Suppliers and packagers for ODEFSEY

ODEFSEY

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	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351	NDA	Gilead Sciences, Inc.	61958-2101-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)	2016-03-01

Odefsey Drug Suppliers: Who Manufactures and Supplies the Components, Finished Product, and Contract Services

Last updated: May 24, 2026

Odefsey is a fixed-dose combination of emtricitabine + rilpivirine (as rilpivirine hydrochloride) + tenofovir alafenamide (TAF). Supply chain responsibility typically splits across (1) API manufacture for each active ingredient, (2) finished-dose manufacturing of the tablet, and (3) packaging/labeling and distribution via U.S. and global commercial channels.

What companies supply odefsey tablets and who is the finished-dose manufacturer?

The finished product is marketed in the U.S. by Gilead Sciences, Inc. under the Odefsey NDA product. Finished-dose manufacturing is commonly performed by contract manufacturing organizations (CMOs) under Gilead’s product supply agreements, with labeling and release coordinated through the NDA holder’s quality system.

Finished-dose responsibility (U.S. market):

• NDA holder / marketer: Gilead Sciences, Inc. (Odefsey brand)
• Tablet manufacturing: performed by one or more Gilead-managed manufacturing sites and/or CMOs, with exact site identities tied to current commercial batch release.

Where supplier identification appears in regulatory filings

• FDA labeling and drug product listing (NDC-level) typically identifies the labeler and often the manufacturer of record.
• FDA Drug Establishment Registration and Listing (DRLM) reflects manufacturing sites for drug products and drug substances.
• Orange Book entries for Odefsey reference patents, not detailed manufacturing roles; supplier clarity is usually sourced from FDA labeling, DRLM, and manufacturing site registries.

Which companies supply the active pharmaceutical ingredients for emtricitabine, rilpivirine, and tenofovir alafenamide in odefsey?

Odefsey’s supply chain depends on three drug substances:

• Emtricitabine (FTC)
• Rilpivirine (RPV-HCl)
• Tenofovir alafenamide (TAF)

Emtricitabine suppliers for odefsey

Common FTC supply roles in global HIV generics and branded supply chains include:

• API manufacturers in China/India and Western CMOs that operate under quality systems acceptable to Gilead.
• Multiple alternate suppliers may exist for supply resilience, with qualification recorded through CMC sections of the NDA.

Rilpivirine hydrochloride suppliers for odefsey

Rilpivirine is typically supplied from specialized synthetic API plants with established control strategies for:

• salt formation and polymorph control
• impurity profiles
• consistent particle size and solid-state properties affecting formulation performance.

Tenofovir alafenamide (TAF) suppliers for odefsey

TAF is the most CMC-intensive component. Supply usually includes:

• dedicated TAF API manufacturers with validated synthetic routes and impurity controls
• DMF-backed or cross-referenced API manufacturing packages
• tight lot-to-lot control due to bioavailability sensitivity.

Net supplier architecture

• Each API has its own supplier set and quality agreement.
• Finished-dose manufacturers typically do not supply the APIs; they purchase them under QMS-controlled raw material specifications.

How is odefsey manufactured: what are the formulation and packaging supply steps?

Tablet supply chain for Odefsey typically involves:

1. API procurement and incoming QC release
2. blending (FTC + rilpivirine + TAF with excipients)
3. tablet compression / coating (if applicable to the specific commercial presentation)
4. in-process controls and finished product release testing
5. packaging into bottles or blister packs
6. labeling and distribution through Gilead’s channels

Packaging and secondary supply are often provided by regional packaging partners and distribution networks contracted under Gilead’s logistics agreements.

What FDA listings show odefsey supplier sites (labeler, manufacturer, packager)?

To identify real “suppliers” in the regulatory sense, the most direct sources are FDA systems tied to product and site registration:

• FDA NDC Drug Product listing: shows labeler and often manufacturer of record by NDC.
• FDA DRLM (Drug Establishment Registration and Listing): shows which sites are registered to manufacture drug products and drug substances and their role (manufacturer, packer, labeler).
• FDA product labeling: includes “Manufactured for/By” language that typically maps to the manufacturer-of-record and packing operations.

These sources connect a specific Odefsey NDC to:

• the company responsible for release
• the site and often the process role (manufacture, packaging, label)

Who supplies odefsey in the U.S.: distributor network and commercial logistics?

In the U.S., Odefsey is distributed via standard pharmaceutical channels:

• wholesalers and specialty pharmacy networks that carry Gilead’s antiretroviral products
• direct-to-provider or specialty distribution pathways used by Gilead and its logistics partners

Distributor identity is usually not the same as:

• NDA holder
• finished-dose manufacturer
• API manufacturer

Does odefsey have multiple suppliers or single-source dependency?

Brand fixed-dose combinations like Odefsey generally use:

• qualified secondary sources for each API to manage supply continuity
• multiple packaging and release sites (or alternate sites) depending on commercial demand and regulatory readiness

Supply continuity risk concentrates at:

• TAF API availability (most CMC-constrained component)
• tablet manufacturing capacity and release testing capacity
• packaging lines for blister or bottle formats

Key supplier-to-risk map for odefsey

Supply chain node	What it controls	Where failures show up
TAF API supplier	cost, purity, solid-state control	API availability, release rejection risk
RPV-HCl API supplier	salt form, impurity profile	lot rejection, formulation performance shifts
FTC API supplier	impurity profile and dissolution	release testing, stability risk
Tablet manufacturer	blend uniformity, compression/coating	batch release delays, recalls
Packaging/labeling	line capacity, packaging integrity	distribution delays, label mix-ups

Key Takeaways

• Odefsey supply is organized around three API supply nodes (FTC, RPV-HCl, TAF) plus a finished-dose tablet manufacturing and packaging network under Gilead Sciences, Inc. as the NDA holder/marketer.
• Supplier identification that is actionable for procurement, litigation, or CMC diligence is typically sourced from FDA NDC labeling/manufacturer-of-record and FDA DRLM registered sites, mapped by Odefsey NDC.
• The most supply-constrained component is usually TAF, where API qualification and solid-state control materially impact continuity.

FAQs

1) Who is the manufacturer of record for odefsey tablets?

The manufacturer of record is identified on the Odefsey prescribing information/labeling and NDC listing as the “Manufactured for/By” party, tied to the product’s NDC.

2) Which contract manufacturers make odefsey tablets under Gilead?

Tablet manufacturing is performed at registered drug product sites listed in FDA DRLM, which includes contract manufacturing roles for the Odefsey product.

3) What companies manufacture tenofovir alafenamide (TAF) used in odefsey?

TAF suppliers are the API manufacturers registered and qualified under Gilead’s NDA CMC chain for the drug substance.

4) How do I find odefsey packaging suppliers in FDA records?

Use the product’s NDC in FDA DRLM to locate registered packers/labelers associated with Odefsey.

5) Are odefsey APIs sourced from multiple suppliers?

Fixed-dose combination brands commonly maintain alternate qualified API sources for continuity, especially for the CMC-intensive component TAF, though the exact roster is visible via FDA registration and CMC disclosures tied to commercial lots.

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References

1. U.S. Food and Drug Administration. Odefsey prescribing information and labeling (accessed via FDA drug label database).
2. U.S. Food and Drug Administration. FDA Drug Registration and Listing System (DRLM) entries for Odefsey drug product and registered manufacturing sites.
3. U.S. Food and Drug Administration. NDC drug product listing for Odefsey (labeler/manufacturer-of-record by NDC).