WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Ziagen (abacavir) is a nucleoside reverse transcriptase inhibitor for HIV-1 infection in combination therapy, supplied as 300 mg scored tablets and a 20 mg/mL oral solution, with HLA-B*5701 screening required before starting.

M Care Exports supplies abacavir, including the originator Ziagen from ViiV Healthcare and Indian-made abacavir lines, to hospital pharmacies, HIV programme buyers, importers and tender desks in the GCC, Africa and the UK. If you are looking for abacavir 300 mg tablets or the 20 mg/mL oral solution, send the destination, the presentation and the quantity, and we quote per destination.

Ziagen 300 mg film-coated tablets pack (abacavir), ViiV Healthcare
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Abacavir exporter and bulk supplier from India.

"We need a partner for abacavir" is a typical enquiry from an HIV pharmacy or a tender desk. M Care is a merchant-exporter: we supply originator or regulator-registered brands and Indian-made lines, and we confirm which one your destination's registration route accepts before quoting. Ziagen is two products on the labels we read: a 300 mg tablet and a 20 mg/mL oral solution, packed separately, so a programme that needs both orders them as different lines. The US label lists bottles of 60 tablets and bottles of 240 mL of solution. The UK SmPCs list 60 tablets in foil blister packs and a 240 ml bottle of solution. Indian-made single-agent lines on our roster include A-Bec and Abamune 300 mg tablets. Abamune-L is a separate product on our roster and is quoted separately from single-agent 300 mg tablets. Neither the tablets nor the solution is a cold-chain product on the labels we read, which keeps freight simple. The quote turns on the pack, the quantity, the destination's registration route 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.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Nucleoside reverse transcriptase inhibitor (NRTI), synthetic carbocyclic nucleoside analogue, ATC J05AF06, sourced and documented for export.

The US label (ViiV Healthcare, DailyMed, revised 9/2023) describes abacavir sulfate as a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1, and indicates the tablets and oral solution, in combination with other antiretroviral agents, for the treatment of HIV-1 infection. The UK emc SmPCs list ViiV Healthcare UK Ltd for Ziagen 300 mg film-coated tablets and Ziagen 20 mg/ml oral solution, and give ATC code J05AF06 in the nucleoside reverse transcriptase inhibitor group. Adult dosing on the US and UK texts is 600 mg daily, given as 300 mg twice daily or 600 mg once daily. The WHO Model List (2023) has the entry abacavir, tablet: 300 mg (as sulfate), under nucleoside/nucleotide reverse transcriptase inhibitors, and the entry abacavir + lamivudine, tablet (dispersible, scored): 120 mg (as sulfate) + 60 mg, under fixed-dose combinations of antiretroviral medicines.

Active ingredient

Abacavir sulfate. Nucleoside reverse transcriptase inhibitor (NRTI), synthetic carbocyclic nucleoside analogue, ATC J05AF06.

Forms and strengths

300 mg scored film-coated tablet, 60 tablets per bottle or blister pack; 20 mg/mL oral solution, 240 mL bottle.

Indications

Abacavir is a nucleoside reverse transcriptase inhibitor used in combination with other antiretroviral agents for HIV-1 infection, supplied as 300 mg scored film-coated tablets and a 20 mg/mL oral solution. Supplied by M Care Exports as originator or regulator-registered brands and Indian-made lines, quoted per destination.

Administration

Oral. Film-coated tablet (scored) and oral solution.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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-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 abacavir 300 mg tablets for an HIV programme" or "We need a partner for abacavir oral solution for a paediatric tender". Each destination has its own registration or import route, for example the Emirates Drug Establishment (EDE) in the UAE and the MHRA in the UK, and we align the offer with it before quoting. M Care supplies both originator or regulator-registered brands and Indian-made lines, and confirms which your destination accepts. We do not claim Indian-made lines are registered in any destination. For programme buyers in Africa, the route depends on the destination regulator and the funder's own rules, and M Care Exports confirms it per enquiry.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on abacavir.

Treat abacavir as a screened-start medicine. The US label carries a boxed warning for serious and sometimes fatal hypersensitivity reactions with multiple organ involvement, and says all patients should be screened for the HLA-B*5701 allele before starting or restarting therapy, unless a previous HLA-B*5701 assessment is documented. It is contraindicated in HLA-B*5701-positive patients and in anyone with a prior hypersensitivity reaction. The UK SmPC says screening should be performed in any HIV-infected patient and abacavir should not be used in patients known to carry the allele. After a hypersensitivity reaction, never restart Ziagen or any other abacavir-containing product, and the UK SmPC names Kivexa, Trizivir and Triumeq as examples of abacavir-containing regimens. The US label also says a Medication Guide and Warning Card are dispensed with each new prescription and refill. Hepatic wording differs by text. The US label gives 200 mg twice daily for mild impairment (Child-Pugh Class A), using the oral solution (10 mL twice daily), and lists moderate or severe impairment as a contraindication. The UK SmPC says no definitive dose recommendation can be made for mild impairment and use is not recommended in moderate or severe impairment unless judged necessary.

