LAMIVUDINE AND ZIDOVUDINE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558	ANDA	Aurobindo Pharma Limited	65862-036-10	6 BLISTER PACK in 1 CARTON (65862-036-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2017-05-05
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558	ANDA	Aurobindo Pharma Limited	65862-036-60	60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60)	2017-05-05
Hetero Labs Ltd Iii	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079124	ANDA	Camber Pharmaceuticals, Inc.	31722-506-05	500 TABLET, FILM COATED in 1 BOTTLE (31722-506-05)	2015-09-18
Hetero Labs Ltd Iii	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079124	ANDA	Camber Pharmaceuticals, Inc.	31722-506-60	60 TABLET, FILM COATED in 1 BOTTLE (31722-506-60)	2015-09-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

Lamivudine and Zidovudine Suppliers: API and Finished-Dosage Supply Landscape, Key Manufacturers, and Sourcing Risks

Lamivudine and zidovudine are widely manufactured antiretroviral small molecules with a deep generic supply chain. Supplier selection is primarily constrained by (1) API quality systems and regulatory status (DMF/CEP), (2) ability to support finished-dose manufacturing and packaging for the specific country, and (3) IP and regulatory exclusivity that affect tendering and distribution windows.

Who manufactures lamivudine and zidovudine APIs globally?

The market is dominated by generic-capable API and intermediate manufacturers in India, China, and Europe, with additional capability among Western specialty API suppliers for certain grades and regulatory filings.

Lamivudine API manufacturing: typical supplier profiles

Common supplier types include:

API manufacturers with US DMFs and EU CEP pathways
Contract manufacturers supporting lower-cost grades for multi-source generics
Firms supplying key intermediates (e.g., nucleoside chemistry supply chain)

Zidovudine API manufacturing: typical supplier profiles

Common supplier types include:

API manufacturers with robust nucleoside GMP capability
Companies that supply both bulk drug substance and finished-dose contract manufacturing (tablet/capsule)
Intermediate suppliers supporting nucleoside and phosphorylation chemistry upstream

Major categories of supplier shortlists used in tenders

“US-facing” suppliers with US DMFs and established US inspection readiness
“EU-facing” suppliers with CEPs and EU GMP alignment
“ROW-facing” suppliers focused on local registrations and lower-cost tenders

What suppliers provide lamivudine and zidovudine finished dosages (tablets, capsules, combinations)?

Finished-dose availability depends on whether the market is:

Branded single-ingredient products
Generic single-ingredient products
Fixed-dose combination (FDC) or co-packaged regimens where procurement requires both actives to be harmonized in lead times, packaging, and labeling.

Key finished-dose supply chain constraints

Matching API supplier qualification and batch release acceptance criteria
Compliance with national pharmacopeia monographs and dissolution specs
Stability and shelf-life that are sensitive to excipient system selection
Serialization and country-specific packaging rules

Which companies are active API suppliers for lamivudine and zidovudine?

A practical sourcing approach for lamivudine and zidovudine is to build lists from:

FDA DMF holder rosters (US market access)
EU CEP holders and EMA-aligned quality pathways
Major generic API distributors and CMOs that publish validated manufacturing sites for nucleosides

At a business level, suppliers are typically evaluated on:

GMP track record for nucleoside APIs
Regulatory submission history for the target markets
Ability to deliver consistent polymorph and impurity profiles across batches

What is the Orange Book status for lamivudine and zidovudine in the US?

Lamivudine and zidovudine are long off primary-brand exclusivity in most jurisdictions. That dynamic typically enables multi-source generic competition and makes procurement more dependent on:

Quality and regulatory file fitness (DMF/ANDAs already approved)
Inspection readiness
Supply continuity and logistics reliability

(Orange Book listings are product-specific; bulk actives can be associated with multiple marketed finished dosage forms and strengths.)

Are there generic entry risks for lamivudine and zidovudine due to patents?

For these nucleoside reverse transcriptase inhibitors, generic entry risk is usually lower than for newer therapies, but not always zero at the finished-dose product level. Risks that still affect supplier award decisions include:

Narrow method-of-use or formulation patents tied to specific dosage forms or excipient systems
Country-specific secondary patents and enforcement
Litigation-driven tender delays for particular branded or higher-protection generics

Procurement impact generally concentrates on specific “supply lanes” (specific dosage strengths and labeling requirements), not on the actives broadly.

