Tenofovir + Emtricitabine — Indian WHO-GMP supply for Global Fund HIV ART, PrEP and HBV programmes.
The single most-prescribed HIV antiretroviral backbone globally. WHO-recommended first-line as TDF/FTC + dolutegravir (TLD), plus daily oral PrEP for HIV-negative adults at substantial risk, plus HBV co-treatment. Supplied from Indian WHO-GMP facilities holding active WHO Prequalification for Global Fund, PEPFAR, NACA Nigeria, NASCOP Kenya, South Africa national ART tender, and Africa CDC HIV programmes.
Multiple WHO-GMP partner lines · Adult 300/200mg + paediatric weight-band tablets · CTD dossier on file · WHO PQ active for Global Fund + PEPFAR.
Active ingredients
Tenofovir disoproxil fumarate (TDF), an oral prodrug of tenofovir, a nucleotide reverse transcriptase inhibitor; intracellular phosphorylation gives tenofovir diphosphate, an obligate chain-terminator competing with endogenous dATP at HIV reverse transcriptase. Combined with emtricitabine (FTC), a cytidine analogue NRTI structurally similar to lamivudine but with longer intracellular half-life. The fixed-dose combination at 300mg TDF + 200mg FTC is the standard adult once-daily dose; paediatric weight-band tablets follow WHO scaled doses.
Strengths stocked
Adult: 300mg TDF + 200mg FTC once daily (the standard tablet, highest tender volume globally). Paediatric weight-band: 200mg/167mg and 150mg/100mg (per WHO ART paediatric dosing tables). The TAF (tenofovir alafenamide) 25mg + FTC 200mg formulation (Descovy generic) is a separate listing in our antivirals catalogue — same target population in HIV ART + PrEP, different PK profile (lower systemic tenofovir exposure, gentler on kidney + bone, slightly higher cost in the donor-funded space).
Indications
HIV-1 ART first-line backbone (TLD + alternatives); HIV-1 second-line; HIV-2 ART; HIV PrEP daily oral + 2-1-1 on-demand; HBV mono-infection and HIV/HBV co-infection; HIV post-exposure prophylaxis (PEP); paediatric HIV ART ≥17 kg. WHO EML core. Once-daily oral, lifelong therapy in HIV; PrEP duration as long as HIV exposure risk persists.
Storage
15-30°C, in original blister to protect from moisture. Tablets are moisture-sensitive — keep blister sealed until use. Standard ambient-temperature dispatch lane; no cold-chain. Discard tablets showing surface degradation or discolouration.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Aluminium-aluminium blister, 30 tablets per blister-pack (one month supply), or 90-tablet (three months) and 1000-tablet bulk-pharma packs for tender supply. Outer carton and leaflet in destination-regulator language. HBV reactivation warning on PrEP discontinuation prominently set on patient leaflet (PrEP cessation in HBV-infected patients can cause severe hepatitis flare). HIV-test-before-PrEP-start protocol documented per WHO PrEP guidelines.
Global Fund pooled procurement, PEPFAR, country HIV programmes — across thirty markets.
India is our origin. We do not sell into the Indian market. TDF/FTC is exported only.
Global Fund Pooled Procurement Mechanism + PEPFAR
Global Fund Pooled Procurement Mechanism (PPM) is the world's single largest HIV ART buyer — sources almost exclusively from WHO-Prequalified Indian generic manufacturers for sub-Saharan Africa, Asia and Latin America. PEPFAR (US President's Emergency Plan for AIDS Relief) buys directly through Supply Chain Management System (SCMS) and through country-level USAID missions. Both source TDF/FTC and TLD as the WHO-recommended first-line backbone. M Care holds WHO PQ-listed lines for Global Fund + PEPFAR tender qualification; engagement is via the PPM e-tender platform and PEPFAR SCMS direct procurement.
Nigeria, Kenya, South Africa, Tanzania, Uganda, Ethiopia, Zambia, Mozambique
Country-level public-sector HIV programme tenders: NACA Nigeria + NAFDAC registration; NASCOP Kenya + KEMSA central procurement; South Africa national ART tender via NDOH (the world's largest single-country HIV ART tender, Mylan and Aurobindo Indian-generic-dominated); TMDA + MSD Tanzania; NDA + NMS Uganda; EFDA + EPSS Ethiopia; Zambia ZNPS; Mozambique CMAM. WHO PQ + SAHPRA / NAFDAC / PPB / EFDA registration are the ticket. M Care engages on these tenders directly through the WHO PQ-listed manufacturer roster.
United Kingdom
NHS England TDF/FTC sourcing has shifted to Indian generics post-Truvada patent expiry (2017). Where the primary contract holder cannot fill, the MHRA Specials / named-patient import route is available — see MHRA Specials. NHS PrEP programme (England, Scotland, Wales, Northern Ireland) sources biosimilar/generic TDF/FTC for the daily oral PrEP regimen. Sexual-health clinics and HIV outpatient pharmacies are the key dispensing channels.
