Harvoni (ledipasvir/sofosbuvir) is a once-daily NS5A and NS5B inhibitor tablet for chronic hepatitis C, with a labelled course set by genotype and cirrhosis status, and it needs no cold chain.
M Care Exports supplies Harvoni (ledipasvir/sofosbuvir), the Gilead hepatitis C tablet, and Indian-made ledipasvir/sofosbuvir lines to hospital pharmacies, hepatology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 90 mg/400 mg tablet, send the destination, the line you want and the quantity, and we quote per destination.
Ledipasvir/Sofosbuvir exporter and bulk supplier from India.
"We need a partner for Harvoni" is a typical enquiry from a hospital pharmacy or a hepatitis C tender desk. M Care is a merchant-exporter. We supply the originator brand and Indian-made lines, such as Ledifos 90 mg/400 mg tablets, Hepcinat LP tablets and Resof-L tablets, for destinations whose registration accepts them. We do not claim those Indian-made brands are registered in any destination, and we confirm that per enquiry. The quantity is easy to plan, because the US label packs the 90 mg/400 mg tablet as a bottle of 28 and the UK SmPC lists packs of 28 and 84. One tablet a day means a 12-week course is 84 tablets. The quote then turns on the line (originator or Indian-made), the pack, the volume, the registration route in the destination and Incoterms.
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.
Fixed-dose NS5A inhibitor and NS5B polymerase inhibitor combination, direct-acting antiviral for chronic hepatitis C, sourced and documented for export.
Harvoni combines ledipasvir, an NS5A inhibitor, with sofosbuvir, an NS5B polymerase inhibitor, in one tablet. The US label (Gilead Sciences, Inc., DailyMed page revised December 2024) covers chronic hepatitis C in adults and children aged 3 years and over: genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, genotype 1 with decompensated cirrhosis with ribavirin, and genotype 1 or 4 in liver transplant recipients with ribavirin. It lists a 90 mg/400 mg tablet and a 45 mg/200 mg tablet, plus 45 mg/200 mg and 33.75 mg/150 mg oral pellets for children. The adult dose is one 90 mg/400 mg tablet once daily. US durations are 12 weeks for most patients, 8 weeks as an option for some treatment-naive genotype 1 patients without cirrhosis, and 24 weeks for treatment-experienced genotype 1 patients with compensated cirrhosis. The EMA page lists Gilead Sciences Ireland UC as marketing authorisation holder, authorised on 17 November 2014, for adults and children aged 3 years and over. On emc the UK product is Ledipasvir/Sofosbuvir Gilead 90 mg/400 mg film-coated tablets (previously known as Harvoni), from Gilead Sciences Ltd. The SmPC says 8 weeks may be considered in previously untreated genotype 1 patients without cirrhosis, and covers genotype 3 patients with compensated cirrhosis or prior treatment failure, with ribavirin for 24 weeks. The WHO Essential Medicines electronic list names ledipasvir + sofosbuvir 90 mg + 400 mg tablet on the core list for hepatitis C, under non-pangenotypic direct-acting antiviral combinations, first added in 2015.
Active ingredient
Ledipasvir and sofosbuvir. Fixed-dose NS5A inhibitor and NS5B polymerase inhibitor combination, direct-acting antiviral for chronic hepatitis C.
Forms and strengths
90 mg/400 mg film-coated tablet (ledipasvir/sofosbuvir); 45 mg/200 mg film-coated tablet (ledipasvir/sofosbuvir, US label); 45 mg/200 mg oral pellets in unit-dose packet (US label); 33.75 mg/150 mg oral pellets in unit-dose packet (US label).
Indications
Ledipasvir/sofosbuvir (Harvoni) is a once-daily fixed-dose direct-acting antiviral from Gilead for chronic hepatitis C in adults and children aged 3 years and over, as set out in the US, EU and UK labelling.
Administration
Oral. Film-coated tablet; oral pellets (US label).
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 hepatology and infectious disease 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 Harvoni 90 mg/400 mg tablets for a hepatitis C programme" or "We need a partner for ledipasvir/sofosbuvir 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 accepts the originator brand, a regulator-registered version or an Indian-made line depends on its 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 ledipasvir/sofosbuvir.
Start with genotype and cirrhosis status, because the labelled course changes with both. The US label gives 12 weeks for most genotype 1, 4, 5 and 6 patients, 24 weeks for treatment-experienced genotype 1 with compensated cirrhosis, and ribavirin for 12 weeks in decompensated disease or after transplant. Screen for hepatitis B before the first tablet: the US label carries a boxed warning on hepatitis B reactivation, and the UK SmPC asks for HBV screening in all patients. Then check the medicine list. The US label does not recommend amiodarone with Harvoni because of serious symptomatic bradycardia. Antacids go 4 hours apart from the tablet, and the UK SmPC says proton pump inhibitors should not be taken before it. Rifampicin and St John's wort are not recommended in the US label and contraindicated in the UK SmPC. On packs, one 28-tablet bottle covers four weeks, so a 12-week course is three bottles.
