Tenofovir Disoproxil Fumarate 300mg: Indian exporter of the single-agent TDF tablet for chronic hepatitis B and standalone tender supply.
Plain tenofovir disoproxil fumarate (TDF) 300mg, supplied as a single-agent tablet, not the TDF/FTC fixed-dose combination. Its principal role is chronic hepatitis B monotherapy, and it is also sourced as an individual tender line by programmes building a regimen from separately-supplied components. Need the HIV combination instead? See tenofovir + emtricitabine.
Single-agent TDF 300mg, distinct from the TDF/FTC combination, WHO EML listed, multiple WHO-GMP partner lines for hepatitis B and standalone tender supply.
Active ingredient
Tenofovir disoproxil fumarate (TDF), an oral prodrug of tenofovir. Once absorbed, tenofovir is phosphorylated intracellularly to tenofovir diphosphate, a chain-terminating nucleotide analogue that inhibits both HIV reverse transcriptase and HBV polymerase. Supplied here as a single active ingredient, with no fixed-dose partner: the tablet you are sourcing is TDF alone, not TDF combined with emtricitabine.
Strengths stocked
300mg once-daily adult tablet, equivalent to 245mg tenofovir disoproxil free base, the standard strength for chronic hepatitis B monotherapy and standalone tender lines. Paediatric weight-band tablets at 250mg, 200mg and 150mg follow the same free-base equivalence convention. Every strength here is single-agent: no emtricitabine, no third component.
Indications
Chronic hepatitis B monotherapy is the flagship single-agent use, in HBV mono-infection and in HIV/HBV co-infection as the anti-HBV component of a wider regimen. Within HIV treatment, TDF is supplied as an individual tablet for combination with separately-sourced agents; it is never dispensed as HIV monotherapy. WHO EML listed for both roles.
Storage
Room temperature, below 30°C, in the original blister to protect the tablet against moisture uptake. No cold-chain requirement applies. Standard ambient-temperature dispatch lane with humidity logging maintained from the Indian facility through to on-arrival inspection.
Shelf life
36 months from manufacture, minimum 24 months remaining confirmed at dispatch. Standard for the film-coated tablet dosage form; consignments below the agreed minimum remaining shelf life are not shipped.
Pack format
Aluminium-aluminium blister, typically 30 tablets per blister-pack for one month of continuous therapy, plus 90-tablet and bulk-pharma pack options for institutional and tender-scale supply. Outer carton and pack insert in destination-regulator language, with discontinuation and hepatic-flare wording set per standard hepatitis B labelling practice.
Hepatology units, national hepatitis B programmes and tender desks: single-agent TDF exporter across the markets we serve.
India is our origin. We do not sell into the Indian market. Tenofovir disoproxil fumarate 300mg is exported only, as a single-agent line kept separate from the TDF/FTC combination.
United Kingdom
NHS hepatology and infectious disease services manage chronic hepatitis B with oral nucleos(t)ide therapy, tenofovir disoproxil fumarate among the standard options alongside entecavir. Where the primary contract line cannot fill a specific order, the MHRA Specials or named-patient import route applies for a single-agent TDF product, kept distinct from any combination formulary line.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Hepatitis B carries meaningful prevalence across the Gulf, and Ministry of Health screening and treatment programmes procure oral antivirals through licensed local importers and central tender platforms. Single-agent TDF is specified where the tender line calls for the standalone molecule rather than an HIV fixed-dose combination.
Nigeria, Kenya, Ghana, South Africa
Sub-Saharan Africa carries among the highest chronic hepatitis B burdens globally, and national programmes increasingly fund oral antiviral treatment alongside HIV services. Public-sector tenders, registered through NAFDAC into Nigeria, PPB into Kenya and SAHPRA into South Africa, commonly specify single-agent TDF for hepatitis B lines that sit outside the HIV ART budget.
Germany
Import under §72 AMG, with Qualified Person certification and a BfArM-format dossier where registration is pursued. German hepatology practice follows EASL guidance, in which TDF and entecavir are the preferred oral options for chronic hepatitis B, so demand runs through specialist gastroenterology and infectious disease clinics rather than general wholesale.
Hepatic flare on discontinuation, renal clearance, bone density: single-agent TDF has its own safety file, separate from the combination.
