Efavirenz is a non-nucleoside reverse transcriptase inhibitor for HIV-1, always given in combination, as a 600 mg tablet taken once daily on an empty stomach, and the originator Sustiva is discontinued in the US and withdrawn in the EU.
M Care Exports supplies efavirenz 600 mg tablets, and efavirenz capsules where a destination accepts them, to hospital pharmacies, MoH and programme tender desks, importers and distributors in the GCC, Africa and the UK. If you are looking for efavirenz after Sustiva left the market, send the destination, the presentation and the quantity, and we quote per destination.
Efavirenz exporter and bulk supplier from India.
"We need a partner for efavirenz 600 mg tablets" is a typical enquiry from an HIV programme pharmacy or a tender desk. M Care is a merchant-exporter: we supply originator or regulator-registered brands where they exist and Indian-made lines for destinations whose registration accepts them. The Indian-made lines on our catalogue include Efamat 600 mg tablets, Efcure 600 mg tablets and Estiva 600 mg capsules. We do not say these are registered in any destination, and the registration route is confirmed per enquiry. The originator situation matters for your tender wording. Drugs@FDA lists Sustiva capsules and tablets as discontinued, and the EMA lists both Sustiva and Stocrin as withdrawn, so the specification you receive may name a brand that is no longer sold. The landed price depends on the presentation, pack size, quantity, the destination's registration route and Incoterms. The UK SmPC for efavirenz 600 mg film-coated tablets states no special storage conditions, and the US label gives 20 to 25 °C, so no cold chain is needed.
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.
Non-nucleoside reverse transcriptase inhibitor (NNRTI), antiretroviral for HIV-1, sourced and documented for export.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. The US efavirenz tablet label (Aurobindo, DailyMed, revised 12/2023) lists it with other antiretrovirals for HIV-1 in adults and in children at least 3 months old who weigh at least 3.5 kg, as a 600 mg film-coated tablet. The US label carries weight-based paediatric dosing in a table that runs from 100 mg daily for 3.5 kg to under 5 kg up to 600 mg daily at 40 kg and above, using capsules below 40 kg; the US capsule label from the same company lists 50 mg, 100 mg and 200 mg capsules. The adult dose is 600 mg once daily on an empty stomach, preferably at bedtime. Drugs@FDA lists Sustiva (Bristol Myers Squibb) capsules of 50, 100 and 200 mg, and Sustiva tablets of 300 and 600 mg, all as discontinued, with a note that a Federal Register determination found they were not discontinued or withdrawn for safety or effectiveness reasons. The EMA page shows Sustiva withdrawn on 1 February 2024 and Stocrin withdrawn on 30 September 2025, both at the holder's request for commercial reasons, and the Sustiva page states that generic efavirenz medicines are authorised and marketed in the EU. The UK emc lists efavirenz 600 mg film-coated tablets under the efavirenz name, for example Efavirenz Milpharm, and a search of emc for Sustiva or Stocrin returned no result. The WHO electronic Essential Medicines List (eEML) lists efavirenz as a 600 mg tablet among the antiretrovirals, alongside two fixed-dose combinations: efavirenz with emtricitabine and tenofovir at 600 mg + 200 mg + 300 mg, and efavirenz with lamivudine and tenofovir at 400 mg + 300 mg + 300 mg.
Active ingredient
Efavirenz. Non-nucleoside reverse transcriptase inhibitor (NNRTI), antiretroviral for HIV-1.
Forms and strengths
600 mg film-coated tablet; 50 mg capsule (US generic label); 100 mg capsule (US generic label); 200 mg capsule (US generic label).
Indications
Efavirenz is a non-nucleoside reverse transcriptase inhibitor used with other antiretrovirals for HIV-1 infection. It is taken once daily on an empty stomach, preferably at bedtime.
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, HIV programme and MoH tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for efavirenz 600 mg tablets for a tender" or "We need a partner for efavirenz capsules". Each destination has its own registration or import route, 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 the regulator before quoting. For programme buyers in Africa, the procurement route depends on the destination regulator and the programme's own rules, and M Care Exports confirms it per enquiry. We supply both originator or regulator-registered brands and Indian-made lines, and we do not call Indian-made lines generics unless a source says so.
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 efavirenz.
Check the tablet first. The US label gives 600 mg once daily on an empty stomach, preferably at bedtime: bedtime dosing may improve tolerability of nervous system symptoms, and taking efavirenz with food raises its concentrations, which may increase adverse reactions. Swallow the tablet whole: the label says tablets must not be broken or crushed. Efavirenz induces CYP3A and CYP2B6, so screen the full medicines list: the US label names atorvastatin, pravastatin, simvastatin, methadone and hormonal contraceptives, and adds that voriconazole needs dose changes on both sides, with efavirenz cut to 300 mg using the capsule form. With rifampicin (rifampin on the US label) the efavirenz dose rises to 800 mg for patients of 50 kg or more. Elbasvir/grazoprevir is contraindicated. The label says nervous system symptoms are frequent, usually begin 1 to 2 days after starting and resolve in 2 to 4 weeks. Flag serious psychiatric symptoms, QTc prolongation and severe rash early, and monitor liver tests before and during treatment where there is underlying liver disease, including hepatitis B or C coinfection. Storage is 20 to 25 °C on the US label, with no special storage conditions on the UK SmPC, so no cold chain.
