retrovir: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655	NDA	ViiV Healthcare Company	49702-211-20	100 CAPSULE in 1 BOTTLE (49702-211-20)	2010-10-28
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951	NDA	ViiV Healthcare Company	49702-213-26	5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) / 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)	2010-11-04
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910	NDA	ViiV Healthcare Company	49702-212-48	240 mL in 1 BOTTLE (49702-212-48)	2010-10-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Executive summary: Suppliers for RETROVIR (brand for zidovudine; AZT) split into two layers: (1) zidovudine API producers that feed the market and (2) finished-dose manufacturers that hold the labeling supply chain in each market. Because RETROVIR is an established, legacy HIV product and the U.S. brand is largely off the contemporary procurement route in many geographies, supplier visibility is driven by authorized generics and local distributors rather than exclusive brand procurement. This profile maps the supplier types and the practical supply risks relevant to R&D, licensing, and generic entry.

Which companies supply zidovudine (AZT) API used to make RETROVIR?

Featured answer: Zidovudine API is supplied by multiple chemical manufacturers globally; in many jurisdictions, the supply chain is dominated by generic API makers and contract manufacturing organizations that qualify under drug master files (DMFs) or directly under the receiving finished-dose site’s regulatory system.

API supplier categories for zidovudine

API manufacturers (DMF holders or non-DMF suppliers)
- Produce zidovudine with defined impurity and polymorph controls.
- Provide CoA/IMS, regulatory documentation, and audit support for finished-dose qualification.
Intermediates and upstream chemical suppliers
- Supply key intermediates that reduce the cost of goods for zidovudine.
- Often feed multiple API plants, which can create shared contamination risk and correlated quality events.
Global CMOs that package API into drug substance supply
- Some entities handle drying, milling, blending, and packaging to spec even if they do not synthesize the API end-to-end.

What drives API sourcing for zidovudine?

Impurity profile and control strategy (synthesis residuals, genotoxic impurities where applicable, and solvent residuals).
Solid-state control (particle size distribution and handling stability).
Regulatory footprint (DMF availability for receiving sites, inspection history, and audit outcomes).
Cold-chain not required, but packaging integrity and humidity control matter for long shelf-life.

Which manufacturers make finished RETROVIR (zidovudine) capsules and oral solution?

Featured answer: Finished-dose supply is typically executed by authorized generic and generic finished-dose manufacturers, with legacy brand supply in some markets. In practice, the “RETROVIR supplier” is usually identified by ANDA-labeled products selling under local brand labels or as direct generic equivalents.

Finished-dose dosage forms to track

Oral capsules/tablets (oral solids)
Oral solution (liquid)
Pediatric dosing formulations where applicable (historically common for AZT regimens)

Finished-dose supply chain structure

API is typically sourced from a qualified zidovudine API producer (often DMF-based).
The finished-dose site then manufactures tablets/capsules or solution, packages, and releases to distributors.
Quality systems for older molecules often rely on comparative impurity specs, process validation, and ongoing stability under market-specific packaging.

What is the best way to identify RETROVIR suppliers by market (US, EU, UK, etc.)?

Featured answer: Supplier identification is market-specific and is best done via regulatory product listings (e.g., FDA approval/labeling records, EU/UK product registers) combined with wholesaler/distributor catalogs used by procurement.

US supplier identification path

Track the FDA-listed product for zidovudine and any therapeutically equivalent oral solid/liquid products.
Cross-check with labeler/manufacturer listed on the package and in regulatory databases.

EU and UK supplier identification path

Use national product registers and EMA national marketing authorization records.
Identify manufacturer of record at launch and during line-extensions (solution vs capsule).

Does RETROVIR supplier supply depend on DMFs for zidovudine?

Featured answer: Yes in most practical cases. Receiving manufacturers typically qualify zidovudine API through a DMF or through direct technical agreement supported by regulatory-ready documentation and inspection outcomes.

How DMFs affect supplier switching

If the receiving finished-dose manufacturer depends on a specific DMF holder’s impurity control package, switching API suppliers can require:
- new qualification lots,
- stability bridging,
- regulatory updates to the drug master documentation,
- additional comparability work if impurity limits or particle size change.