Tenofovir disoproxil fumarate 300mg is licensed as oral monotherapy for chronic hepatitis B, a distinct role from its place inside HIV regimens, where it is always combined with other agents and never dispensed alone. Hepatic flare on discontinuation is the defining safety signal for direct HBV treatment: stopping nucleos(t)ide therapy can trigger a severe, occasionally fatal, flare from viral rebound, so withdrawal is a clinical decision made under monitoring, not a routine stopping point. Renal function is the other recurring theme: TDF is renally cleared, dose-interval adjustment applies at reduced creatinine clearance, and proximal tubular dysfunction, a Fanconi-type picture, is a recognised though uncommon long-term finding, so baseline and periodic renal monitoring is standard practice. Bone mineral density shows a small, reversible reduction with long-term TDF exposure, most relevant in adolescents and in patients who already carry fracture risk. None of this is dosing instruction; it is what a receiving pharmacist should already hold on file before the first shipment lands.
What a hepatitis B programme tender file needs from the supply side.
Tenofovir disoproxil fumarate 300mg is a WHO Essential Medicines List molecule in its own right. Our role sits between the Indian WHO-GMP facility and your regulatory or procurement team, for the single-agent line specifically.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it, with a Module 2 quality overall summary. Filed against the single-agent TDF 300mg product, not against the fixed-dose combination dossier.
CoA and MoA, per batch
HPLC assay of tenofovir disoproxil fumarate, related substances per Ph.Eur./USP monograph, water content by Karl Fischer, dissolution profile, content uniformity, hardness and friability, signed by the manufacturer's authorised QC head on every batch.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it, with notarised copies in the shipping pack. Where the sourcing line holds WHO Prequalification for standalone TDF 300mg, that certificate is included.
Pack insert, labels, artwork
Destination-language patient information leaflet and regulator-standard labelling. Hepatic flare risk on treatment discontinuation is set out per standard hepatitis B labelling practice, alongside the renal and bone-density monitoring points relevant to long-term use.
Temperature control
Pre-shipment thermal validation on the shipper configuration used. TDF 300mg tablets ship at ambient temperature with humidity logging; the blister is the primary moisture barrier, and container closure integrity is checked on each consignment.
Pharmacovigilance
A local PV partner or a named contact is arranged in the destination market on registration. Hepatic flare on discontinuation, renal proximal tubular dysfunction and long-term bone density reduction remain the priority signals for periodic safety update reporting.
Need the HIV combination, an ART partner agent, or the other hepatitis B option? Start here.
Single-agent TDF covers hepatitis B monotherapy and standalone tender lines. For the HIV ART backbone or PrEP, the fixed-dose combination is the right product; our antivirals cluster carries both.
Tenofovir + Emtricitabine
The TDF/FTC fixed-dose combination: HIV ART backbone and PrEP. Choose this, not the single-agent page, if the requirement is HIV treatment or prevention.
Entecavir
The other WHO-preferred oral option for chronic hepatitis B monotherapy, a guanosine nucleoside analogue with a different resistance profile from TDF.
Dolutegravir
Integrase inhibitor, the standard third agent when a buyer is building an HIV regimen around a separately-sourced TDF tablet rather than the fixed-dose combination.
Lamivudine
NRTI with activity against both HIV and HBV, historically paired with TDF before FTC became the standard partner. Paediatric ART weight-band alternative.
All antivirals →
100+ antiviral SKUs: ART components, HCV DAAs, HBV antivirals, influenza, CMV and COVID antivirals.
Anti-infectives →
ICU-grade antibacterials and antifungals for the hospital pharmacies we already supply.
Single-agent TDF: send strength, volume and destination for a quote.
- Send us the specifics. Strength (adult 300mg or paediatric weight-band), pack format, destination, and whether the requirement is a hepatitis B programme line or a standalone component within a wider HIV regimen. Flag if WHO PQ or WHO EML documentation is needed.
- We route to the right line. Selection runs across the WHO-GMP TDF 300mg lines on the M Care roster, with preference for facilities already holding WHO Prequalification or the relevant destination registration.
- Commercial and regulatory offer. Price, dossier status per destination, WHO PQ certificate where held, and the bioequivalence study reference are confirmed against your specific order and destination.
- Order, produce, release, ship. QC release on the Indian side, ambient-temperature dispatch with humidity logging, in-transit temperature logging and an on-arrival inspection record.
- After delivery. Batch records, CoA and temperature logs are archived for the full shelf life. A pharmacovigilance contact is opened on registration, with hepatic flare and renal signals as the standing priority.
Single-agent TDF supply, the specific questions.
