Vemlidy (tenofovir alafenamide) is a once-daily 25 mg tablet for chronic hepatitis B with compensated liver disease, stored below 30 C with no cold chain, and sourced by M Care Exports for importers and tender desks per destination.
M Care Exports supplies Vemlidy (tenofovir alafenamide), the Gilead Sciences originator tablet for chronic hepatitis B, and quotes tenofovir alafenamide 25 mg from other licensed sources where a buyer's tender or registration allows it. It is a once-daily oral tablet taken with food. M Care is a merchant-exporter, not a manufacturer: we source through licensed channels and dispatch on a per-destination quote.
Tenofovir alafenamide exporter and bulk supplier from India.
"I'm looking for Vemlidy 25 mg for a hospital or tender" is the usual opening. We quote against your specification: originator Vemlidy or tenofovir alafenamide 25 mg from another source, the pack your registration names, the quantity, and the paperwork your regulator expects. The DailyMed label lists one presentation, a bottle of 30 tablets with a desiccant, so we confirm pack configuration against what is actually registered in your market before we price. Because the product is an ambient tablet, lead time depends on stock and documentation rather than on temperature-controlled lanes. If you need a partner for a recurring supply schedule rather than a single consignment, tell us the monthly volume and the destination, and the Mumbai desk will build the quote around your import licence and registration route.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
HBV nucleoside analog reverse transcriptase inhibitor, sourced and documented for export.
Tenofovir alafenamide is an HBV nucleoside analog reverse transcriptase inhibitor. The US label indicates Vemlidy for chronic hepatitis B virus infection in adults and paediatric patients 6 years of age and older who weigh at least 25 kg, with compensated liver disease. The dose is one 25 mg tablet once daily with food. The 25 mg tablet is equivalent to 28 mg of tenofovir alafenamide fumarate and is a yellow, round, film-coated tablet debossed GSI on one side and 25 on the other. The EMA page for the centrally authorised product gives the same age and weight band in its product details, and records Gilead Sciences Ireland UC as marketing authorisation holder, with the European Commission authorisation dated 9 January 2017. Note that the EMA overview text still refers to patients aged 12 years and older weighing at least 35 kg, so buyers should work from the current product information. The US label carries a boxed warning: stopping anti-hepatitis B therapy, including Vemlidy, may cause severe acute exacerbations of hepatitis B, and liver function should be monitored closely for at least several months after discontinuation. The label recommends no adjustment for creatinine clearance of 15 mL/min or greater. It is not recommended for decompensated hepatic impairment (Child-Pugh B or C).
Active ingredient
Tenofovir alafenamide (as tenofovir alafenamide fumarate). HBV nucleoside analog reverse transcriptase inhibitor.
Forms and strengths
25 mg film-coated tablet.
Indications
Once-daily oral antiviral for chronic hepatitis B virus infection in adults and paediatric patients 6 years of age and older who weigh at least 25 kg, with compensated liver disease. Taken with food.
Administration
Oral. Film-coated tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacies and liver or infectious-disease units, ministry of health and hospital tender desks, licensed importers and distributors in the GCC and Africa, and UK specialist pharmacy supply chains. Vemlidy is prescribed by hepatology and infectious-disease specialists, so demand comes through named formulary lines and tenders rather than open retail. We hear "we need a partner for hepatitis B antivirals" from distributors who want one source for the originator and an alternative on the same quote.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on tenofovir alafenamide.
Vemlidy is one tablet a day with food, so dispensing is simple, but three points matter on the ward and at the counter. First, the boxed warning concerns stopping, not starting: patients who discontinue anti-hepatitis B therapy can have a severe acute exacerbation, so a stock-out or an unplanned formulary switch is a clinical risk and not only a supply inconvenience. Liver function should be followed for at least several months after any stop. Second, renal and hepatic limits: no adjustment is recommended at creatinine clearance of 15 mL/min or above, and on chronic haemodialysis the dose is given after the session on dialysis days. The label does not recommend it in ESRD patients who are not on chronic haemodialysis, or in decompensated (Child-Pugh B or C) liver disease. Third, storage is below 30 C in the original bottle, which is supplied with a silica gel desiccant. Keep the desiccant in the bottle and do not decant into dosing aids for stock holding. No reconstitution, infusion set or cold chain applies.
The documentation pack a regulator actually asks for.
