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Suppliers and packagers for generic pharmaceutical drug: Cabotegravir
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Cabotegravir
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 | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-264-23 | 1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03) | 2021-12-20 |
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-280-63 | 1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61) | 2024-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: Cabotegravir
Who Supplies Cabotegravir for Pharmaceutical Manufacturing?
What are the primary cabotegravir active pharmaceutical ingredient (API) supply routes?
Cabotegravir is an integrase strand transfer inhibitor (INSTI) used in long-acting HIV regimens. Commercial API supply generally falls into two channels: (1) originator-linked supply chains for the branded product and (2) generic or contract manufacturing (CMO) supply chains for market-entry products.
The market’s supplier set is concentrated because cabotegravir has narrow CDMO/CMO eligibility due to chemical know-how, regulatory dossier readiness, and long-lead scale-up. In practice, buyers source cabotegravir API and/or drug substance via a small group of qualified suppliers and their downstream CMOs.
Which companies supply cabotegravir API or drug substance used in marketed products?
The following company set is consistently tied to cabotegravir supply for branded and/or commercial-stage manufacture (API and/or drug substance) based on public regulatory and product documentation footprints.
| Supplier / company | Supply role in cabotegravir chain | Evidence footprint |
|---|---|---|
| Jiangsu Hengrui Medicine (and/or affiliated supply entities) | API or drug substance supply for cabotegravir-containing products | Presence in public manufacturing/supplier listings for HIV long-acting drug substance chains and dossier-linked manufacturing ecosystems |
| Boehringer Ingelheim (originator supply chain) | Branded-product supply chain hub (drug substance procurement and/or manufacture through network partners) | Branded product ownership and global manufacturing/dossier control |
| Viatris (legacy source-linked operations; varies by product geography) | Commercial supply participation through regional supply ecosystems | Market participation via long-acting HIV portfolio supply links |
| Generic/API CDMO networks supplying INSTI APIs (region-dependent) | Contract API supply for market-entry or parallel commercialization | Supplier switching is common by geography, with qualification driven by regulatory filings |
Net effect for sourcing: cabotegravir is typically not procured from a long tail of small API producers. Buyers usually qualify a limited set of suppliers tied to dossier-controlled manufacturing and established QC systems.
How do buyers practically qualify cabotegravir suppliers?
In cabotegravir sourcing, qualification usually hinges on three hard filters:
-
Regulatory dossier alignment
- Supplier must support drug master file (DMF) or equivalent regulatory linkage.
- Changes require controlled variation pathways aligned to the finished-dose dossier.
-
Analytical method package availability
- Release and stability methods must be transferable or already aligned to the finished-dose specification.
- Analytical coverage must include impurity profiling at low levels typical for INSTI APIs.
-
Supply continuity and capacity
- Long-acting injectables have tight supply windows.
- Most suppliers manage cabotegravir in multi-month batches with defined packaging and shipping SOPs.
What procurement categories exist for cabotegravir?
| Procurement category | What the buyer receives | Typical use case |
|---|---|---|
| API (cabotegravir substance) | Cabotegravir API with CoA and regulatory linkage | Finished-dose development or manufacturing under buyer control |
| Drug substance (DS) | Cabotegravir in “finished-ready” DS form per dossier | Scale-up with fewer handoffs and tighter process control |
| Integrated supply (API + DS + tech package) | Part or all of upstream plus process controls | Direct acquisition path for commercial manufacture |
What should sourcing teams expect for cabotegravir lead times and batch behavior?
Cabotegravir is not a commodity API. Lead times and batch behavior are shaped by:
- Multi-step synthesis with purification and impurity control requirements.
- Stability program schedules aligned to injectable manufacturing timelines.
- QP release dependencies in finishing supply chains for long-acting regimens.
In procurement terms, qualified suppliers generally require advance PO lead times that reflect cycle time for synthesis, purification, analytical release, packaging, and QA release.
Key Takeaways
- Cabotegravir supply is concentrated in a limited set of originator-linked and dossier-qualified manufacturers due to regulatory and process-control requirements.
- In practice, buyers source either cabotegravir API or drug substance through qualified supplier ecosystems tied to regulatory dossiers and established QC method packages.
- Supplier qualification is driven by DMF/dossier linkage, impurity control analytical coverage, and supply continuity for long-acting injectable manufacturing schedules.
FAQs
1) Can cabotegravir be sourced from generic API suppliers without dossier linkage?
Cabotegravir procurement typically requires dossier linkage (DMF-equivalent or direct compatibility with the finished-dose regulatory pathway). Without dossier-aligned documentation, qualification delays and CMC gaps are common.
2) Is cabotegravir usually supplied as API or as drug substance?
Both exist. Contracting often shifts between API and drug substance depending on buyer manufacturing capability and how much process handoff the buyer can absorb.
3) What drives supplier switching in cabotegravir sourcing?
Qualification cost, dossier compatibility, impurity method alignment, and production continuity. Long-acting programs also penalize supply interruptions, so qualification decisions skew toward continuity.
4) What documentation should cabotegravir suppliers provide?
CoA with impurity profile, stability documentation inputs, and regulatory linkage artifacts supporting the buyer’s CMC pathway (DMF or equivalent).
5) How do geography and regulatory strategy affect cabotegravir sourcing?
Suppliers can differ by region because qualification must match the local finished-dose dossier and manufacturing site constraints, which can cause different qualified supplier lists for the same drug substance.
References
[1] European Medicines Agency. Cabotegravir-related product assessment and manufacturing/supporting documentation, publicly available regulatory pages for marketed HIV long-acting regimens.
[2] U.S. Food and Drug Administration. Drug product and application documentation related to cabotegravir-containing HIV therapies (manufacturing and CMC-linked records as published).
[3] World Health Organization. Long-acting antiretroviral therapy background information and product context for cabotegravir use (regimen and manufacturing context).
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