The documentation pack a regulator actually asks for.
Harvoni is an ambient-temperature product, so no cold chain applies. The US label says store below 30 °C and dispense only in the original container, with 28 tablets and a desiccant in each bottle. The UK SmPC states a shelf life of 6 years and no special storage conditions. The US label carries a boxed warning on hepatitis B virus reactivation in patients coinfected with HCV and HBV. Registration status differs by region: the EMA page shows Harvoni authorised on 17 November 2014, and the EMA medicines list shows no centrally authorised generic of it. The UK emc lists the 90 mg/400 mg tablet as Ledipasvir/Sofosbuvir Gilead from Gilead Sciences Ltd. In the US, DailyMed lists an authorised generic from Asegua Therapeutics LLC. 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, and make no manufacturing or WHO claim for M Care itself.
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 ledipasvir/sofosbuvir.
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 ledipasvir/sofosbuvir.
- 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.
Ledipasvir/Sofosbuvir supply, the specific questions.
What decides the landed cost of Harvoni for an importer, and what about Harvoni price in Nigeria?
We do not publish prices. For an importer the landed cost depends on whether you want the originator Harvoni or an Indian-made line, the pack (28 or 84 tablets), the quantity, the registration route in the destination, and Incoterms. No cold chain applies, so freight is simpler than for refrigerated products. For Nigeria, the registration route set by the regulator decides which line can be imported, and we confirm it per enquiry. M Care Exports quotes per destination once you send the line, pack and volume.
Is there a Harvoni generic?
It depends on the region. In the US, DailyMed lists ledipasvir and sofosbuvir tablets from Asegua Therapeutics LLC, labelled as an authorised generic of Harvoni. In the EU, the EMA medicines list shows Harvoni from Gilead Sciences Ireland UC and no centrally authorised generic. On emc, the UK 90 mg/400 mg tablet is listed as Ledipasvir/Sofosbuvir Gilead from Gilead Sciences Ltd. M Care Exports also supplies Indian-made lines such as Ledifos, Hepcinat LP and Resof-L. We do not call them registered in any destination unless that regulator says so.
What is the Harvoni generic name?
The generic (non-proprietary) name is ledipasvir/sofosbuvir, written ledipasvir and sofosbuvir in the US. In the UK, emc now lists the product as Ledipasvir/Sofosbuvir Gilead 90 mg/400 mg film-coated tablets (previously known as Harvoni), from Gilead Sciences Ltd. Tender specifications may use either the brand or the combination name. Send the wording you need and M Care Exports confirms the matching line for your destination.
I'm looking for the Harvoni 90-400 mg tablet. What packs exist?
Each 90 mg/400 mg tablet holds 90 mg ledipasvir and 400 mg sofosbuvir. The US label packs it as a bottle of 28 with a desiccant. The UK SmPC lists cartons of 1 bottle of 28 tablets and, for the 90 mg/400 mg tablet, 84 tablets as 3 bottles of 28, with a note that not all pack sizes may be marketed. The US label also lists a 45 mg/200 mg tablet and oral pellets for children. Confirm the pack for your destination before ordering.
What is Harvoni used for as a hep C treatment, and what are the durations?
Harvoni treats chronic hepatitis C in adults and children aged 3 years and over. The US label covers genotypes 1, 4, 5 and 6, with 12 weeks for most patients, an 8-week option for some treatment-naive genotype 1 patients without cirrhosis, and 24 weeks for treatment-experienced genotype 1 patients with compensated cirrhosis. Ribavirin is added for decompensated cirrhosis and for transplant recipients. The UK SmPC also covers genotype 3 patients with compensated cirrhosis or prior treatment failure, with ribavirin for 24 weeks. Prescribers decide the regimen, and the destination label governs.
How does Harvoni compare with Epclusa on the label?
We compare on label facts only and do not recommend one over another. The US Harvoni label covers genotypes 1, 4, 5 and 6, with ledipasvir and sofosbuvir in one 90 mg/400 mg tablet. The US Epclusa label covers genotypes 1 to 6, with sofosbuvir and velpatasvir in one 400 mg/100 mg tablet, taken for 12 weeks, with ribavirin added in decompensated cirrhosis. Both are once-daily tablets. Our sofosbuvir and velpatasvir page covers the Epclusa and Sovaldi lines.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.
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.