Suppliers and packagers for combivir

combivir

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857	NDA	ViiV Healthcare Company	49702-202-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18)	2010-10-19

Suppliers and packagers for combivir

Last updated: May 31, 2026

COMBIVIR drug suppliers: Who manufactures Combivir (lamivudine + zidovudine) and what supply risk exists?

Executive summary: COMBIVIR (lamivudine + zidovudine) is a fixed-dose combination antiretroviral (ARV) supplied globally by multiple branded-label and contract manufacturers over time. Current supply is fragmented by country, with formulations and labeling tied to local marketing authorizations and manufacturing sites. The supplier set is best determined by the country-specific product’s marketing authorization holder and the corresponding drug product manufacturing locations listed in regulatory filings and official label resources.

Who supplies COMBIVIR (lamivudine + zidovudine) in each market?

Featured answer: COMBIVIR supply is market-dependent. The practical “supplier” for procurement is the locally authorized marketing authorization holder or its appointed distributor, backed by the listed drug-product manufacturing site(s) on the approved product label or regulatory product database for that country.

How to identify the actual drug-product manufacturer for procurement

• Use the approved product label for the specific strength pack (typically tablet strength of the combination) in the target country.
• Confirm the listed manufacturer and manufacturing site on the label and in the associated marketing authorization documents.
• For hospital tenders, cross-check distributor and wholesaler chain in-country to avoid “label supply” being mistaken for “manufacturing supply.”

Where supplier visibility is usually highest

• EU: national competent authority product pages and EU product information, including manufacturer names and site addresses.
• UK: MHRA product details and label manufacturing information.
• US: if product exists in current labeling, FDA label/manufacturer listings and any Orange Book references tied to the specific NDA/ANDA.

Which companies manufacture COMBIVIR tablets (active ingredient suppliers and drug-product manufacturers)?

Featured answer: For fixed-dose combinations like COMBIVIR, “supplier” splits into two layers: API providers for lamivudine and zidovudine, and drug-product manufacturers that compress and package the combination tablet under the marketing authorization.

API vs finished-dose supplier

• API suppliers: produce lamivudine and zidovudine API (often via different chemical routes and sites).
• Finished-dose manufacturers: formulate, blend, compress, coat, and package COMBIVIR tablets, then release finished product.

Drug-product manufacturing typically tracked via

• Label manufacturer (drug product)
• Batch release site
• Packaging site
• Marketing authorization holder’s quality agreements and GMP release relationships

Does COMBIVIR have multiple manufacturers or one primary supplier?

Featured answer: COMBIVIR has historically been manufactured by multiple organizations across geographies, with site changes occurring through lifecycle management (line transfers, contract manufacturing, and label re-assignments). Market-specific labeling determines the effective supplier.

Common reasons supplier rosters change

• Contract manufacturing substitutions
• Site qualification and regulatory approval updates
• Packaging line changes
• Marketing authorization transfers between corporate entities

What is the Orange Book status of COMBIVIR and how does that affect supply?

Featured answer: Orange Book listings (where applicable) anchor exclusivity and generic reference mappings. Supply in the US depends on whether the reference/brand product remains marketed and whether any FDA-approved generic equivalents are active.

Implications for procurement

• If the brand is discontinued in a country, supply often shifts to generics with the same dose and comparable bioavailability.
• If the brand remains marketed, procurement still varies by distributor availability and local allocation.

What generic COMBIVIR equivalents exist and who supplies them?

Featured answer: COMBIVIR’s composition (lamivudine + zidovudine) has led to multiple equivalent combination tablet products in many markets, supplied by generic manufacturers and local distributors.

How to map “equivalent supply” to actual vendors

• Identify the marketed combination tablets by INN (lamivudine/zidovudine) and strength.
• Pull the specific local product label manufacturer for each strength.
• Validate formulation match by tablet strength and excipient profile when switching across suppliers for supply continuity.

Where is COMBIVIR manufactured and packaged for export?

Featured answer: Export supply is commonly sourced from one or more qualified manufacturing and packaging locations tied to the local marketing authorization. The exporter is usually the marketing authorization holder or its appointed supply partner.

Packaging and logistics dependencies

• Serialization or country-specific packaging rules can restrict vendor substitution.
• Cold-chain is not typically required for tablets, but humidity control and stability constraints still matter for shelf-life.

What supply risks exist for COMBIVIR (shortages, discontinuations, and tender constraints)?

Featured answer: Supply risk centers on market discontinuations and manufacturer site changes rather than inability to make the tablet chemistry. For procurement, the most actionable risk is a label-specific discontinuation or a sudden shift in the listed manufacturing site that disrupts qualification in hospitals.

Risk categories to watch

• Discontinuation of branded COMBIVIR in a given country
• Tender award locking to a specific label with a defined manufacturer
• Quality hold events tied to manufacturing site
• Regulatory variation: same dose, different tablet strength formats, or different packaging requirements

How does COMBIVIR compare with alternative lamivudine/zidovudine regimens for supply continuity?

Featured answer: Alternative ARV combinations or reformulations can reduce exposure to a specific brand supply chain. Procurement teams often switch to equivalent combinations where local supply is steadier.

Decision logic for continuity

• Evaluate whether comparable fixed-dose combinations (or separate dosing) are on stable supply
• Check local tender history for stockouts
• Compare label/manufacturer stability across 12 to 24 months

Key Takeaways

• COMBIVIR “suppliers” are market-specific and depend on the locally authorized product label, which names the drug-product manufacturing site(s).
• Finished-dose manufacturing supply is distinct from API supply for lamivudine and zidovudine.
• Orange Book status (when applicable) affects reference mappings and the generic landscape, but day-to-day procurement is driven by which labeled product is actively marketed and released locally.
• The highest practical supply risk is brand discontinuation and label-specific manufacturing site changes that complicate hospital qualification and tender approvals.

FAQs

1. How do I confirm the actual COMBIVIR manufacturing site listed for procurement in my country?
2. Are there supply substitutes to COMBIVIR using the same lamivudine plus zidovudine dosing?
3. What documentation do wholesalers typically provide for COMBIVIR batch release and manufacturer traceability?
4. Can I switch between different manufacturers of lamivudine/zidovudine tablets without changing dosing outcomes?
5. How do tender specifications usually handle manufacturer changes for COMBIVIR fixed-dose combinations?

References

1. European Medicines Agency (EMA). Product information for lamivudine/zidovudine fixed-dose combinations (as applicable by country marketing authorization).
2. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (as applicable to specific marketing authorizations).
3. UK Medicines and Healthcare products Regulatory Agency (MHRA). Product information and manufacturer listings (as applicable).