GCC (UAE, KSA, Kuwait, Qatar, Bahrain), Egypt, Brazil, Philippines
Through local licensed importers, against MoH HIV-programme tender awards (NUPCO and Saudi MoH for KSA; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH; MoPH Qatar; NHRA Bahrain). Egypt's national HCV elimination programme + HIV care, Brazil's UNIFAR national programme, Philippines DOH HIV care. SFDA, MoHAP, ANVISA and FDA Philippines registrations supported with full CTD dossier.
HIV-test-before-PrEP, HBV reactivation on PrEP cessation, renal monitoring, drug-drug interactions — TDF/FTC is well-tolerated but the safety nets matter.
Standard adult dosing is one tablet (300mg TDF + 200mg FTC) once daily for HIV ART (with dolutegravir or alternative third agent) and for daily oral PrEP. Pre-PrEP HIV testing is mandatory — starting PrEP in an undiagnosed HIV-positive patient causes drug resistance to the NRTI backbone. WHO and CDC guidance requires baseline HIV antigen-antibody test plus repeat testing every 3 months. HBV reactivation on PrEP discontinuation: TDF and FTC both have HBV activity; abrupt discontinuation in HBV-co-infected patients causes severe hepatitis flare (deaths reported). Pre-PrEP HBV screening (HBsAg, anti-HBs, anti-HBc) is mandatory; HBV-positive patients need ongoing HBV antiviral cover after PrEP cessation. Renal monitoring: TDF causes proximal-tubule dysfunction and Fanconi syndrome in 1-3% of long-term users; baseline + 3-monthly creatinine and phosphate; switch to TAF formulation if eGFR <60. Bone density: TDF reduces BMD ~1-2%; reversed on discontinuation; clinically relevant only in adolescents and post-menopausal women with osteoporosis risk factors. Drug-drug interactions: TDF + didanosine combination is contraindicated (didanosine toxicity); rifampicin and phenytoin reduce TDF/FTC efficacy modestly; PPIs reduce FTC absorption (separate by 2 hours). 2-1-1 on-demand PrEP: 2 tablets 2-24 hours before sex, 1 tablet 24h after sex, 1 tablet 48h after sex (per IPERGAY / French ANRS protocol; effective only in MSM, not other populations). Daily PrEP is the global default per WHO. Pregnancy: TDF/FTC is safe in pregnancy and breastfeeding; preferred ART in pregnant HIV-positive women per WHO.
The documentation pack a regulator actually asks for.
TDF/FTC is a WHO EML core-list molecule and WHO Prequalification active. Our role is manufacturer-facing — we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Bioequivalence study report against reference Truvada is included for generic substitution.
CoA and MoA, per batch
HPLC assay of TDF (≥98%) and FTC (≥98%), related substances (TDF: PMPA, monoester, fumarate counter-ion; FTC: enantiomeric purity, FTC degradation per Ph.Eur./USP), water content (Karl Fischer), dissolution profile (USP Apparatus 2, 0.1N HCl + phosphate buffer pH 6.8), content uniformity, hardness, friability — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies in the shipping pack. WHO-PQ certificate active for Global Fund and PEPFAR procurement qualification — this is the gating regulatory document for the donor-funded HIV space.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. HBV reactivation warning on PrEP discontinuation prominently set per FDA / EMA / MHRA black-box requirement. HIV-test-before-PrEP-start protocol documented. Renal monitoring schedule for long-term TDF users included. WHO ART and PrEP guideline references on the patient leaflet.
Temperature control
Pre-shipment validation on each shipper configuration. TDF/FTC tablets ship at 15-30°C ambient with humidity logging. Aluminium-aluminium blister foil is the moisture-barrier; container closure integrity tested on each consignment.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. HBV reactivation on PrEP cessation, TDF-related Fanconi syndrome / proximal tubule dysfunction, BMD reduction in long-term users, and rare lactic acidosis with hepatic steatosis remain the PSUR priority signals.
WHO ART backbones, HCV cure, HBV co-treatment.
TDF/FTC pairs with dolutegravir as the WHO-recommended TLD first-line, or with the EFV / PI-r alternatives. Our antivirals cluster carries the full ART + HCV + HBV roster.
Dolutegravir
Integrase inhibitor, the third agent of TLD. 50mg tablets.
Tenofovir alafenamide + Emtricitabine
TAF/FTC (Descovy generic) — gentler kidney + bone profile than TDF.
Sofosbuvir + Velpatasvir
Pan-genotypic HCV direct-acting antiviral. 400mg/100mg tablets.
Lamivudine
NRTI, paediatric ART weight-band alternative. 150mg / 300mg tablets.
All antivirals →
100+ antiviral SKUs: ART, HCV DAAs, HBV antivirals, influenza, CMV, COVID antivirals.
Anti-infectives →
ICU-grade antibacterials and antifungals.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (300/200mg adult; paediatric weight-band tablets), tablet count, destination, Global Fund / PEPFAR / NACA / NASCOP / NDOH / Egypt MOH / NHS PrEP / NGO supply, target delivery. Flag if WHO PQ documentation, HBV-reactivation black-box compliance set, or paediatric weight-band scaling material is needed.
