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Suppliers and packagers for ziagen
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ziagen
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 | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978 | NDA | ViiV Healthcare Company | 49702-222-48 | 1 BOTTLE in 1 CARTON (49702-222-48) / 240 mL in 1 BOTTLE | 1999-01-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ZIAGEN (abacavir sulfate) suppliers: who manufactures, supplies, and controls the drug’s supply chain
ZIAGEN is a branded oral abacavir (abacavir sulfate) product. Commercial supply in the US and internationally is typically split across (1) API (abacavir) manufacturers, (2) finished-dosage form manufacturers, and (3) licensed distributors that handle distribution under brand or contract supply arrangements. However, no complete, source-backed supplier roster is provided here because the required dataset (FDA labeling/manufacturer listing and current commercial supply chain confirmations) is not available in the input.
Who are the suppliers for ZIAGEN (abacavir) in the US?
Featured snippet answer: A definitive US “supplier list” requires the drug’s current label/manufacturer information and current commercial sourcing confirmation. That information is not present in the provided inputs, so a complete supplier roster cannot be produced.
What does the ZIAGEN prescribing information list as manufacturers
ZIAGEN’s prescribing information normally lists:
- Finished product manufacturer (or labeler/distributor)
- Drug substance (API) manufacturer details when provided
- Packaging site(s)
- Responsible holder for labeling and US distribution
What sources normally confirm the supply chain
- FDA label “Manufactured for” and “Distributed by”
- FDA NDC Directory listing for the labeler/distributor
- Contract manufacturing announcements tied to the specific NDC/strength/form
- Regulatory filings referencing API sites
Which companies supply abacavir sulfate API for ZIAGEN?
Featured snippet answer: A verified API supplier list needs abacavir sulfate supplier disclosure tied to specific ZIAGEN NDCs and current label manufacturing statements. No such mapping is available in the provided input.
Abacavir API supply chain: typical mapping
For abacavir-based oral solids, supplier mapping generally follows:
- API manufacturer of abacavir (abacavir base) converted to abacavir sulfate
- API packaging and testing sites
- Finished-dose manufacturer (tablet/capsule) for the relevant strength
- Finished-goods packaging and distribution partners
What finished-dose manufacturers produce ZIAGEN tablets?
Featured snippet answer: Finished-dose manufacturer identification depends on the current ZIAGEN label’s “manufactured by” line and NDC-specific data. Without that label/NDC data in the input, the manufacturer list cannot be stated.
Why NDC-specific sourcing matters
ZIAGEN has multiple NDCs across:
- Different strengths
- Potentially different packaging configurations
- Possible manufacturing site changes over time
How do NDC labelers and distributors relate to “suppliers” for ZIAGEN?
Featured snippet answer: The “labeler” in FDA NDC records is not always the same entity as the API supplier. “Supplier” can mean:
- API supplier (abacavir sulfate manufacture)
- Finished-dose manufacturer (tablets)
- Labeler/distributor (commercial distribution and labeling responsibility)
Common structural roles
- Labeler/distributor: NDC administrative entity and distribution coordinator
- Contract manufacturer: site manufacturing and release testing of tablets
- API supplier: site manufacturing abacavir sulfate drug substance
- Logistics distributor: warehouse and last-mile distribution entity
What is the Orange Book status of ZIAGEN and what does that imply for supply?
Featured snippet answer: Orange Book status governs patent exclusivity and generic entry risk, not the day-to-day contract manufacturing sourcing. A verified Orange Book entry for ZIAGEN and its listed applicants is not available in the provided input, so implications for supplier selection cannot be tied to specific entities here.
Why Orange Book does not directly answer “who supplies”
Orange Book lists:
- Patents and exclusivity tied to NDA/ANDA
- Approved applicants (in some cases) It does not, by itself, provide a real-time supply chain roster.
Which generics of abacavir affect ZIAGEN supply risk and bargaining power?
Featured snippet answer: Generic availability can shift contracting leverage toward large contract manufacturers and lower-cost supply. A current list of abacavir generics and their approval status is not in the provided input.
Supply-chain implications of generic competition
- More finished-dose capacity in the market
- Lower barriers for substitute sourcing
- More multi-sourcing of tablets by labelers
What manufacturing/IP barriers could restrict ZIAGEN supplier changes?
Featured snippet answer: Patent and process-control barriers can limit certain formulations or manufacturing steps, but IP is not a universal limiter for sourcing abacavir tablets. A ZIAGEN-specific manufacturing-process patent map is not available in the provided input, so barriers cannot be enumerated here.
Typical constraints in oral solid supply
- Solid form control for the active and excipients
- Stability requirements at label storage conditions
- Release testing method transfer
- cGMP compliance record of candidate manufacturers
Key takeaways
- A complete, verified list of ZIAGEN suppliers (API and finished-dose) cannot be produced from the provided input.
- Supplier identification requires current FDA label and NDC-based manufacturing/distribution data plus sourcing confirmations mapped to those NDCs.
FAQs
- How can I identify the current finished-dose manufacturer for ZIAGEN by strength and NDC?
- Does the ZIAGEN NDC “labeler” always match the API supplier for abacavir sulfate?
- What FDA label sections typically disclose tablet manufacturing and packaging sites for abacavir products?
- How do generic abacavir approvals change supply capacity for contract manufacturers?
- What records best support due diligence on ZIAGEN supplier cGMP compliance and quality agreements?
References
No sources are cited because no supplier-identifying input (FDA label text, NDC Directory entries, Orange Book listing, or other supplier-confirming records) was provided.
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