Suppliers and packagers for Tivicay

Tivicay

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	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-226-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)	2016-06-09
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-227-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)	2016-06-09
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-228-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13)	2013-08-13
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-748-07	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07)	2013-08-13

Suppliers and packagers for Tivicay

Last updated: June 2, 2026

Tivicay (dolutegravir) Suppliers: Who Makes the API, Finished Drug Product, and Key Components

Tivicay’s supply chain splits across (1) dolutegravir active pharmaceutical ingredient (API) manufacturers, (2) finished-dose manufacturers for tablets, and (3) upstream excipient and packaging suppliers that appear indirectly via FDA manufacturing disclosures and commercial supply documentation. The most decision-relevant suppliers for licensing, contracting, and IP risk are the firms tied to FDA-registered manufacturing sites and listed in product and listing records.

Who supplies Tivicay (dolutegravir) tablets to the US market?

Tivicay (dolutegravir) is marketed in the US by ViiV Healthcare. The tablets are manufactured at FDA-registered sites for both dosage-form and, depending on the strength, with API sourced from specialized chemical synthesis and purification supply.

US product and manufacturing-site footprint

For US distribution, the binding suppliers are the FDA-registered manufacturing facilities tied to:

• Finished dosage form (tablet compression/coating, packaging)
• API manufacture (dolutegravir synthesis, isolation, and release)

In practice, this yields a “small set” of actionable suppliers because generic and challenger entrants must replicate the same API quality system under cGMP, even when the API is sourced from alternate plants.

Commercial supplier selection typically tracks FDA site registration

Supplier due diligence for Tivicay should focus on:

• FDA drug product listing manufacturing sites for Tivicay tablets
• Whether those sites list site-specific drug substance suppliers in registration records
• Whether the market uses multiple plants (to manage continuity of supply)

Which companies manufacture the dolutegravir API used for Tivicay?

Dolutegravir API manufacturing is typically concentrated among firms with established antiretroviral small-molecule capabilities, high-potency containment experience, and validated crystallization and polymorph control. Tivicay’s dolutegravir API supply is tied to ViiV Healthcare’s commercial supply arrangements and to FDA-registered sites.

API manufacturing considerations that affect supplier qualification

When evaluating an API supplier for dolutegravir, buyers typically screen for:

• Prior US regulatory inspection history for the API site
• Capability for high-purity controls (impurity profile and residual solvent limits)
• Batch-to-batch consistency for the active’s solid form
• Proven ability to support commercial scale and sustained supply

What excipient and packaging suppliers are used in Tivicay tablets?

Tivicay tablet supply uses standard pharmaceutical excipients and packaging systems that are selected to support:

• Chemical compatibility with dolutegravir
• Tablet compression and coating performance
• Stability and moisture protection
• Serialization and distribution integrity requirements

Where excipient and packaging sourcing shows up

Because excipient and packaging are often proprietary in commercial procurement, the supplier visibility most reliably comes from:

• Manufacturing record packages submitted to regulatory authorities (site-specific)
• NDA/BLA content references that name only excipient types rather than supplier identities
• Current Good Manufacturing Practice (cGMP) batch record specifications used by the dosage-form manufacturer

Are there multiple Tivicay tablet suppliers or only one plant?

Most large-volume oral antiretroviral programs use more than one manufacturing plant over the product lifecycle to manage:

• Capacity constraints
• Regulatory risk (site remediation or inspection outcomes)
• Supply continuity during technical transfers

How to verify plant multiplicity

Operational verification is typically done by mapping:

• Tablet strength specific manufacturing sites listed in US FDA references
• Labeling and distributor packaging traces across lots
• Changes in manufacturing site listings over time in FDA records

How does Tivicay supply change when strengths are introduced or line-extended?

Tivicay includes multiple tablet strengths. Supply chains can shift at strength-launch dates due to:

• Dose-specific formulation work
• Different tablet size and coating recipe needs
• Dedicated packaging presentation changes

Strength-to-supplier linkage

At line extensions, supplier relationships may change if:

• A new dosage-form plant is qualified for a particular strength
• API supply is re-sourced to meet volume forecasts
• Packaging format changes require requalification of distribution stability

Which vendors are involved in contract manufacturing for Tivicay?

Contract manufacturing is often split:

• Finished dose manufacturing may be performed by a dosage-form contract manufacturer under ViiV’s control or direct oversight.
• API manufacture may be performed by an API-focused chemical manufacturer with specialized reactors and isolation steps.

Due diligence target list

For contracting and licensing, the actionable vendor set generally includes:

1. Finished-dose manufacturing company at FDA-registered site(s)
2. Dolutegravir API manufacturing company at FDA-registered site(s)
3. Packaging and labeling operation at the distribution presentation stage

What does Tivicay’s supplier map imply for continuity-of-supply risk?

Supplier concentration raises two practical risk vectors:

• Single-site technical or inspection disruptions
• API supply interruption due to reactor downtime, solvent supply issues, or solid-form or impurity excursions

Mitigants used in antiretroviral supply chains

Companies manage continuity via:

• Dual sourcing of API plants
• Tech transfer qualification of alternative dosage-form lines
• Buffer stocks of API and critical excipients

How does Tivicay compare with other dolutegravir brands in supplier structure?

Dolutegravir’s competitive landscape includes other fixed-dose combinations and alternative presentations, which often share:

• The same dolutegravir API molecule
• Multiple API manufacturers capable of meeting the same specs
• Different tablet/combinational product formulation plants

Practical implication

If you map supplier structures for Tivicay and adjacent dolutegravir products, you can identify:

• Common API supplier overlap
• Shared contract manufacturing sites for oral solid dose
• Differing packaging and labeling vendors by product presentation

What patent and regulatory factors affect which suppliers can qualify?

Even when a contract manufacturer can produce tablets, regulatory eligibility hinges on:

• cGMP compliance at the manufacturing site
• Control strategy for dolutegravir and impurities
• Validation of dissolution, potency, and stability for the dosage form

Why IP matters to supplier qualification

Supplier qualification for any entrant depends on freedom-to-operate for:

• API synthesis methods (process patents)
• Formulation patents (tablet composition and release)
• Method-of-use patents (if relevant to claims)
• Regulatory exclusivities that delay generic or biosimilar entry

Key Takeaways

• Tivicay’s supply chain is anchored by FDA-registered manufacturing sites for dolutegravir API and tablet dosage form.
• The most actionable “suppliers” are the API and finished-dose manufacturing companies tied to those FDA-registered sites.
• Excipient and packaging suppliers are usually less directly visible, but are captured indirectly through the dosage-form manufacturer’s validated batch record specifications.
• Supplier concentration can create continuity risk, typically mitigated through dual-source API plants and multi-site dosage-form capacity.

FAQs

1. How do I identify the FDA-registered manufacturers for Tivicay tablets by strength?
2. Who supplies dolutegravir API for US-marketed Tivicay and how is API site diversity managed?
3. What manufacturing controls are critical for dolutegravir API suppliers to meet Tivicay specs?
4. Which documentation best supports supplier qualification for contract manufacturing of antiretroviral oral solids?
5. How can packaging and labeling supplier changes affect Tivicay distribution timelines and lot traceability?

References

1. US FDA. Drug Approvals and Databases: Drugs@FDA (Tivicay listings and manufacturing information). https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Tivicay entries). https://www.accessdata.fda.gov/scripts/cder/ob/
3. FDA. Drugs@FDA: Data standards and manufacturing-site references for human prescription drug products. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda