Suppliers and packagers for juluca

juluca

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	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192	NDA	ViiV Healthcare Company	49702-242-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)	2017-11-21

JULUCA Suppliers: Who Manufactures and Supplies Dolutegravir/Rilpivirine for US and Global Markets

Last updated: May 24, 2026

JULUCA (dolutegravir + rilpivirine) is supplied as a fixed-dose combination tablet and relies on a vertically coordinated supply chain spanning API manufacture, tablet formulation, and finished-dose packaging for global distribution. The supplier landscape is primarily driven by (1) the originator’s commercial manufacturing network and (2) contract manufacturing organizations (CMOs) used to scale fixed-dose combination production.

What suppliers provide the active ingredients and finished tablets for JULUCA?
The practical supplier question breaks into four layers: dolutegravir (DTG) API, rilpivirine (RPV) API, fixed-dose tablet formulation/tablet press, and packaging/release for different regions.

1) What companies supply JULUCA’s dolutegravir (DTG) API and rilpivirine (RPV) API?

JULUCA combines DTG and RPV, with the API supply chain typically anchored by companies that control proprietary synthesis routes or qualify as permitted API sources under the originator’s quality system.

H3: DTG API supply model for fixed-dose combinations

• DTG is commonly sourced through a small set of qualifying API manufacturers with scale capability.
• For combination products, API suppliers must support repeatability, impurity profiles, and regulatory documentation aligned to the finished-dose registration.

H3: RPV API supply model for fixed-dose combinations

• RPV API supply also depends on qualified manufacturing capacity.
• RPV’s impurity and polymorphic control requirements affect which API sources are acceptable for finished-dose batch release.

2) Who manufactures JULUCA tablets (fixed-dose combination) and where are they made?

For a fixed-dose combination like JULUCA, the key commercial supplier is the firm that produces and releases finished tablets under the originator’s quality agreements. Finished-dose manufacturing is usually handled by one primary site plus at least one backup site to ensure supply continuity.

H3: Finished-dose manufacturing steps that determine the “supplier”

• Drug product manufacturing (blending, granulation if used, compression/film coating)
• In-process controls and batch release testing
• Primary packaging and secondary packaging
• Serialization and regional labeling supply (US vs. EU vs. other markets)

H3: Tablet packaging and distribution suppliers

• Even when manufacturing is done by a dedicated drug product site, packaging and distribution can involve additional contract facilities.
• For US supply, drug product distribution is tightly coupled to FDA release workflows and wholesaler/DSCSA logistics.

3) What is the Orange Book status of JULUCA and which parties are tied to the listed manufacturing/labeling?

Orange Book listings generally identify the NDA holder and sometimes the labeled/recognized manufacturing entities associated with the registered product, which is the fastest way to map “regulatory suppliers” for the US market.

H3: How Orange Book listings identify responsible suppliers

• NDA holder: entity responsible for regulatory compliance and product submissions.
• Listed drug product: reference to the approved formulation.
• Patents and exclusivity: affects entry timing for generics and impacts the competitive supply pipeline.

4) What generic or biosimilar risks change the JULUCA supply landscape?

JULUCA is a small-molecule combination (not a biologic), so the competitive threat is generic small molecules via ANDA. Supplier risk shifts in two ways: (1) originator manufacturing capacity and (2) contract manufacturing capacity for generic entrants.

H3: Paragraph IV and ANDA-driven supply changes

• Where Paragraph IV challenges exist, they can prompt settlement agreements that include supply commitments or exclusivity-based arrangements.
• These deals can affect which CMOs get pulled into the contested supply chain.

5) Which countries’ suppliers matter most for JULUCA commercial supply?

JULUCA’s supply is typically multinational, with finished-dose and packaging operations placed in jurisdictions that support consistent GMP supply.

H3: Geographic mapping of suppliers

• US: originator-controlled release and DSCSA-compliant distribution.
• EU/UK: parallel supply via batch release aligned to local regulatory structures.
• Emerging markets: often depends on contract release capacity and trade logistics.

6) How to identify the “real” supplier list for JULUCA: a procurement-grade checklist

For procurement and due diligence, the supplier list should be built from three non-overlapping evidence streams:

H3: Regulatory evidence

• Orange Book NDA holder and listed manufacturing/labeling details
• FDA prescribing information “Manufactured for” and “Distributed by” statements

H3: GMP evidence

• Site names and capabilities from drug master file (where referenced) and inspection histories
• Quality agreements for API and drug product release testing

H3: Commercial evidence

• Label claims, distribution channel disclosures, and procurement documents from distributors/wholesalers

7) JULUCA supplier landscape for licensing and contract manufacturing

Fixed-dose combination products require tight integration between API and drug product manufacturing. Any supplier onboarding should address:

• API impurity specification match and hold-time/transfer validation
• Change control governance for synthesis and drug product process
• Regulatory file support for batch-specific release and comparability

Table: JULUCA supplier mapping framework (procurement-ready)

Supply layer	What you need to identify	Typical evidence	Why it matters
DTG API	Qualified API manufacturer(s) and sites	Regulatory references, DMFs/label references, GMP data	Impurity profile and synthesis control
RPV API	Qualified API manufacturer(s) and sites	Regulatory references, GMP data	RPV-specific impurity/polymorph control
Drug product	Finished tablet manufacturing sites (NDA-linked)	Labeling/manufactured-for statements, regulatory filings	Batch release and supply continuity
Packaging/release	Primary and secondary packaging sites; release testing	Labeling/distribution statements; DSCSA data where accessible	Regulatory compliance and traceability
Distribution	Wholesaler/distributor network	Prescribing info, distribution contracts	Availability and service levels

Key Takeaways

• JULUCA’s supply chain is best understood as a four-layer stack: DTG API, RPV API, finished-dose tablet manufacturing, and packaging/release/distribution.
• The most actionable “supplier” identifiers for the US market come from NDA-linked regulatory documentation and the prescribing label “manufactured for / distributed by” fields.
• For contract manufacturing and licensing, the gating items are API impurity control, fixed-dose process validation, and NDA-aligned quality and change-control governance.

FAQs

1) How do I find the exact US manufacturer for JULUCA tablets from FDA labeling?
Use the “Manufactured for” / “Distributed by” statements in the US Prescribing Information and cross-reference the NDA holder in the FDA Orange Book entry.

2) Which part of JULUCA supply is most sensitive to manufacturing changes, API or drug product?
API and drug product are both tightly controlled, but API supplier changes are typically more sensitive due to impurity and polymorphic control and because they cascade into finished-dose comparability.

3) What evidence sources best support qualification of a new JULUCA CMO?
Qualify via GMP inspection readiness, documented process validation capability for fixed-dose combinations, and evidence of ability to support NDA-aligned batch release and regulatory change controls.

4) Do supplier changes affect DSCSA traceability for JULUCA?
Yes. DSCSA-compliant serialization and traceability depend on packaging/release execution at the sites responsible for traceable unit generation and labeling.

5) What commercial events most often disrupt JULUCA supply?
Finished-dose capacity constraints at key manufacturing and packaging sites, regulatory batch release delays, or controlled substance-like distribution issues driven by labeling/serialization changes.

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. U.S. Prescribing Information for JULUCA (dolutegravir and rilpivirine). U.S. Food and Drug Administration / FDA Label.