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Suppliers and packagers for tybost
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tybost
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094 | NDA | Gilead Sciences, Inc. | 61958-1401-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1) | 2014-09-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Tybost suppliers: active ingredient, dosage form manufacturing, and packaging sources
Tybost (cobicistat) is sourced through a small set of commercial-scale API and finished-dose supply chains, with final US availability tied to Gilead’s branded manufacturing partners and upstream suppliers for cobicistat synthesis, intermediates, and bottling/secondary packaging. The supplier map below covers the practical upstream roles that drive cost, supply continuity, and regulatory risk.
Who supplies Tybost (cobicistat) in the US market?
Answer: Tybost is supplied under Gilead’s branded commercial program. Upstream supply typically splits into (1) cobicistat API and key intermediates and (2) finished-dose manufacturing plus packaging and labeling for the marketed strengths (tablets).
API suppliers for cobicistat
Cobicistat is an HIV pharmacokinetic enhancer (CYP3A inhibitor). Commercial supply requires:
- A multi-step small-molecule synthesis with controlled chiral/impurity profiles
- Robust intermediate sourcing for stereochemically sensitive and impurity-controlled steps
- GMP release testing for API identity, assay, and genotoxic impurity limits
API supplier identity is typically disclosed via:
- US FDA facility listings tied to Tybost drug substance/drug product applications
- Contract manufacturing arrangements referenced in regulatory submissions
Finished-dose and packaging suppliers
Finished-dose supply includes:
- Tablet manufacturing (mixing, granulation, compression, film coating)
- In-process controls and tablet release testing (dissolution, uniformity)
- Bottling or blister packaging, labeling, and secondary packaging
These functions are generally performed by one or more contract manufacturers acting as Gilead’s drug product suppliers, with separate entities for packaging depending on distribution strategy.
What are the main Tybost supply-chain roles and what do suppliers do?
Answer: The Tybost supply chain is organized by API production, drug product manufacturing, and primary/secondary packaging.
Upstream: cobicistat API and intermediates
Key supplier responsibilities:
- Provide GMP-compliant cobicistat API
- Control impurity profile and genotoxic impurities
- Supply regulated intermediates used in cobicistat synthesis
- Maintain change-control documentation for process changes
Downstream: tablet manufacturing
Key supplier responsibilities:
- Produce cobicistat tablets at scale with validated manufacturing methods
- Maintain consistent dissolution and exposure profiles
- Perform stability testing for shelf-life establishment
Packaging suppliers
Key supplier responsibilities:
- Package to protect against moisture/light as required for stability
- Labeling aligned to NDC, strength, and lot tracking
- Supply chain traceability for recalls
Which FDA-registered facilities are linked to Tybost?
Answer: FDA-registered facilities for cobicistat tablet drug product and cobicistat drug substance are the controlling “supplier list” for compliance, because FDA approvals and inspections attach to specific sites.
The practical method to identify “the supplier” is to map:
- Drug substance manufacturing site(s) registered for cobicistat (API)
- Drug product manufacturing site(s) registered for Tybost tablets
- Packaging site(s) registered for dispensing unit labeling/packaging operations
Note: This analysis requires Orange Book and FDA facility inspection data to name specific legal entities. Without the Tybost-specific FDA facility listing for drug substance and drug product, the supplier names cannot be stated precisely.
How to identify Tybost suppliers for due diligence (contracting, CMO selection, risk)?
Answer: Due diligence should target site-level information, not just brand-level “manufacturer of record.”
Due diligence checklist for Tybost supplier identification
- Verify FDA drug substance and drug product facility registrations for cobicistat and Tybost tablets
- Obtain DMF/ASMF cross-references tied to cobicistat API where applicable
- Require evidence of GMP batch release capability for tablet strengths and packaging formats
- Confirm validated change-control history for API impurities and tablet dissolution
Supply continuity and business risk
For Tybost, supplier continuity is driven by:
- API process robustness and impurity management
- Tablet compression and dissolution performance sensitivity to formulation particle properties
- Bottling/blister line capacity and labeling lead times
What supplier constraints exist for cobicistat (Tybost) API?
Answer: The primary constraints for cobicistat API supply are impurity control, process validation stability, and regulatory acceptance of manufacturing changes.
Manufacturing and regulatory constraints
- Genotoxic impurity limits require strict intermediate purification and analytical capability
- Process changes can trigger comparability studies for tablets
- Cobicistat is a complex small molecule, so intermediate supply is often the bottleneck
How does Tybost supply compare with Genvoya, Stribild, and other cobicistat-containing products?
Answer: Tybost shares the same cobicistat active ingredient used in multiple Gilead HIV regimens, but supplier lists can differ because tablets are manufactured as separate drug products with different strengths, excipients, and packaging.
Implication for “who supplies”
- A cobicistat API supplier can be shared across programs
- Tablet/packaging CMOs can differ by NDC, strength, and distribution strategy
- Interactions between combination product demand and Tybost single-ingredient demand can tighten capacity
Key Takeaways
- Tybost is supplied under Gilead’s branded commercial program, with upstream cobicistat API sourcing and downstream tablet manufacturing plus packaging by specific GMP-registered facilities.
- The only compliance-grade “supplier list” is the FDA site-level registration mapping for cobicistat drug substance and Tybost drug product.
- Supplier risk concentrates in cobicistat API impurity control and tablet dissolution manufacturing controls, plus packaging line capacity and labeling lead times.
- For due diligence, verify site-level registrations, DMF/ASMF references, and GMP batch release capability rather than relying on brand-level marketing statements.
FAQs
- Which company manufactures the cobicistat API used in Tybost?
- What contract manufacturing sites produce Tybost tablets and package the NDCs?
- Are cobicistat API suppliers shared between Tybost and combination products like Genvoya or Stribild?
- How do supplier manufacturing changes affect Tybost quality and regulatory standing?
- What operational bottlenecks most often disrupt Tybost supply, API or tablet packaging?
References
- US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- US FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- US FDA. SPL (Structured Product Labeling) via DailyMed. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
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