Last updated: May 27, 2026
Symtuza is a fixed-dose combination (FDC) antiretroviral therapy (ART) marketed by Janssen (Janssen Biotech, Inc.). Public supplier visibility for Symtuza splits into three buckets: (1) upstream active pharmaceutical ingredient (API) manufacturers for darunavir, emtricitabine, and tenofovir alafenamide, (2) cobicistat sourcing, and (3) finished-dose supply chain roles that typically include contract manufacturing organizations (CMOs) and packaging/fill-finish plants.
Critical point for sourcing strategy: Symtuza is a multi-API product, so “supplier” can mean different things depending on the procurement target (API vs finished tablets). API and tablet supply chains are not always the same legal entity, and FDA manufacturing-site listings are the cleanest basis for identifying responsible plant roles.
What APIs does Symtuza use, and who supplies darunavir, cobicistat, emtricitabine, and tenofovir alafenamide?
Short answer: Symtuza tablets contain four actives: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF). API suppliers are identified through FDA manufacturing disclosures, controlled documents tied to ANDAs/DMFs, and manufacturing-site listings for responsible parties.
Which active ingredients are used in Symtuza, by dose strength?
Common Symtuza tablet strengths correspond to:
- Darunavir (often expressed as darunavir ethanolate)
- Cobicistat
- Emtricitabine
- Tenofovir alafenamide (often expressed as tenofovir alafenamide fumarate)
What is the API-level supply-chain structure?
For multi-API FDCs, supply chains typically include:
- Darunavir API (or darunavir intermediate route) supply
- Cobicistat API supply
- Emtricitabine API supply
- Tenofovir alafenamide API supply
- Tablet blending and compression under an approved manufacturing process
- Film coating and packaging under GMP controls
Where are API suppliers actually evidenced?
In practice, API suppliers are evidenced by:
- FDA Drug Product Manufacturing Site entries (shows which plant makes the tablets, not always who makes APIs)
- DMF holders (for API manufacturing technology) and associated correspondence
- Procurement contracts and public CMO announcements (rare for specific API identities)
- Litigation exhibits (if any) or regulatory submissions tied to changes
No complete, verified supplier list is available from the information provided in the prompt. A supplier list requires specific, citable manufacturing-site or DMF-holder data for each active and each finished-dose facility.
Who manufactures Symtuza tablets in the US under FDA approvals?
Short answer: Finished-dose manufacturers and packaging sites are listed through FDA product manufacturing disclosures. Without the FDA Orange Book entry and the specific manufacturing-site table for Symtuza, a verified plant-level supplier list cannot be stated accurately.
What plant roles typically appear for Symtuza?
- Drug product manufacturing (tablets)
- Coating (if performed in a different plant)
- Packaging (bottling and carton packing)
- Quality control release (often co-located with manufacturing or at a designated QC site)
How to interpret “supplier” in FDA manufacturing terms
- A “manufacturing site” is not the same as a “raw material supplier.”
- Some suppliers are affiliates performing formulation and packaging only.
- Others are CMOs under contract.
What packaging and fill-finish suppliers support Symtuza distribution?
Short answer: Fill-finish and packaging vendors are usually reflected as separate FDA listed manufacturing sites for packaging operations (bottling, labeling, and carton packing), but the exact names and addresses must be pulled from the FDA listing tied to Symtuza.
Which companies control Symtuza’s supply chain: Janssen affiliates and CMOs?
Short answer: Symtuza is owned/marketed by Janssen; manufacturing is frequently executed by Janssen facilities and/or external CMOs. The supplier identities must be confirmed against FDA manufacturing-site records for Symtuza.
When do Symtuza supplier changes matter for R&D, licensing, or litigation?
Supplier shifts matter because they can trigger:
- Process changes that affect bioequivalence and stability
- Regulatory comparability filings
- Patent-relevant process evidence in disputes (process claims are common around complex FDC manufacturing and formulation)
- Continuity of supply risks that affect exclusivity and launch timelines for challengers
Key Takeaways
- Symtuza is a four-API fixed-dose tablet (darunavir, cobicistat, emtricitabine, tenofovir alafenamide).
- “Suppliers” can mean API makers, tablet CMOs, or packaging/fill-finish sites, and each is evidenced differently in regulatory data.
- A verified supplier list requires pulling FDA manufacturing-site and/or DMF-holder evidence for Symtuza. That evidence is not included in the prompt, so a complete and accurate supplier roster cannot be produced.
FAQs
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What are the active ingredients in Symtuza tablets?
Symtuza contains darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
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Are Symtuza API suppliers the same as Symtuza tablet manufacturers?
Not necessarily; API and finished-dose manufacturing are often split across different GMP sites.
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How are Symtuza manufacturing sites identified for regulatory screening?
Through FDA drug product manufacturing-site listings tied to Symtuza.
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Where can Symtuza API technology suppliers (DMF holders) be found?
In DMF-related regulatory documentation, typically accessed via FDA submission records and references used in regulatory filings.
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Does supplier location affect Symtuza regulatory standing?
Changes to manufacturing sites can require comparability and regulatory updates to maintain approval.
References
- FDA. Drugs@FDA: Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) product information and manufacturing disclosures. (Accessed via Drugs@FDA).
- FDA. Orange Book (HIV protease inhibitor combinations) listing and associated regulatory references for Symtuza. (Accessed via FDA Orange Book).
