Suppliers and packagers for COMPLERA

COMPLERA

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	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123	NDA	Gilead Sciences, Inc.	61958-1101-1	30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)	2011-08-10

Complera Suppliers: Which API, Component, and Contract Manufacturers Supply the Brand and Generics

Last updated: May 27, 2026

What companies supply Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for US and global markets?

Complera is a fixed-dose combination product containing emtricitabine (FTC), rilpivirine (RPV), and tenofovir disoproxil fumarate (TDF). The practical supplier set for Complera breaks into three layers: (1) originator/brand manufacturing, (2) API and key intermediate suppliers, and (3) secondary operations such as tableting, coating, bottling, packaging, and logistics. Supplier identification is generally anchored to FDA facilities listed for the reference product and to publicly disclosed contract manufacturing at NDA/ANDA amendments, inspections, and drug master files.

Key commercial reality: Complera’s supply chain is dominated by Gilead and Gilead’s manufacturing network, with API supply sourced from qualified vendors through Gilead’s approved supplier programs. Generic and “authorized” market supply also depends on each ANDA’s approved manufacturing site list.

Which manufacturing sites typically appear for Complera on FDA labels?

The most reliable “supplier” view for Complera is the set of drug product manufacturing and packaging facilities listed on FDA labels (and in the Drug Listing and inspection history). For fixed-dose combinations, these sites commonly include:

• Drug product manufacturing (tablet core formulation + compression)
• Film-coating and imprinting lines
• Packaging and labeling sites
• Warehousing and distribution centers listed in inspection databases

Because the question is “suppliers,” business users typically need the concrete FDA-identified manufacturing/packaging facilities, not generic company names. Those must be taken from the most current FDA label for the Complera NDCs in question and the corresponding facility lists.

What is the FDA Orange Book status of Complera, and does that change the supplier landscape?

Complera is listed in the FDA Orange Book as a brand-name NDA product with associated patents and exclusivities. Supplier landscape changes when exclusivity ends, because more ANDAs begin commercial supply and add new manufacturing sites.

Featured snippet answer: Orange Book status controls whether generic suppliers can launch and under what regulatory pathway, which in turn drives new drug product manufacturers and packagers.

How do Orange Book listings affect who can supply Complera?

Once an ANDA is approved for one or more strengths and dosage forms:

• The generic applicant can supply the market using its own approved manufacturing and packaging sites.
• The number of suppliers increases with each approved ANDA.
• Litigation and settlement agreements can limit launch timing, limiting supply even after approval.

Which APIs and key intermediates are required to manufacture Complera, and who supplies them?

Complera drug substance components:

• Emtricitabine (FTC)
• Rilpivirine (RPV)
• Tenofovir disoproxil fumarate (TDF) (TDF is a prodrug salt of tenofovir)

What does an FTC/RPV/TDF supply chain usually include?

Even when the drug product is made by one party, APIs often come from specialized chemical manufacturers and then pass through:

• API synthesis and purification
• Salt formation and crystallization for TDF
• Material exchange with controlled specifications
• Quality release under cGMP quality agreements

Who qualifies as an “API supplier” for FTC, RPV, and TDF?

In practice, API suppliers are the facilities whose DMFs (Drug Master Files) or NDA supplier sections are referenced by the NDA/ANDA applicant, plus those listed in FDA inspections for API sites.

For high-stakes sourcing, the correct approach is to map:

• NDA reference product approvals and amendment history to DMFs/supplier references
• FDA facility lists to actual manufacturing locations

What contract manufacturers make the Complera tablets and handle packaging?

For fixed-dose combination tablets, contract manufacturing typically spans:

• Tablet manufacturing (blending, granulation, compression)
• Film coating and finishing
• Primary packaging (bottles/blisters depending on NDC)
• Secondary packaging and distribution

What to look for on FDA labels to identify the “supplier” of the drug product

The label usually identifies:

• Manufacturer(s) of the product
• Packager(s)
• Sometimes the company responsible for distribution

From a business perspective, the contract manufacturer set is the set named on the label plus the FDA-registered facilities.

Are there generic Complera suppliers, and which companies are the main launch sources?

Generic entry depends on:

• patent and exclusivity timelines for the combination
• ANDA approval status
• any Paragraph IV challenges and settlement terms

Which companies typically compete in HIV FDCs like Complera?

In the US market, generic and authorized generics for antiretrovirals are often supplied by:

• large generic manufacturers (broad ANDA portfolios)
• regional generic leaders for complex FDCs
• companies focused on HIV lifecycle and combination products

However, without tying to specific ANDA approvals and their approved manufacturing sites for each Complera strength, naming specific generic suppliers risks listing companies that are not approved for that NDC/strength.

How many suppliers are in the Complera market by strength, NDC, and dosage form?

Supplier count must be computed from:

• NDC-specific approvals (not just the active ingredients)
• ANDA approvals for each strength
• label/manufacturer entries per NDC

Without NDC-level mapping, the supplier count can’t be reliably stated.

When does Complera lose exclusivity, and how does that expand supplier entry?

Exclusivity and patent timelines determine generic commercial availability, which drives supplier diversification.

• Any Hatch-Waxman exclusivity expiry triggers possible ANDA launches.
• Paragraph IV litigation and settlements can delay entry even after eligibility.

What patent challenges (Paragraph IV) affect Complera’s generic entry and suppliers?

Paragraph IV actions can produce:

• automatic stays
• court-defined launch dates
• settlement-triggered “authorized launch” or delayed launch

Supplier impact:

• competing manufacturers can remain out of the market until settlement or final rulings
• once supply opens, multiple manufacturers can enter with different approved sites

What manufacturing/IP barriers can block new suppliers of Complera?

For fixed-dose antiretroviral combinations, barriers include:

• process and formulation patents covering specific manufacturing steps
• bioequivalence constraints tied to dissolution and stability specifications
• controlled particle size and crystallization requirements for TDF salt forms
• validated analytical methods and impurity profiles

How does Complera compare with similar FTC/RPV/TDF products in supplier structure?

Competitive comparability matters because combination products can share:

• formulation platforms
• manufacturing know-how
• coating/impurity control strategies
• API procurement frameworks

This often shifts supplier relationships toward a small set of contract manufacturers that can handle multilayer quality and stability needs.

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Key Takeaways

• “Suppliers for Complera” is best defined as (a) FDA-identified drug product manufacturing and packaging facilities for each Complera NDC, plus (b) the NDA/ANDA-referenced API/DMF facilities for FTC, RPV, and TDF.
• Orange Book status and patent/exclusivity timelines directly control the number of active suppliers because they constrain ANDA launch.
• Supplier expansion happens at the NDC and strength level as ANDAs gain approval and can commercialize.

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FAQs

1. Which FDA-registered facilities manufacture and package Complera for each NDC/strength?
2. What DMF and supplier references are used for emtricitabine, rilpivirine, and tenofovir disoproxil fumarate in Complera?
3. How many ANDAs are approved for Complera, and which companies supply each approved NDC?
4. Do Paragraph IV settlements delay generic Complera launch, and which manufacturers are affected?
5. What contract manufacturing steps (coating, packaging, labeling) are most often outsourced for Complera tablets?

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA.
3. U.S. Food and Drug Administration. DailyMed.