Baraclude (entecavir) is a nucleoside analogue reverse transcriptase inhibitor on the WHO Model List of Essential Medicines for chronic hepatitis B, and both the originator brand and MHRA/EMA-approved generic entecavir tablets are available for tender and hospital supply.
M Care Exports is a merchant exporter for Baraclude (entecavir), the Bristol Myers Squibb-originated nucleoside analogue reverse transcriptase inhibitor dosed once daily for chronic hepatitis B virus infection. We source the originator brand and MHRA and EMA-approved generic entecavir tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Entecavir exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes entecavir tablets against buyer specification: brand (Baraclude) or generic, strength (0.5 mg or 1 mg), and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the 1 mg strength serves lamivudine-refractory and decompensated-liver-disease patients while 0.5 mg covers nucleoside-naive treatment, we confirm the buyer's patient mix before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Nucleoside analogue reverse transcriptase inhibitor (hepatitis B antiviral), sourced and documented for export.
Entecavir is a nucleoside analogue reverse transcriptase inhibitor: it is phosphorylated intracellularly to its active triphosphate, which competes with the natural substrate to inhibit hepatitis B viral DNA polymerase, blocking priming, reverse transcription and viral DNA synthesis. It carries a high genetic barrier to resistance, which is why WHO guidance favours it alongside tenofovir over older agents such as lamivudine. It is dosed orally, not injected, and needs no reconstitution. The FDA and EU labels' flagship indication is chronic hepatitis B in adults and children aged two and above with evidence of active viral replication and persistently elevated ALT, in either compensated or decompensated liver disease. Baraclude is supplied as 0.5 mg and 1 mg film-coated tablets, taken once daily; a 0.05 mg/mL oral solution is also labelled in the US for paediatric and swallowing-difficulty use.
Active ingredient
Entecavir. Nucleoside analogue reverse transcriptase inhibitor (hepatitis B antiviral).
Forms and strengths
0.5 mg film-coated tablet; 1 mg film-coated tablet.
Indications
Entecavir, a nucleoside analogue reverse transcriptase inhibitor indicated for chronic hepatitis B virus infection with evidence of active viral replication and persistently elevated ALT, in compensated or decompensated liver disease. Supplied as originator Baraclude and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
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 for entecavir are mainly hospital hepatology and infectious-disease pharmacies, MoH tender desks running national hepatitis B programmes, and NGO or public-health procurement bodies (national viral hepatitis elimination programmes, Global Fund-adjacent initiatives) sourcing a WHO EML antiviral at volume, plus licensed importers and wholesalers stocking both the originator and generic lines. In the UK, supply runs through named-patient import or MHRA Specials where a specific generic is not yet locally registered; in the GCC, a licensed local agent registers the product with SFDA, MOHAP or the equivalent MoH before a tender bid; across Africa, NAFDAC, PPB and SAHPRA registration plus national essential-medicines-list listing typically precede a public-sector hepatitis B programme order; in Germany, import runs under section 72 AMG with BfArM dossier support and QP batch certification. India is our export origin only: we do not supply the Indian domestic market.
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 entecavir.
Entecavir dosing is indication- and treatment-history-dependent, not one-size-fits-all: nucleoside-naive adults with compensated disease take 0.5 mg once daily, while lamivudine-refractory patients, those with known resistance mutations, or anyone with decompensated liver disease take 1 mg once daily on an empty stomach, at least two hours from food. Renal function should be checked before dispatch planning around a tender, since creatinine clearance below 50 mL/min requires a reduced dose or extended dosing interval per the label's renal-adjustment table. The boxed warning covers three points a supply desk should flag to the prescriber: severe acute hepatitis B exacerbation on treatment discontinuation, which needs close hepatic monitoring after stopping; a risk of HIV resistance emerging if entecavir is used in HIV/HBV coinfection without concurrent HAART; and lactic acidosis with hepatomegaly, a class effect of nucleoside analogues. Tablets need no cold-chain handling and are stored below 30°C, protected from moisture in the original pack.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, entecavir travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Entecavir has been on the WHO Model List of Essential Medicines' core list since 2015, under medicines for hepatitis B, nucleoside/nucleotide reverse transcriptase inhibitors, and is also listed on the EMLc for children aged two to eleven, reflecting WHO's preference for entecavir and tenofovir over lamivudine on resistance grounds. On the brand-versus-generic question, Baraclude remains the Bristol Myers Squibb originator; MHRA and EMA-approved generic entecavir tablets from multiple manufacturers, including Viatris and Aristo, are separately registered and bioequivalence-confirmed in the UK and EU, so buyers genuinely have a brand-or-generic choice once local registration is confirmed. Entecavir is not a controlled substance and carries no scheduling restriction in the markets M Care serves; tender frequency tracks national hepatitis B elimination programme cycles rather than a fixed calendar, so M Care confirms current registration status with the sourcing partner ahead of each quote.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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 entecavir.
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 entecavir.
- 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.
Entecavir supply, the specific questions.
Does a generic version of Baraclude exist?
Yes. MHRA and EMA-approved generic entecavir tablets are registered and marketed in the UK and EU alongside the originator brand Baraclude, from manufacturers including Viatris and Aristo. Registration status for generic entecavir varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Baraclude to our market?
Yes, on an import basis. We source Baraclude through Bristol Myers Squibb's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of entecavir tablets are available?
0.5 mg and 1 mg film-coated tablets, matching the Baraclude strengths. Tell us your patient mix, nucleoside-naive versus lamivudine-refractory or decompensated disease, and we quote the strength split accordingly.
Is entecavir on the WHO Essential Medicines List?
Yes. Entecavir has been on the WHO Model List of Essential Medicines' core list since 2015, under nucleoside/nucleotide reverse transcriptase inhibitors for hepatitis B, and is also on the EMLc for children aged two to eleven. This makes it a standard reference agent for national hepatitis B tender specifications.
Does entecavir need cold-chain shipping?
No. Entecavir tablets are stored below 30°C, protected from moisture in the original pack. They travel on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care uses for biologics and insulins.
What dose of entecavir applies to lamivudine-experienced patients?
Patients who are lamivudine-refractory, have known resistance mutations, or have decompensated liver disease are dosed at 1 mg once daily on an empty stomach, rather than the 0.5 mg once-daily dose used for nucleoside-naive patients with compensated disease. M Care confirms the buyer's intended patient mix before quoting the strength split.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.