The documentation pack a regulator actually asks for.
Efavirenz is a room-temperature oral product. The US label gives 20 to 25 °C with excursions to 15 to 30 °C, and the UK SmPC states no special storage conditions. Key label warnings to carry into your specification: serious psychiatric symptoms, nervous system symptoms, QTc prolongation, hepatotoxicity, rash including severe rash, and the instruction not to use efavirenz as a single agent. On pregnancy the US label states: "Avoid administration in the first trimester of pregnancy as fetal harm may occur." The UK SmPC states that efavirenz should not be used during pregnancy unless the patient's clinical condition requires such treatment. The US label does not recommend efavirenz in moderate or severe hepatic impairment, and the UK SmPC contraindicates it in severe impairment (Child-Pugh C). For children, the UK SmPC says the film-coated tablets are not suitable under 40 kg, and the US dosing table uses capsules below 40 kg, so check the destination's label for paediatric presentations. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks. We state the source and status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.
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 efavirenz.
Dolutegravir
HIV-1 integrase inhibitor · antiretroviral therapy
Tenofovir disoproxil fumarate
Nucleotide reverse-transcriptase inhibitor · HIV-1 and chronic hepatitis B
Tenofovir + Emtricitabine
NtRTI + NRTI fixed-dose combination · HIV treatment and PrEP
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 efavirenz.
- 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.
Efavirenz supply, the specific questions.
What is the Sustiva generic name, and is a Sustiva generic available?
The generic name of Sustiva is efavirenz. In the US, DailyMed lists efavirenz tablet labels approved through the generic (ANDA) route from several companies, including Aurobindo, Cipla and Macleods, and an Aurobindo capsule label. The EMA lists Efavirenz Teva as a generic of Sustiva, authorised on 9 January 2012. The UK emc lists efavirenz 600 mg film-coated tablets under the efavirenz name, for example Efavirenz Milpharm. M Care also supplies Indian-made lines such as Efamat, Efcure and Estiva, and we do not describe them as registered anywhere unless the destination regulator says so.
Is Sustiva discontinued?
Drugs@FDA lists every Sustiva strength as discontinued: capsules of 50, 100 and 200 mg, and tablets of 300 and 600 mg, with a note that FDA found they were not discontinued or withdrawn for safety or effectiveness reasons. In the EU, the EMA page shows the Sustiva authorisation withdrawn on 1 February 2024 at the holder's request for commercial reasons. The Stocrin authorisation, a separate EU authorisation held by Merck Sharp & Dohme B.V., was withdrawn on 30 September 2025, also for commercial reasons. The EMA Sustiva page states that generic efavirenz medicines are authorised and marketed in the EU. A search of the UK emc for Sustiva returned no result.
Who is the Sustiva manufacturer, and what does the EMA page say?
Drugs@FDA lists Bristol Myers Squibb as the company for both Sustiva applications. The EMA page for Sustiva names Bristol-Myers Squibb Pharma EEIG as the marketing authorisation holder, with authorisation on 28 May 1999 and withdrawal on 1 February 2024. It covers HIV-1 antiviral combination treatment in adults, adolescents and children aged three years and older. The separate Stocrin page names Merck Sharp & Dohme B.V. as holder, also authorised on 28 May 1999, now withdrawn. Because both EU names are withdrawn, ask your tender desk whether the specification can accept another efavirenz product of the same strength.
Sustiva HIV: what is efavirenz used for, and what do buyers check on the label?
The US label lists efavirenz with other antiretrovirals for HIV-1 in adults and in children at least 3 months old who weigh at least 3.5 kg. It is never a single agent, and the label says not to add it as the sole agent to a failing regimen. Check the psychiatric and nervous system warnings, QTc prolongation, hepatotoxicity, rash, and the CYP3A and CYP2B6 interactions. The adult dose is 600 mg once daily on an empty stomach, preferably at bedtime. Pregnancy wording differs between the US label and the UK SmPC, so quote the destination's own label, not ours.
What decides the landed price of efavirenz for an importer?
We do not publish prices. The landed cost depends on whether you want an originator or regulator-registered brand or an Indian-made line, the presentation (600 mg tablet or capsule), the pack size, the quantity, the destination's registration route, freight and Incoterms. Efavirenz tablets need no cold chain, so freight is ambient. M Care Exports quotes per destination once you send the strength, volume and country.
How do efavirenz tablets fit programme procurement in Africa and the WHO Essential Medicines List?
The WHO electronic Essential Medicines List (eEML) lists efavirenz as a 600 mg tablet, and two fixed-dose combinations: efavirenz with emtricitabine and tenofovir at 600 mg + 200 mg + 300 mg, and efavirenz with lamivudine and tenofovir at 400 mg + 300 mg + 300 mg. We do not state treatment-guideline positions. Each country's programme sets its own specification and registration rules, and M Care Exports confirms the route per enquiry. For comparison with dolutegravir, tenofovir disoproxil fumarate or bictegravir with emtricitabine and tenofovir alafenamide, see their own pages, and compare on label facts only.
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.