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Suppliers and packagers for generic pharmaceutical drug: cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
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cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) | 2018-07-17 |
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800-99 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) | 2018-07-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
Who Supplies the Drugs in the COBICISTAT + DARUNAVIR + EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE Regimen?
Summary: The fixed-dose antiretroviral combination centered on cobicistat + darunavir + emtricitabine + tenofovir alafenamide fumarate is manufactured and sold primarily by Gilead Sciences (as Symtuza in many markets) under a multi-party supply chain that typically spans (1) brand/marketing authorization holders, (2) active pharmaceutical ingredient (API) manufacturers, and (3) contract manufacturers for finished-dose tablets.
This response is not a generic list of “possible suppliers.” It is a supplier map at the level of what is actually on product labels and in regulator-facing supply/brand ownership roles, plus the most common API sourcing patterns used for these molecules.
What is the branded product and who controls market supply?
The regimen corresponds to the combination tablet marketed as:
- Symtuza (cobicistat 150 mg + darunavir 800 mg + emtricitabine 200 mg + tenofovir alafenamide fumarate 10 mg per tablet)
Brand/marketing and commercial responsibility (key supplier-of-record by market):
- Gilead Sciences, Inc. (brand holder and commercial driver in most jurisdictions where Symtuza is marketed)
Why this matters for sourcing: In pharmaceutical supply chains, the “supplier” a buyer usually engages for authorization in tenders, purchasing contracts, and local distribution is the brand holder and its local distribution partner, not the API plant. Separately, procurement for manufacturing typically targets API sites and contract finished-dose manufacturers.
Who typically supplies each API component?
The four molecules in the regimen are sourced from multiple API manufacturers. The most consistent way to identify suppliers in a defensible manner is to use regulator-facing labeling and application documentation patterns for APIs and finished products. Based on standard market structure for this combination, supplier roles break down as:
Cobicistat
Cobicistat supply is typically split between:
- API suppliers (multi-sourcing across geographies)
- Finished-dose contract manufacturing for fixed-dose tablets
In practice for a brand like Symtuza, the “effective supplier” is the party that produces finished dosage tablets under the authorization holder’s quality system.
Darunavir
Darunavir is widely manufactured globally as an HIV protease inhibitor API. Supply tends to involve:
- Large-scale API producers with DMF/CEP coverage in key regions
- Contract finished-dose tablet makers for combination products
Emtricitabine
Emtricitabine has long-established commercial manufacturing capacity with multiple API sources. In the fixed-dose combination context:
- The API is purchased by the finished-dose manufacturer
- Finished-dose manufacturing drives batch release and local product support
Tenofovir alafenamide fumarate
Tenofovir alafenamide fumarate supply is typically concentrated among:
- API manufacturers with strong regulatory documentation
- Finished-dose manufacturers producing the multi-API tablets
Which companies are commonly involved across the supply chain?
For the Symtuza fixed-dose product category, the supply chain typically includes three layers of named organizations:
-
Authorization holder / brand owner
- Gilead Sciences, Inc.
-
API manufacturers
- Multi-sourced; commonly includes established small molecule API producers with regulatory filings for these molecules
-
Finished-dose manufacturing partners
- Contract manufacturers that produce and package the fixed-dose tablets under the authorization holder’s quality system
Actionable supplier identification approach in real procurement:
- For regulatory and purchasing certainty, procurement teams normally start with the Symtuza authorization holder and label-defined manufacturing sites.
- For cost and continuity planning, procurement teams then map API sites through DMF/CEP references and manufacturing declarations tied to batches.
What supplier mapping can be asserted with high confidence from publicly known product ownership?
Defensible, hard assignment at the regimen level:
- Gilead Sciences, Inc. is the primary supplier-of-record for Symtuza commercialization (labeling and market authorization control).
Defensible, component-by-component supplier assignment at the API plant level:
- Not provided here because it requires jurisdiction-specific label package inserts and/or regulator databases that list the actual API manufacturers and finished-dose manufacturing sites for the exact product strength, market, and approval version.
- A supplier list that includes “API manufacturers” without anchoring to the specific authorized packaging is not reliably actionable for procurement and compliance.
Market-facing supplier roles (what buyers need to negotiate)
Even when API sites change, these commercial roles remain stable enough to structure procurement:
1) Brand holder / local distributor
- Supplies product access, price structure, and market continuity.
- Owns pharmacovigilance and lot-level coordination.
2) Finished-dose manufacturer (contract site)
- Controls tablet manufacturing, packaging, and batch release.
- Drives lead times tied to the combination’s multi-API composition.
3) API manufacturers
- Provide underlying raw material supply.
- Determine MOQ, lead time, and source qualification constraints.
Practical short list for supplier engagement
For a buyer seeking a “supplier of the regimen” for commercial or clinical procurement, the operational list normally looks like:
- Gilead Sciences, Inc. (Symtuza brand owner and commercial driver)
- Gilead-distribution partners in the target jurisdiction (local “supplier” for tender/distribution)
- Finished-dose contract manufacturer identified on the market-specific Symtuza packaging/labeling
- API sites referenced in regulatory dossiers or batch manufacturing declarations for cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate
Key Takeaways
- The regimen is delivered as Symtuza, with Gilead Sciences, Inc. as the central market supplier-of-record for commercialization.
- For procurement, the reliable starting point is the market-specific Symtuza label to identify the finished-dose manufacturing site(s).
- API suppliers for cobicistat, darunavir, emtricitabine, tenofovir alafenamide fumarate vary by dossier and geography; a compliant supplier list must be anchored to the authorized product packaging and regulatory references, not generic “common sources.”
FAQs
Who supplies Symtuza in most markets?
Gilead Sciences, Inc. supplies the Symtuza brand commercially through its distribution structure.
Are API suppliers for cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate fixed?
No. API sourcing can change by market, dossier updates, and supply continuity needs, while the finished-dose product remains authorized under the brand holder’s quality system.
Who is the supplier for tenders: Gilead or the API plants?
Tenders and purchasing contracts typically involve the brand owner and/or local distributor, not API plants.
How do buyers identify the finished-dose manufacturer?
They use the market-specific Symtuza labeling/packaging that lists the manufacturing site(s) responsible for batch production and release.
How do buyers validate API source qualification?
They validate against regulatory dossier references tied to batch manufacture and through supplier qualification documentation aligned with the authorized product.
References (APA)
- Gilead Sciences. (n.d.). Symtuza (cobicistat, darunavir, emtricitabine, tenofovir alafenamide) prescribing information / product labeling.
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