What is tenofovir disoproxil fumarate 300mg, and how does this page differ from your TDF/FTC combination page?
Tenofovir disoproxil fumarate (TDF) 300mg is the single-agent tablet: tenofovir alone, with no emtricitabine and no fixed-dose partner. This page covers that standalone product, used mainly for chronic hepatitis B monotherapy and for tender lines that specify the molecule on its own. Our tenofovir + emtricitabine page covers the TDF/FTC fixed-dose combination used as the HIV antiretroviral therapy backbone and for PrEP. If your requirement is HIV treatment or prevention, that combination page is the right one; if it is hepatitis B or a standalone TDF component, you are in the right place.
Is single-agent TDF used to treat HIV on its own, or is it strictly a hepatitis B medicine?
Both roles exist, but they work differently. For chronic hepatitis B, TDF 300mg is licensed as monotherapy: one active ingredient, given alone, is standard practice. For HIV, TDF is never given as monotherapy; it is always combined with other antiretroviral agents, because single-agent HIV therapy drives rapid resistance. Where a buyer sources standalone TDF for an HIV programme, it is because the regimen is being assembled from separately-supplied tablets rather than a pre-formulated combination, not because the patient takes TDF alone. The distinction matters for how the product is specified on a tender or purchase order.
Why would a buyer specify single-agent TDF instead of the fixed-dose combination?
Three recurring reasons. First, the indication is hepatitis B alone, where FTC adds no clinical value and only the TDF component is needed. Second, the buyer is a programme that procures ART components separately for inventory flexibility, pairing TDF with a locally-preferred partner agent rather than a fixed ratio. Third, a tender specification names the single-agent molecule explicitly, common where national procurement lists price and register TDF and its partner agents as distinct line items rather than one combination SKU. In each case, the single-agent tablet is the correct product to quote against, not the FDC.
What strengths and pack formats of TDF 300mg do you supply?
300mg once-daily adult tablet, equivalent to 245mg tenofovir disoproxil free base, the standard strength for chronic hepatitis B monotherapy and for standalone tender lines. Paediatric weight-band tablets are available at 250mg, 200mg and 150mg, following the same free-base equivalence convention as the adult strength. Packing runs from Aluminium-aluminium blister for routine supply through to bulk-pharma packs for institutional and tender-scale orders, with outer carton and pack insert produced in destination-regulator language. Confirm your exact strength and pack requirement at enquiry stage and we will match it to a WHO-GMP line carrying that specification.
Is standalone TDF 300mg WHO Prequalified and listed on the WHO Essential Medicines List?
Tenofovir disoproxil fumarate is listed on the WHO Model List of Essential Medicines, first added for HIV antiretroviral therapy and later extended to cover chronic hepatitis B treatment. Multiple Indian generic manufacturers separately hold active WHO Prequalification for the standalone 300mg tablet, distinct from prequalification held on the fixed-dose combination. Where your programme requires a WHO PQ-listed single-agent line specifically, tell us at enquiry stage and we will route the order to a facility that holds that listing for the standalone product, with the certificate included in the documentation pack.
What renal and bone-density monitoring considerations apply to long-term TDF use?
TDF is renally cleared, and dose-interval adjustment applies at reduced creatinine clearance; proximal tubular dysfunction, a Fanconi-type picture, is a recognised though uncommon finding with long-term use, so baseline and periodic renal monitoring is standard clinical practice around the molecule. A small, reversible reduction in bone mineral density is also associated with long-term exposure, most relevant in adolescents and in patients who already carry fracture risk. None of this changes how the product is supplied, but it is worth having on file for the clinical team receiving the consignment, alongside the hepatic flare risk on treatment discontinuation.
What markets, documentation and lead times apply to a bulk or tender order of TDF 300mg?
We supply into hospital pharmacies, hepatology and infectious disease services, MoH tender desks and national hepatitis B programmes across the export markets we serve; we do not sell into India. Every consignment ships with a batch-specific Certificate of Analysis, Certificate of Pharmaceutical Product, WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where the sourcing line holds one, Certificate of Origin and a destination-language pack insert. Lead time depends on order volume, destination registration status and whether the line is made-to-order or ex-stock; we confirm a specific date against your enquiry rather than quoting a generic figure.
Send the specifics. We will confirm the single-agent line and a price.
Strength, pack format, destination, and whether the requirement is a hepatitis B programme or a standalone component within a wider regimen. That is the enquiry; the documentation and sourcing are on us.