Regulatory & quality

The documentation pack a regulator actually asks for.

Abacavir tablets and solution are not cold-chain products on the labels we read. The US label gives controlled room temperature of 20 to 25 °C for both, and says the oral solution should not be frozen and may be refrigerated. The UK SmPC for the tablets states do not store above 30 °C with a 3-year shelf life, and for the solution do not store above 25 °C with 2 years unopened and 2 months after first opening. The UK solution pack includes a 10 ml oral dosing syringe and a syringe adapter, and the SmPC lists sorbitol and propylene glycol among its excipients. Pack counts on the labels are 60 tablets per bottle (US) or foil blister pack (UK) and 240 mL per bottle. 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 claim that an Indian-made line is registered in your destination. The manufacturer's own certification, where a line has one, is stated by the manufacturer and not by M Care.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for abacavir.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Abacavir supply, the specific questions.

What is Ziagen 300 mg and what does the label say about it?

Ziagen 300 mg is a film-coated, scored tablet containing 300 mg of abacavir (as sulfate), from ViiV Healthcare. The US label indicates the tablets and oral solution, in combination with other antiretroviral agents, for the treatment of HIV-1 infection. Adult dosing on the US and UK texts is 600 mg daily, given as 300 mg twice daily or 600 mg once daily. The US label lists bottles of 60 tablets and the UK SmPC lists 60 tablets in foil blister packs. If you are looking for 300 mg tablets, send the destination, the quantity and whether you want the originator or an Indian-made line such as A-Bec or Abamune. M Care Exports quotes per destination.

Is there a Ziagen generic?

Yes, in the markets we checked. The UK emc lists Abacavir 300mg film-coated tablets from Aurobindo Pharma - Milpharm Ltd. and Abacavir Mylan 300 mg film-coated tablets from Viatris alongside Ziagen from ViiV Healthcare UK Ltd. In the US, DailyMed carries labels for generic abacavir tablets and oral solution from several labelers, including Aurobindo Pharma Limited and Mylan Pharmaceuticals Inc. We have not reviewed EU generic listings here, so check the regulator for your own market. M Care supplies originator or regulator-registered brands and Indian-made lines. Which one your destination accepts depends on its regulator, and we confirm it per enquiry. Abacavir is a synthetic nucleoside analogue, not a biological medicine, so the term biosimilar does not apply.

What is the Ziagen generic name?

The generic name is abacavir. The active ingredient on the labels is abacavir sulfate, and strengths are stated as abacavir, for example 300 mg tablets and 20 mg/mL oral solution. The UK SmPC gives ATC code J05AF06. Abacavir is also an ingredient in combination products such as Kivexa (abacavir and lamivudine) and Triumeq (abacavir, dolutegravir and lamivudine), both listed on emc, but those are distinct products with their own labels. Our Indian-made Abamune-L line is a separate product and is quoted separately from single-agent abacavir.

Does Ziagen come as an oral solution?

Yes. Ziagen oral solution is 20 mg/mL. The US label lists bottles of 240 mL and gives a paediatric dosage for patients aged 3 months and older of 8 mg per kg twice daily or 16 mg per kg once daily, up to a maximum of 600 mg daily. The UK SmPC lists a 240 ml bottle with a 10 ml oral dosing syringe and syringe adapter, storage not above 25 °C, 2 years unopened and 2 months after first opening. It lists sorbitol and propylene glycol among the excipients. The solution and the tablets are separate products and are ordered as separate lines. Send the destination and quantity and M Care Exports quotes per destination.

What are the Ziagen side effects?

The label's headline safety issue is hypersensitivity. The US boxed warning describes serious and sometimes fatal hypersensitivity reactions with multiple organ involvement, which have occurred in patients who do not carry HLA-B*5701, although carriers are at higher risk. The label says to discontinue Ziagen as soon as a reaction is suspected, and never to restart Ziagen or any other abacavir-containing product after a reaction. HLA-B*5701 screening comes before starting. The full list of adverse reactions is in the prescribing information for your destination, and we do not summarise it here. M Care supplies product and documents, not medical advice.

What drug class is Ziagen?

Ziagen is an antiretroviral in the nucleoside reverse transcriptase inhibitor (NRTI) class. The US label describes it as a nucleoside analogue HIV-1 reverse transcriptase inhibitor and abacavir sulfate as a synthetic carbocyclic nucleoside analogue, and the UK SmPC gives the pharmacotherapeutic group nucleoside reverse transcriptase inhibitors with ATC code J05AF06. It is indicated in combination with other antiretroviral agents. The WHO Model List (2023) lists abacavir, tablet: 300 mg (as sulfate), under nucleoside/nucleotide reverse transcriptase inhibitors. For how abacavir sits next to dolutegravir, efavirenz or tenofovir regimens, compare the labels. We do not recommend one product over another.

Sources and review

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.

Abacavir enquiry

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