Suppliers and packagers for TRIUMEQ PD

TRIUMEQ PD

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	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413	NDA	ViiV Healthcare Company	49702-258-37	1 KIT in 1 CARTON (49702-258-37) * 90 TABLET, FILM COATED in 1 BOTTLE (49702-272-59)	2022-03-30

TRIUMEQ PD suppliers: Who manufactures Triumeq PD components, DP/DS, and branded supply partners (US/EU)

Last updated: May 25, 2026

Triumeq PD is an antiretroviral fixed-dose combination product. Suppliers for “Triumeq PD” depend on the supply chain stage (API vs finished dosage form) and the geography (US vs EU).

Which companies supply TRIUMEQ PD ingredients (APIs) and key intermediates?

Triumeq (abacavir 600 mg + dolutegravir 50 mg + lamivudine 300 mg) is manufactured using three active pharmaceutical ingredients, each of which is typically sourced from specialized API suppliers under controlled DMF and drug master file relationships. For “Triumeq PD” specifically, the “PD” designation indicates a particular presentation/dosage form configuration, which changes the finished-dose manufacturing and packaging suppliers, but does not change the underlying three APIs (abacavir, dolutegravir, lamivudine).

API supply chain (typical structure)

• Abacavir API (and related intermediates) supplier(s)
• Dolutegravir API (and related intermediates) supplier(s)
• Lamivudine API (and related intermediates) supplier(s)
• Blending/granulation or direct compression excipient supplier(s) tied to the PD formulation
• Primary packaging material suppliers (bottles, caps, labels) and secondary packaging

Actionable procurement note Triumeq PD’s “ingredient suppliers” in practice are tracked through:

• FDA Drug Master File (DMF) holders for each API
• Orange Book and CMC manufacturer listings for the finished product
• EU medicines dossier/manufacturing authorizations (where applicable)

What are the FDA Orange Book and label-listed manufacturers for TRIUMEQ PD?

Featured snippet answer: The finished-dose manufacturer and packager of Triumeq PD are listed on the FDA label and Orange Book product record. Those entities are the legally relevant “suppliers” for clinical supply, wholesaler distribution, and generic-gap enforcement.

What to extract from Orange Book / label

• Applicant/holder (brand authorization holder)
• Manufacturer(s) listed for:
  • Drug substance (DS) manufacturing site(s), if listed
  • Drug product (DP) manufacturing site(s)
  • Packing and labeling sites
• NDA submission manufacturer references linked to CMC sections

Who manufactures TRIUMEQ PD in finished dosage form (DP) and handles packaging?

For antiretroviral fixed-dose combinations, DP manufacturing and packaging are often performed by:

• The NDA’s commercial manufacturer for tablets/capsules/powders matching the “PD” presentation
• One or more contract packagers for bottling, cartons, and label application
• Parallel sites for supply resilience during demand spikes

Procurement risk angle Packaging and label operations are a common constraint. When “PD” refers to a specific dosage form packaging configuration, the packaging site becomes part of the effective supplier list for any supply interruption or recall action.

Which contract manufacturing organizations (CMOs) and packaging partners support TRI UMEQ PD?

Triumeq fixed-dose combinations historically run through established global pharmaceutical CMO networks that have:

• Validated tablet manufacturing capability for multi-API regimens
• Controlled processes for potent integrase inhibitor APIs (dolutegravir)
• Regulatory-ready quality systems (GMP release, impurity control, traceability)

CMO and packager identities are confirmed through:

• Product label “Manufactured for” / “Distributed by”
• FDA facility listings tied to NDA and DMF references
• EU GMP certificate holders where the product is authorized

How do TRIUMEQ PD suppliers differ from Triumeq (non-PD) suppliers?

The “PD” presentation changes:

• The dosage form characteristics (or packaging configuration) and
• The DP and packaging manufacturing chain

It typically does not change:

• DS/API supplier relationships for abacavir, dolutegravir, and lamivudine
• The regulatory substance specifications tied to each API

What suppliers matter most for litigation, generics, and supply continuity for TRIUMEQ PD?

For IP and regulatory strategy, the legally and practically relevant “supplier” list is not just API makers. It is:

• The NDA drug product manufacturer and packager tied to the reference product
• DMF holders for each API (if you are mapping Paragraph IV design-around)
• Manufacturers of pivotal intermediates (if process patents exist)
• Sites named in FDA inspections and compliance actions

Supply chain map for TRIUMEQ PD (what to verify in records)

Below is the record-based checklist used to convert “who supplies” into defensible supplier lists.

Supply chain layer	Supplier types	Where to confirm
Abacavir API DS	API manufacturer / DMF holder	FDA DMF / CMC references
Dolutegravir API DS	API manufacturer / DMF holder	FDA DMF / CMC references
Lamivudine API DS	API manufacturer / DMF holder	FDA DMF / CMC references
Formulation components	excipients supplier(s) and co-manufacturers	CMC and commercial manufacturing disclosures
Finished dose (DP)	tablet/film-coat/powder compounding manufacturer	FDA label and Orange Book
Packaging and labeling	bottling/cartoning/labeling	FDA label and facility listings
Distribution	wholesaler and secondary distribution	label “distributed by”

When do TRIUMEQ PD supply contracts typically change?

Supply contracts and listed manufacturing sites change after:

• Commercial scale-up transfers to new CMO sites
• Equipment relocation or facility expansions
• Post-approval manufacturing changes (FDA supplements; EU variations)
• Quality events and lot-release constraints

These changes show up as:

• Updated facility listings in Orange Book and label
• FDA CMC supplement history linked to NDA manufacturing

Key Takeaways

• “Suppliers for TRIUMEQ PD” is best treated as a layered set: API DMF holders (abacavir, dolutegravir, lamivudine), finished-dose DP manufacturer, and packaging/labeling partners.
• The legally relevant supplier list for procurement, recalls, and regulatory submissions is the finished-dose manufacturer/packager listed on FDA product records and labeling.
• “PD” changes the drug product and packaging chain more often than the underlying API supplier relationships.

FAQs

1. Which FDA facility is the drug product manufacturer for Triumeq PD?
2. Who are the DMF holders for abacavir, dolutegravir, and lamivudine used in Triumeq PD?
3. Do Triumeq PD and Triumeq share the same packaging supplier?
4. What manufacturing sites are most likely to be impacted during a Triumeq PD recall?
5. How can generic applicants identify the correct reference product manufacturing and CMC references for Triumeq PD?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drug Labels (Triumeq PD product label). U.S. Food and Drug Administration.