Suppliers and packagers for generic pharmaceutical drug: cabotegravir sodium

cabotegravir sodium

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	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887	NDA	ViiV Healthcare Company	49702-248-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-248-13)	2021-01-21

CABOTEGRAVIR SODIUM Suppliers Landscape: API, Drug Substance Manufactures, and Finished-Dose Contract Options

Last updated: May 24, 2026

Cabotegravir sodium supply is concentrated in a small set of global API and key intermediate vendors, with finished-dose manufacturing commonly performed under branded supply chains for long-acting cabotegravir (CAB-LA) products. The most decision-relevant supplier categories are (1) cabotegravir API and (2) formulated drug product contract manufacturing for injectable dosing presentations.

Because “suppliers for cabotegravir sodium” can mean different procurement units (API vs intermediates vs sterile injectable drug product), the supplier map below is organized by procurement use case.

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What companies supply cabotegravir sodium API?

Direct API suppliers: Cabotegravir sodium is typically sourced through multinational API producers or specialty generics/ARV API manufacturers that maintain chemical process capability for integrase inhibitor scaffolds and can supply salts with validated polymorph and impurity profiles.

Common supplier patterns observed for CAB-LA supply chains

• API + key intermediate bundling: Many commercial supply models bundle cabotegravir and upstream intermediates to control impurity carryover (a key regulatory driver for ARV small molecules).
• Sterile formulation separation: Even when the same vendor sells API, the final long-acting injectable is usually manufactured by a separate sterile drug product CMOs network.

API supply due diligence checklist (what to verify in vendor qualification)

• Salt specification: cabotegravir sodium form, particle size/PSD, and hygroscopicity controls.
• Impurity profile alignment to drug substance specifications for the intended branded/regulated product.
• Residual solvent, heavy metal limits, and elemental impurities per ICH Q3D.
• DMF access or equivalent dossier support for regulatory filings.

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Which suppliers make cabotegravir key intermediates used to form cabotegravir sodium?

Cabotegravir sodium supply often relies on qualified intermediate producers upstream of the final API. Intermediate sourcing is typically structured around:

• high-potency heterocycle construction steps,
• purification and impurity control steps that drive final ARV impurity spec compliance,
• salt formation and crystallization steps to achieve cabotegravir sodium with the required solid-state attributes.

Intermediate supply chain procurement view

• If the API vendor cannot support impurity provenance, buyers typically qualify a second source or require explicit impurity impact studies for any process change.
• For long-acting injectables, solid-state consistency at the API stage matters because formulation performance can be sensitive to PSD and impurity load.

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What formulations use cabotegravir sodium and who supplies the sterile injectable drug product?

CAB-LA drug product context

• Cabotegravir sodium is used in long-acting injectable formulations (CAB-LA) delivered via sterile manufacturing, with strict controls for endotoxin, sterility assurance, and container closure integrity.
• Drug product supply is usually handled by a sterile injectables CMO with prior experience in long-acting depot formulations.

Drug product supplier selection criteria

• Sterile manufacturing capability for suspensions (if applicable to the specific marketed dosage form).
• Experience with depot or long-acting injectable systems.
• Ability to support batch record traceability for regulatory inspections.
• Packaging and secondary assembly aligned to distribution markets.

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Which companies contract manufacture long-acting cabotegravir (CAB-LA) injectables?

For procurement and licensing work, distinguish:

• API vendor: supplies cabotegravir sodium drug substance.
• Drug product CMO: manufactures and fills sterile long-acting cabotegravir injections.
• Fill-finish partners: may be separate from depot formulation.

Typical industry structure

• Formulation development can be linked to the innovator’s technical package, but commercial fill-finish is commonly done through qualified sterile manufacturing networks.
• Long-acting depots often require a CMO with validated aseptic suspension handling and depot stability data support.

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How does supplier concentration affect cabotegravir sodium availability and pricing?

Cabotegravir sodium is an ARV integrase inhibitor tied to long-acting branded supply. That typically produces:

• Fewer qualified commercial API sources than for shorter-acting generics.
• Long qualification timelines due to impurity control requirements, sterile drug product dependencies, and regulatory dossier linkages.

Pricing exposure drivers

• API scarcity and lead times during demand spikes for long-acting programs.
• Regulatory and inspection outcomes at API plants.
• Salt form variability and batch-to-batch consistency requirements for depot injectables.

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What alternative supplier routes exist if primary cabotegravir sodium vendors are constrained?

When primary sources are constrained, buyers typically pursue:

• Second-source API qualification with explicit impurity control alignment.
• Intermediate-level dual sourcing with tighter acceptance criteria for impurity carryover.
• Manufacturing process transfer only after establishing solid-state and analytical comparability for cabotegravir sodium.

Execution risk points

• Salt and crystallization process changes can trigger requalification needs.
• Impurity spikes can force rejection or rework, delaying batch release for sterile drug product.

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Which geographies produce cabotegravir sodium and where are manufacturing/IP barriers highest?

Cabotegravir sodium API production is concentrated in regions with established ARV manufacturing capacity and chemical process development capability. IP barriers and technical transfer friction are usually highest where:

• the supplier needs access to proprietary routes or detailed impurity targets,
• regulatory reliance is required on a specific dossier or DMF holder,
• the supplier lacks prior experience with long-acting injectable impurity sensitivity.

Procurement strategy implications

• For licensing or dispute-driven programs, buyers often prioritize suppliers with an established dossier history and inspection readiness.
• For emergency supply, buyers focus first on API supply continuity, then sterile drug product fill-finish readiness.

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Key Takeaways

• Cabotegravir sodium supply splits into two procurement layers: API (drug substance) and sterile injectable drug product manufacturing.
• Vendor qualification is driven by salt form control, impurity profiles, and sterile depot manufacturing constraints, which reduce the number of truly interchangeable suppliers.
• Supply continuity planning requires second-source API qualification and a separate sterile fill-finish plan to avoid bottlenecks.

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FAQs

1. Can a single supplier provide both cabotegravir sodium API and long-acting injectable drug product?
   In practice, this is uncommon; API and sterile depot fill-finish often come from different qualified entities.

2. What specs matter most for cabotegravir sodium when switching between suppliers?
   Solid-state attributes, PSD, impurity profile, residual solvents, elemental impurities, and salt confirmation.

3. What are the biggest bottlenecks in qualifying a new cabotegravir sodium supplier?
   Analytical comparability and impurity control alignment, followed by downstream drug product batch acceptance and regulatory documentation.

4. Do cabotegravir sodium intermediates have similar qualification rigor as the final API?
   Yes, because impurity carryover and process consistency propagate into the drug substance specs.

5. How do supplier changes impact long-acting cabotegravir injectable performance?
   Depot formulations can be sensitive to API particle characteristics and impurity load, affecting stability and release behavior, driving additional comparability work.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. EMA. (n.d.). European public assessment reports (EPAR). European Medicines Agency. https://www.ema.europa.eu/en/medicines
3. ICH. (2014). ICH Q3D: Guideline for Elemental Impurities. International Council for Harmonisation. https://www.ich.org/