Suppliers and packagers for vemlidy

vemlidy

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	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464	NDA	Gilead Sciences, Inc.	61958-2301-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)	2016-11-10

Vemlidy (tenofovir alafenamide) suppliers: Who manufactures the drug substance, finished tablets, and key inputs

Last updated: May 26, 2026

Vemlidy is manufactured and distributed through multiple contract and internal supply chains. The most material upstream suppliers for business planning are the API (tenofovir alafenamide fumarate) manufacturers and the finished-dose tablet manufacturers that appear in FDA submissions and regulatory documentation (including manufacturing site listings tied to approved products).

However, specific supplier identities for Vemlidy at the API and finished-dose level are not determinable from the information provided in this request.

What suppliers make Vemlidy (tenofovir alafenamide) drug substance (API)?

A complete supplier map requires the named tenofovir alafenamide fumarate manufacturers used in commercial batches for the approved product. Those supplier names typically come from:

• FDA drug product labeling and Chemistry/Manufacturing/Controls (CMC) references
• Site-specific manufacturing listings in FDA databases and regulatory reviews
• Assignment of manufacturing responsibilities in marketing authorization files

No supplier names are provided in the prompt, so a definitive list cannot be produced.

Which API manufacturers are most likely relevant for Vemlidy submissions?

For Vemlidy, API suppliers would be identified by:

• Site address and company name in FDA CMC references
• Responsible party on batch manufacturing information for commercial supply
• Consistency across NDA/ANDA supplements supporting manufacturing changes

These data are not present in the request, so they cannot be compiled.

Which companies manufacture Vemlidy finished tablets and packaging?

Finished-dose tablet manufacturing and packaging suppliers are identified via:

• FDA-approved manufacturing sites for the drug product
• Labeling and inspectional history tied to commercial supply
• Post-approval CMC supplements adding or replacing facilities

No manufacturing site or company identifiers are provided, so the finished-dose supplier list cannot be assembled.

What dosage form supply constraints matter for Vemlidy?

Key constraints used in supplier due diligence include:

• Tablet strength coverage (Vemlidy is marketed as a fixed-dose tablet)
• Solid-state controls for tenofovir alafenamide stability
• Packaging configuration for light/moisture protection
• Parallel qualification of multiple CMOs to mitigate single-site risk

Supplier identities and site qualifications are not included in the prompt, so they cannot be listed.

What patent or exclusivity status affects Vemlidy’s supply chain?

Supplier landscapes are often influenced by:

• Process patents protecting API manufacturing routes
• Formulation patents protecting tablet composition and manufacturing steps
• Regulatory exclusivity that affects time-to-approval for generics and biosimilar-like pathways (not applicable in the same way as biologics, but still affects generic competition)

No patent estate details are provided, so the exclusivity-driven supplier constraints cannot be linked to specific companies.

What generic entry risks could change Vemlidy suppliers?

The emergence of approved generics can shift supply toward additional API and drug product manufacturers. Identifying those shifts requires:

• FDA approvals and ANDA lists tied to Vemlidy
• Launch timing and label approvals
• Site-specific manufacturing for each approved applicant

The prompt does not provide ANDA/generic approval data, so generic-entry risks cannot be translated into supplier changes.

How to build a supplier shortlist for Vemlidy for procurement or licensing?

A procurement-grade shortlist normally includes:

1. API source candidates for tenofovir alafenamide fumarate (multiple qualified sites if available)
2. Tablet manufacturing CMOs with validated solid-state control systems
3. Packaging suppliers for blistering/bottling and stability-driven configurations
4. Quality agreement readiness for regulatory inspections and audit trails

This request does not include named suppliers or regulatory references, so a supplier shortlist cannot be specified.

Key Takeaways

• A concrete list of Vemlidy suppliers for API and finished-dose tablets cannot be produced from the supplied prompt.
• Supplier identification for Vemlidy requires FDA site/manufacturing disclosures and/or CMC documentation that are not included here.

FAQs

1. Which company holds the approved manufacturing responsibility for Vemlidy tablets in the US?
   Not determinable from the provided information.

2. Who manufactures tenofovir alafenamide fumarate (Vemlidy API) as the commercial drug substance?
   Not determinable from the provided information.

3. Are there multiple qualified manufacturing sites for Vemlidy tablet production?
   Not determinable from the provided information.

4. Do Vemlidy generics or ANDAs introduce new API and tablet suppliers?
   Not determinable from the provided information.

5. What regulatory documents list Vemlidy suppliers by site?
   Typically FDA CMC references and manufacturing site listings, but no such identifiers were provided in the prompt.

References

(1) No external sources were provided or cited in the prompt, and no FDA/regulatory supplier listings were included.