When do RETROVIR supply constraints show up, and how are they mitigated?

Featured answer: For zidovudine, constraints are usually driven by API plant capacity, quality events, and regulatory inspection readiness, not by specialty delivery hardware.

Common supply disruption triggers

API plant downtime
Sterile or nonsterile manufacturing changes for the finished dose
Packaging component shortages (bottles, caps, child-resistant closures)
Audit findings that force de-qualification or requalification

Mitigation strategies procurement teams use

Dual sourcing of zidovudine API and excipient blends.
Qualified alternate manufacturing sites for the finished dose.
Multi-lot forward scheduling tied to stability windows.

What regulatory and quality barriers affect switching RETROVIR suppliers?

Featured answer: Finished-dose supplier switching is constrained by FDA/EU release controls, validated processes, and stability data rather than by the chemistry itself.

US and EU quality dependencies

Process validation and comparability for:
- dissolution profile (for solids),
- viscosity/osmolality and dose uniformity (for solution),
- preservative system (for solution products if used),
- container-closure compatibility.

Practical documentation that receiving sites require

CoA format alignment
impurity mapping and control strategy
extraction/analysis method equivalency
traceability for batch records and change controls

Which excipients and packaging suppliers matter for zidovudine oral solutions?

Featured answer: For liquid AZT formulations, excipients and container-closure systems can be major switching barriers.

High-impact components

Viscosity agent systems (when used)
Buffering agents to maintain pH range
Preservatives if the formulation requires them
Solubilizers/co-solvents as defined by the labeled formulation
Bottle type, liner material, cap seals, and closure torque specifications

How does RETROVIR generic entry affect supplier dynamics?

Featured answer: Generic entry shifts purchasing away from any legacy brand-centric supplier toward ANDA-labeled manufacturers and their qualified API suppliers, which increases supplier diversity but can also concentrate quality risk when multiple finished-dose sites rely on the same API producer.

Supplier concentration risk

If multiple generic finished-dose makers source API from one or two plants, a quality event at the API site affects the whole segment.

Contracting outcome

Procurers often negotiate:
- multi-source qualified vendors,
- minimum purchase commitments,
- and audit rights to maintain quality parity.

Key Takeaways

RETROVIR (zidovudine) supply is best analyzed through API producers plus finished-dose manufacturers and the DMF or qualification pathway that connects them.
Supply switching is less about the molecule and more about qualification, stability, impurity controls, and container-closure compatibility, especially for oral solution.
Generic market structure typically means the “RETROVIR supplier” question resolves into authorized generics and labeler/manufacturer records by geography, not a single global brand supply chain.
The biggest operational risk is often API plant concentration, where multiple finished-dose suppliers share the same underlying API source.

FAQs

1) How can procurement teams confirm zidovudine API supplier identity for a specific lot?
By validating lot CoA traceability, DMF/qualification linkage, and batch documentation against the finished-dose manufacturer’s approved supplier list.

2) What drives cost differences between zidovudine API and finished-dose suppliers?
API quality control costs, DMF/qualification status, stability and bridging requirements, and packaging component availability for capsules vs oral solution.

3) Are there formulation-specific supplier barriers for zidovudine oral solution versus capsules?
Yes. Oral solution requires tighter control of excipients, pH, dose uniformity, and container-closure compatibility versus solids’ dissolution and particle property controls.

4) Do zidovudine API supplier changes trigger regulatory reporting?
Typically yes for finished-dose manufacturers, depending on the change impact on impurity profile, dissolution, stability, and the regulatory filing structure used.

5) What causes most supply disruptions for legacy HIV oral drugs like zidovudine?
API plant outages and quality/audit events, followed by packaging component constraints and requalification timelines.

References

No sources were cited because no specific supplier company list, regulatory listing, DMF holder, or market register was provided in the prompt.

Suppliers and packagers for retrovir

retrovir

Suppliers for the Pharmaceutical Drug RETROVIR (AZT): Active Ingredient, Finished-Dose Manufacturers, and API/IP Supply Risks