How do regulatory filings affect supplier qualification for lamivudine and zidovudine?

US pathway considerations

Supplier qualification for the US market typically hinges on:

US DMF status and ability to support relevant API standards
Consistent impurity and residual solvent controls
Ability to align with ANDA applicant requirements and batch documentation formats

EU pathway considerations

EU-facing sourcing often depends on:

CEP availability (or ability to support dossier-level data for registration)
Site GMP compliance and historical inspection outcomes
Batch release and stability evidence that matches local registration requirements

ROW pathway considerations

In many ROW tenders, buyers emphasize:

Local registration readiness
Consistent labelling and packaging
Reliable supply and lead-time performance

What manufacturing and IP barriers can block supply continuity?

For lamivudine and zidovudine, the core barriers are operational rather than fundamental chemistry IP:

Nucleoside GMP capacity constraints
Intermediate supply chain reliability for nucleoside-grade precursors
Batch-to-batch impurity control and analytical method robustness
Regulatory holds after deviations, not long-term patent blocks

Procurement teams typically manage these risks via:

Second-source qualification
Contractual lead-time buffers
Specification lock and change-control clauses

How does lamivudine compare with zidovudine suppliers in procurement availability?

Lamivudine typically shows broader supplier coverage due to higher historical utilization across many generic formulations globally. Zidovudine has similarly broad generic presence, but some markets can experience tighter supply for specific strengths, packaging, or co-formulated regimens.

In practice:

API supply breadth is usually not the binding constraint for either active.
The binding constraint is often finished-dose qualification, country-specific labeling, and packaging lead times.

What supplier selection criteria matter most for lamivudine and zidovudine?

For procurement and regulatory teams, the highest-leverage criteria are:

Regulatory file alignment (DMF/CEP and target market registration)
GMP site inspection posture and deviation history
Analytical capability for nucleoside impurities and polymorph/purity specifications
Capacity and lead time under demand spikes
Change control responsiveness (especially for excipients in finished doses)

Key supplier sourcing checklist (API and finished dose)

For API

DMF/CEP mapping to target countries
Impurity profile acceptance history
Batch analytical report format compatibility
Stability indicating method availability
Ability to support scale-up and commercial batch release

For finished dosage

Strength-specific manufacturing track record
Dissolution and bioequivalence-comparable dissolution strategy
Packaging component availability (blister materials, bottle systems, labeling stock)
Serialization/traceability support where required
Audit readiness for local inspections and buyer audits

Key Takeaways

Lamivudine and zidovudine have a mature global generic supply base; procurement is typically constrained by regulatory file alignment, GMP track record, and finished-dose qualification rather than by actives’ primary IP.
Supplier diversity exists, so multi-source strategies reduce continuity risk, especially when specific strengths or packaging are tendered.
The main due-diligence focus should be nucleoside-specific impurity control, regulatory dossier compatibility (DMF/CEP), and finished-dose stability and dissolution performance.

FAQs

1) What documents do buyers request from lamivudine and zidovudine API suppliers?
Usually batch COAs, GMP certificates, DMF or CEP references, impurity specifications, change-control history, and stability reports.

2) Can one supplier provide both lamivudine and zidovudine API under the same quality system?
Yes, but procurement should still qualify impurity and release acceptance separately for each active.

3) Are fixed-dose combinations of lamivudine and zidovudine subject to different supplier risk than single agents?
Yes, because finished-dose manufacturing, excipient system, labeling, and packaging create additional qualification and change-control dependencies.

4) What typically triggers delays in lamivudine and zidovudine supply continuity?
GMP deviations, impurity control failures, intermediate supply disruptions, and packaging component shortages are the most common operational drivers.

5) How do tenders usually evaluate lamivudine and zidovudine suppliers?
They prioritize registration readiness for the specific country, track record for batch consistency, lead time reliability, and audit readiness.

References (APA)

FDA. (n.d.). Drug Approval Reports: Search. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
EMA. (n.d.). European public assessment reports and related regulatory information. https://www.ema.europa.eu/en/medicines
FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

Suppliers and packagers for LAMIVUDINE AND ZIDOVUDINE