIV ART backbone, OI prophylaxis and HBV co-treatment shelf.
Dolutegravir sits inside the TLD regimen and travels alongside the OI-prophylaxis and HBV-co-treatment products that ship on the same tenders.
Tenofovir + Emtricitabine
NtRTI + NRTI backbone. TDF/FTC for HIV ART (paired with DTG as second-line option) and standalone PrEP. WHO-PQ. Truvada generic.
All antivirals →
HIV ART, antimalarials, antivirals for chronic HBV and HCV, herpes-family antivirals, broader catalogue.
WHO-GMP & PQ compliance
How we route an order to the right WHO-PQ-listed line for Global Fund or PEPFAR award qualification.
Dossier preparation
Full CTD / eCTD dossier preparation for country-level HIV programme registration, MPP licence-coverage verification per destination.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (adult 50 mg / TLD 300/300/50 / paediatric dispersible 5 mg), tablet volume, destination, channel (Global Fund PPM / PEPFAR / country HIV programme / NGO / paediatric scale-up), and target delivery window.
- We verify MPP licence coverage and route. We confirm the destination is on the Medicines Patent Pool territory list and route to the right WHO-PQ-listed line; we will not quote into a market where the MPP licence does not permit supply.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status, WHO PQ certificate reference, MPP licence reference, full documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch (no cold-chain), in-transit logging and on-arrival inspection. Typical 60-120 days for Global Fund PPM tender award delivery, 8-12 weeks for made-to-order batches.
- After delivery. Batch records, CoA, stability data and WHO-PQ certificate archived for the full shelf life. PV contact opened on registration, ADR routing established.
Dolutegravir and TLD supply, the specific questions.
What strengths and pack formats of dolutegravir do you supply?
Adult 50 mg film-coated tablet once daily (the standard INSTI dose), TLD fixed-dose combination 300 mg TDF + 300 mg 3TC + 50 mg DTG once daily (the highest-volume regimen in Global Fund and PEPFAR procurement), paediatric dispersible 5 mg tablet (scored, per WHO 2020 weight-band dosing for infants and children at or above 4 weeks and 3 kg), and lower-strength 10 mg and 25 mg tablets where required for paediatric escalation. Pack formats: HDPE bottle 30 or 90 tablets for adult, Alu-Alu blister for TLD, and child-resistant HDPE for paediatric dispersible. Bulk-pharma 1000-tablet packs for institutional tender.
Is your dolutegravir WHO Prequalified for Global Fund and PEPFAR procurement?
Yes. Multiple M Care partner facilities hold active WHO Prequalification for adult dolutegravir 50 mg, TLD 300/300/50 fixed-dose and paediatric dispersible 5 mg. WHO PQ is the gating regulatory ticket for the Global Fund Pooled Procurement Mechanism (PPM), PEPFAR Supply Chain Management System (SCMS) direct procurement, and the major African country-level HIV programmes (NACA Nigeria, NASCOP Kenya, South Africa NDOH national ART, TMDA Tanzania, EFDA Ethiopia, NDA Uganda, ZNPS Zambia, CMAM Mozambique). We engage on the PPM e-tender platform and through PEPFAR SCMS against this status.
Is this the generic equivalent of Tivicay? What about patents?
Yes. We supply generic dolutegravir, the molecule sold under the originator brand Tivicay (ViiV Healthcare, marketed by GSK). Indian generic supply operates under voluntary licences granted by ViiV through the Medicines Patent Pool (MPP) covering 90+ low- and middle-income countries, primarily across sub-Saharan Africa, Asia and Latin America. Lawful supply is well-established into the MPP-covered LMIC list. The originator patent remains in higher-income markets (US, UK, EU, Australia, Canada, Japan) and we will not supply into those markets. The MPP licence list is the operative authority and we verify each destination against it before quoting.
Can you supply dolutegravir for paediatric HIV programmes?
Yes. Paediatric dispersible 5 mg dolutegravir is supplied per WHO 2020 weight-band dosing for infants and children at or above 4 weeks of age and 3 kg of weight, dispersed in 5 mL of water for administration. WHO PQ is active for the dispersible formulation across multiple Indian generics. The paediatric LIQ (lamivudine + dolutegravir) and PAD (paediatric ART dispersible) combinations are also available where the destination programme uses combined formulations. UNICEF Supply Division procurement, CHAI paediatric scale-up programmes, and country-level paediatric ART tenders are all served.
What is the historical neural tube defect signal status?
The Tsepamo birth-outcomes surveillance study in Botswana initially (2018) suggested a potential increased risk of neural tube defects (NTDs) with dolutegravir exposure at conception. The signal triggered cautious WHO guidance during 2018-2019. By 2022 the Tsepamo dataset had grown to over 9,000 dolutegravir-exposed pregnancies and the NTD prevalence was no longer significantly different from other ART regimens. WHO formally removed the precautionary restriction in July 2022. Dolutegravir is now WHO-preferred ART across all populations including women of childbearing potential and pregnancy, with standard counselling on weight gain, neuro-psychiatric effects and cation interactions.
Which markets can you ship dolutegravir into?
All 90+ countries covered by the Medicines Patent Pool voluntary licence: Global Fund PPM + PEPFAR territories (sub-Saharan Africa, Asia, Latin America); country-level public-sector HIV programmes (NACA Nigeria, NASCOP Kenya, South Africa NDOH, TMDA Tanzania, NDA Uganda, EFDA Ethiopia, ZNPS Zambia, CMAM Mozambique, UNIFAR Brazil, PhilHealth Philippines); GCC private-sector hospitals through licensed local importers under verified patent position. We do NOT supply into the United States, United Kingdom, European Union, Australia, Canada or Japan where the originator patent remains. We do not supply into India. Full market coverage at markets.
What documentation is included with a dolutegravir consignment?
Batch-specific Certificate of Analysis (HPLC dolutegravir assay, related substances per Ph.Eur./USP, water content, dissolution profile, content uniformity, hardness, friability), Method of Analysis, bioequivalence study report against Tivicay reference, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate, Medicines Patent Pool licence reference, Certificate of Origin, destination-language pack insert with the weight-gain, neuro-psychiatric, cation-interaction and pregnancy-safety counselling text, and temperature/humidity logs from pre-dispatch through on-arrival. PV contact nominated on registration. See dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength (adult 50 mg / TLD 300/300/50 / paediatric dispersible 5 mg), tablet volume, destination, programme (Global Fund / PEPFAR / country HIV / NGO / paediatric scale-up), and target delivery. We verify MPP licence coverage as part of the quote. Everything else is on us.