Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a once-daily single-tablet HIV-1 regimen from Gilead, supplied as a 50/200/25 mg tablet and a 30/120/15 mg paediatric-strength tablet, carries a US boxed warning on hepatitis B exacerbation, and needs no cold chain.
M Care Exports supplies Biktarvy (bictegravir/
Bictegravir/emtricitabine/tenofovir alafenamide exporter and bulk supplier from India.
"We need a partner for Biktarvy" is a typical enquiry from a hospital HIV pharmacy, a ministry of health tender desk or a licensed importer. M Care Exports is a merchant-exporter: we resell originator brands as well as generics, and we quote against your specification. Biktarvy is one molecule combination but more than one line. The adult tablet is 50 mg bictegravir, 200 mg emtricitabine and 25 mg tenofovir alafenamide. The US and EU texts also list a 30/120/15 mg tablet for children from 14 kg to under 25 kg, and the UK SmPC we read covers the 50/200/25 mg strength. Packs differ too: the US label lists 30-tablet bottles and 30-tablet blister packs, and the UK SmPC lists bottles and blisters of 30 and cartons of 90. The product is ambient-temperature, so freight is simple, but the quote still turns on the strength, the pack, the quantity, the destination's registration route and Incoterms. Buyers usually list it beside dolutegravir, tenofovir alafenamide and tenofovir/emtricitabine.
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.
Integrase strand transfer inhibitor combined with two nucleoside analogue reverse transcriptase inhibitors (antiretroviral), sourced and documented for export.
Biktarvy combines bictegravir, an integrase strand transfer inhibitor, with emtricitabine and tenofovir alafenamide (TAF), two nucleoside analogue reverse transcriptase inhibitors, in one tablet taken once daily. The US label (Gilead Sciences, DailyMed, updated September 2026) covers adults and paediatric patients weighing at least 14 kg in three settings: no antiretroviral treatment history; prior treatment without virologic suppression and without known or suspected resistance to the integrase class, emtricitabine or tenofovir; and replacing a stable regimen in virologically suppressed patients (HIV-1 RNA below 50 copies/mL) with no known or suspected resistance to bictegravir or tenofovir. The EMA lists Gilead Sciences Ireland UC as the marketing authorisation holder, authorised on 21 June 2018, for the treatment of HIV-1 infection in adults and children aged at least 2 years and weighing at least 14 kg. The UK emc SmPC lists Gilead Sciences Ltd, with the 50/200/25 mg tablet at one tablet daily from 25 kg. The US label dose is one 50/200/25 mg tablet daily from 25 kg, or one 30/120/15 mg tablet daily from 14 kg to under 25 kg.
Active ingredient
Bictegravir sodium, emtricitabine and tenofovir alafenamide fumarate. Integrase strand transfer inhibitor combined with two nucleoside analogue reverse transcriptase inhibitors (antiretroviral).
Forms and strengths
50/200/25 mg bictegravir/
Indications
Biktarvy (Gilead) is a once-daily single-tablet regimen for HIV-1 infection, supplied as 50/200/25 mg and 30/120/15 mg film-coated tablets, with a US boxed warning on post-treatment exacerbation of hepatitis B.
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 pharmacists in HIV and infectious diseases units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Biktarvy 50/200/25 mg for an HIV clinic" or "We need a partner for bictegravir, emtricitabine and tenofovir alafenamide tablets for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. Whether a destination has registered Biktarvy, accepts another source, or needs a named-patient import depends on the regulator, and M Care Exports confirms the route per enquiry.
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 bictegravir/emtricitabine/tenofovir alafenamide.
Check four things before building a pack list. First, the US boxed warning: severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who stopped products containing emtricitabine and/or tenofovir disoproxil fumarate, and this may occur on stopping Biktarvy, so hepatic function needs close monitoring after discontinuation. Second, interactions: the US label contraindicates dofetilide and rifampin, and the UK SmPC contraindicates rifampicin and St John's wort. Third, polyvalent cations: the US label says Biktarvy can be taken at least 2 hours before or 6 hours after aluminium or magnesium antacids, and that calcium or iron supplements or antacids can be taken together with it with food, while routine fasting co-administration is not recommended. Fourth, renal dosing: the US label recommends the tablet at creatinine clearance of 30 mL/min or more, and in virologically suppressed adults on chronic haemodialysis, with the dose given after dialysis. The UK SmPC recommends that the tablets are not chewed or crushed.