As an ambient oral tablet, Vemlidy ships on standard temperature-controlled-room lanes, not the validated cold-chain lanes M Care runs for biologics. Buyers instead need a batch certificate of analysis, export documentation for the dispatch route, and the dossier or registration reference that your regulator requires. The EU product is centrally authorised under EMEA/H/C/004169; the US label is the Gilead Sciences, Inc. DailyMed entry. For the generic situation, our fetched sources show the following. The EMA record we read lists Vemlidy only for this substance. Indian-made tenofovir alafenamide 25 mg tablets are also in our catalogue, sold in India as Tafero, Durataf, Hepbest, Tafnat, Tenohep AF and Tenvir AF, for destinations whose registration accepts them; we did not find an EU generic of the single-agent product. We confirm the registered source, strength and pack for each destination before quoting. M Care holds ISO 9001:2015 for the trading entity and works with WHO-GMP sourced manufacturers; the manufacturing credential belongs to the manufacturer.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside tenofovir alafenamide.
Tenofovir disoproxil fumarate
Nucleotide reverse-transcriptase inhibitor · chronic hepatitis B, HIV-1 antiretroviral therapy
Tenofovir + Emtricitabine
NtRTI + NRTI fixed-dose combination · WHO ART backbone · PrEP · HBV · WHO PQ active
Entecavir
Baraclude · nucleoside analogue for chronic hepatitis B
All antivirals & hiv
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for tenofovir alafenamide.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Tenofovir alafenamide supply, the specific questions.
What is the Vemlidy 25 mg price for an importer?
We do not publish a price, because the landed price is set per destination. The main factors are whether you want the originator Vemlidy or another licensed source of tenofovir alafenamide 25 mg, the pack and strength your registration names, the order quantity, the registration route in your country, the freight and insurance terms, and the Incoterm. Vemlidy is an ambient tablet stored below 30 C, so you are not paying for cold chain. M Care Exports quotes per destination, so send the country, quantity and importer details and the Mumbai desk will respond with a written offer.
What is Vemlidy 25 mg used for?
The US label indicates Vemlidy for chronic hepatitis B virus infection in adults and paediatric patients 6 years of age and older who weigh at least 25 kg, with compensated liver disease. The dose is one 25 mg tablet once daily with food. It is prescribed by specialists, and the label does not recommend it in decompensated (Child-Pugh B or C) liver disease. Always check the indication wording in your own country's approved product information, because the EMA overview text and the current product details give different age and weight bands.
Is there a Vemlidy generic, and what is the generic name?
The generic name is tenofovir alafenamide. The 25 mg tablet is equivalent to 28 mg of tenofovir alafenamide fumarate, which is how the EMA record names the active substance. Do not confuse it with tenofovir disoproxil fumarate, which is a different salt. On generics, the EMA record we read lists Vemlidy only. Indian-made tenofovir alafenamide 25 mg tablets, such as Tafero, Tenohep AF and Tenvir AF, are in our catalogue for destinations whose registration accepts them; we did not find an EU single-agent generic, so we quote what is registered for your destination.
What is in a Vemlidy 25 mg tablet pack, and how is it stored?
The US label describes 25 mg film-coated tablets, yellow and round, debossed GSI on one side and 25 on the other, supplied as a bottle of 30 with a silica gel desiccant. Storage is below 30 C. The EMA page does not state storage conditions and refers to the product information, so confirm the pack and storage text on the approved labelling for your market. There is no cold chain, reconstitution or injection device involved.
Who holds the authorisation for Vemlidy?
The US label lists Gilead Sciences, Inc. The EMA record names Gilead Sciences Ireland UC as marketing authorisation holder, with the European Commission authorisation granted on 9 January 2017 after a CHMP opinion on 10 November 2016. M Care Exports is a merchant-exporter and not the manufacturer. We source the originator through licensed channels and tell you at quotation stage which source and pack apply to your destination.
I'm looking for Vemlidy for a tender. What do you need from me?
Send the destination country, the strength and pack you want, the quantity and delivery schedule, whether the tender names Vemlidy or tenofovir alafenamide by INN, and any registration or importer licence references. If the tender needs a product registered with your national regulator, say which one, as the route differs by market and we confirm it before quoting. We then respond with the source, documents and lead time. Use the product catalogue to see other antivirals we supply.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.