- We route to the right line. Multiple WHO-GMP TDF/FTC lines on the M Care roster, all WHO PQ-active for Global Fund + PEPFAR qualification. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB / CIF price (Global Fund pricing benchmark applied), lead time, dossier status per destination, WHO PQ certificate, BE study report against Truvada reference, and the documentation pack. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane with humidity logging, in-transit temperature logging, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal/humidity logs archived for the full shelf life. Pharmacovigilance contact opened on registration; HBV reactivation, Fanconi syndrome, BMD reduction and rare lactic acidosis remain the PSUR priority signals.
TDF/FTC supply — the specific questions.
What strengths and pack formats of TDF/FTC do you supply?
Adult 300mg TDF + 200mg FTC once-daily tablet (the standard tender format globally — Aluminium-aluminium blister, 30 tablets per blister for one-month supply, 90-tablet 3-month packs, or 1000-tablet bulk-pharma packs for institutional tender). Paediatric weight-band tablets at 200mg/167mg and 150mg/100mg per WHO scaled dosing tables. Pack labelling supports WHO-recommended weight-band paediatric guidance. The TAF/FTC formulation (Descovy generic) is a separate biosimilar listing in our antivirals catalogue — same target population in HIV ART + PrEP, different PK profile.
Is your TDF/FTC WHO Prequalified for Global Fund and PEPFAR procurement?
Yes — multiple M Care partner facilities hold active WHO Prequalification for the adult and paediatric TDF/FTC formulations. The WHO PQ certificate is included in the shipping documentation pack. Global Fund Pooled Procurement Mechanism (PPM) and PEPFAR Supply Chain Management System (SCMS) both require WHO PQ as the gating regulatory ticket; we engage on PPM e-tender platform and PEPFAR direct procurement against this status. Country-level tenders (NACA Nigeria, NASCOP Kenya, South Africa NDOH national ART, TMDA Tanzania, NDA Uganda, EFDA Ethiopia) typically require both WHO PQ and country-specific registration (NAFDAC, PPB, SAHPRA, EFDA, etc) — we hold both.
Can you supply TDF/FTC for HIV PrEP programmes specifically?
Yes. TDF/FTC is the standard daily oral PrEP regimen globally; we supply against PrEP programmes including NHS England PrEP, NHS Scotland, NHS Wales, US PEPFAR PrEP rollout, South Africa national PrEP programme, Kenya PrEP roll-out, Brazil PrEP programme, and a growing list of country-level PrEP scale-ups. Documentation includes the HIV-test-before-PrEP-start protocol per WHO 2021 PrEP guidance, the HBV reactivation warning on PrEP discontinuation, and the renal-monitoring schedule for long-term TDF use. The 2-1-1 on-demand PrEP regimen for MSM (per French ANRS / EACS guidance) uses the same tablet — distinct dispensing protocol but same product.
Which markets can you ship TDF/FTC into?
Global Fund Pooled Procurement Mechanism + PEPFAR (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, Zambia ZNPS, Mozambique CMAM); UK NHS PrEP + outpatient HIV pharmacies; GCC (UAE, Saudi Arabia, Kuwait, Qatar, Bahrain) through licensed local importers; Egypt national HCV/HIV programmes; Brazil UNIFAR; Philippines DOH HIV care; Germany under §72 AMG, France under ANSM-equivalent route. We do not supply into India. Full market coverage is at markets.
What documentation is included with a TDF/FTC consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC TDF + FTC assays, related substances per Ph.Eur./USP, water content by Karl Fischer, dissolution profile, content uniformity, hardness, friability), Method of Analysis, BE study report against Truvada reference, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate, Certificate of Origin (chamber-attested), destination-language pack insert with HBV-reactivation black-box warning + HIV-test-before-PrEP protocol + renal-monitoring schedule, and temperature/humidity logs from pre-dispatch through on-arrival. PV contact nominated on registration.
Do you provide CTD dossiers for TDF/FTC registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. TDF/FTC has a well-established CMC template — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. WHO PQ dossier is the gating document for Global Fund and PEPFAR; that is held actively across multiple manufacturer lines on our roster. See dossier preparation.
What are typical lead times for TDF/FTC orders, and does it need cold-chain transit?
For Global Fund PPM tender awards, lead times are set in the award contract (typically 60-120 days from award to first delivery). For PEPFAR direct procurement, similar 60-90 day windows. For country-level tenders (NACA, NASCOP, NDOH), lead times set by the tender award document. For UK NHS PrEP and ad-hoc supply with urgency flagged, air-freight from Mumbai can be on a flight within 72 hours. Made-to-order batches run 8-12 weeks inclusive of QC release and destination artwork. TDF/FTC tablets do not require cold-chain in transit — they ship at 15-30°C ambient with humidity logging. Aluminium-aluminium blister foil is the moisture-barrier.
Send the specifics. You'll have a price inside one working day.
Strength (adult 300/200mg / paediatric weight-band), tablet volume, destination, Global Fund / PEPFAR / country HIV programme / NHS PrEP / NGO, target delivery, WHO PQ documentation requirement. That's the enquiry. Everything else is on us.