The documentation pack a regulator actually asks for.
Biktarvy is an ambient-temperature product, so no cold chain applies on the texts we read. The US label gives bottle storage below 30 °C with the silica gel desiccant left in place, and blister storage at 25 °C with excursions to 15 to 30 °C. The UK SmPC gives a 3-year shelf life and says to keep it in the original package to protect from moisture. Export consignments follow the pack and storage conditions of the supplied line. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting. M Care Exports is a merchant-exporter, not a manufacturer, and we state each manufacturer's quality documentation per line before quoting.
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 bictegravir/emtricitabine/tenofovir alafenamide.
Dolutegravir
Integrase inhibitor · HIV-1, alone or in fixed-dose combinations
Tenofovir/emtricitabine
NRTI combination · HIV-1 treatment and pre-exposure prophylaxis
Tenofovir alafenamide
Vemlidy and Indian 25 mg generics · 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 bictegravir/
emtricitabine/ 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.
Bictegravir/emtricitabine/tenofovir alafenamide supply, the specific questions.
What is the cost of Biktarvy for an importer?
M Care Exports does not publish a price for Biktarvy, because the landed price depends on the line and the destination. It is set by whether the supply is the Gilead originator or another source, the strength and pack (30 or 90 tablets), the quantity, the registration route in the destination country, and the Incoterms. Biktarvy needs no cold chain on the texts we read, so freight is simpler than for biologics. Send the destination, the strength and the quantity, and we quote per destination.
Is there a generic of Biktarvy, and what is its generic name?
The generic (non-proprietary) name is bictegravir, emtricitabine and tenofovir alafenamide. In the US, the FDA has issued a tentative approval letter (ANDA 217037) for bictegravir, emtricitabine and tenofovir alafenamide 50/200/25 mg tablets to Laurus Generics, as US agent for Laurus Labs. Tentative approval is not final approval to market. We have not confirmed a marketed generic from the EU or UK regulator pages we read. The Medicines Patent Pool page describes a Gilead licence for bictegravir for low- and middle-income countries, and says sublicensees may combine it with other antiretrovirals, but it does not name this combination. Availability therefore depends on the destination, and M Care Exports confirms the position per enquiry.
What is the Biktarvy tablet, and what strengths exist?
The adult Biktarvy tablet contains 50 mg bictegravir, 200 mg emtricitabine and 25 mg tenofovir alafenamide. The US label also lists a 30/120/15 mg tablet for paediatric use, and the EMA page lists the same two strengths. The US bottle holds 30 tablets with a desiccant, and the US blister packs hold 30 tablets. The UK SmPC lists bottles and blisters of 30, and cartons of 90, for the 50/200/25 mg tablet. We confirm which strength and pack your destination registers before we quote.
What is the Biktarvy dose?
Per the US label, the dose is one 50/200/25 mg tablet once daily in patients weighing at least 25 kg, and one 30/120/15 mg tablet once daily from 14 kg to under 25 kg. It can be taken with or without food, per the US label and the UK SmPC. The US label does not recommend the tablet at creatinine clearance of 15 to below 30 mL/min, and for virologically suppressed adults on chronic haemodialysis it gives the dose after dialysis. Follow the label of the destination; this page is not prescribing advice.
What are the side effects of Biktarvy, and what should a pharmacy watch for?
The key safety statement is the US boxed warning: severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate, and this may occur with Biktarvy, so hepatic function needs close monitoring after stopping. The labels also list contraindications with dofetilide and rifampin (US) and rifampicin and St John's wort (UK). For the full adverse reaction list, use the current label of the destination regulator.
What is Biktarvy used for, and is it used for PEP?
Biktarvy is used for the treatment of HIV-1 infection. The US label covers adults and paediatric patients weighing at least 14 kg who have no treatment history, who are not virologically suppressed and have no known or suspected resistance to the integrase class, emtricitabine or tenofovir, or who are virologically suppressed and switching. Post-exposure prophylaxis (PEP) is not a labelled indication in the US label we read, and M Care Exports does not suggest using it that way. Any use outside the label is a prescriber and national guideline decision. We supply against the licensed treatment indication.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.