Suppliers and packagers for CIMDUO

CIMDUO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Labs Ltd	CIMDUO	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022141	NDA	Viatris Specialty LLC	49502-450-93	1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-06-25

Suppliers and packagers for CIMDUO

Last updated: June 4, 2026

CIMDUO suppliers: Who manufactures and supplies the branded combo product (FDA, label, and supply-chain coverage)

CIMDUO is a U.S.-marketed prescription combination product containing lamivudine (150 mg) and zidovudine (300 mg) used for HIV. Key “suppliers” in practice split into (1) commercial product manufacturers listed on the FDA label and (2) API and intermediate supply chains that are usually disclosed through the Orange Book, Drug Master Files (DMFs), and (where publicly available) corporate supply statements.

Publicly verifiable supplier identification requires FDA label/manufacturer data plus Orange Book and, for API, DMF linkages. With only the drug name provided and without the specific NDC/strength/formulation and marketed dosage form (tablet/capsule, etc.), a complete, accurate supplier roster cannot be produced.

Who supplies CIMDUO in the U.S. and what are the listed manufacturers on the label?

Featured snippet answer: The only reliable starting point for “who supplies CIMDUO” is the U.S. package insert label (manufacturer/distributor section) for each NDC and dosage form. That label identifies the manufacturer of record and sometimes the packager and sponsor.

What label fields identify the CIMDUO supplier?

Common label sections that name supply-chain parties:

• Manufacturer of record
• Distributor (sometimes the same entity as sponsor)
• Packager (if different)
• Sponsor holder (marketing authorization holder)

Which entities typically appear for combo antiretrovirals?

For HIV combination tablets, supply chains frequently involve:

• Branded product sponsor/labeler
• Contract manufacturing organization (CMO) producing the finished tablets
• API manufacturers listed via DMF or Orange Book (often not identical to the finished-dosage manufacturer)

How do you identify CIMDUO API suppliers: Orange Book and DMF pathways?

Featured snippet answer: API “suppliers” are identified through Orange Book patent listings and DMF references (when public), not by the branded label alone.

What Orange Book data helps map API sourcing?

Orange Book can connect:

• Drug product manufacturer (finished dosage)
• Patent-related holders
• For some products, the DMF-linked API references (not always explicit)

How do DMFs map to API manufacturers for lamivudine and zidovudine?

Lamivudine and zidovudine each have extensive generic ecosystems. Publicly mapping a specific DMF to a specific company is typically done via:

• DMF reference lists tied to the drug product
• Submission metadata in FDA disclosures (when accessible)
• Orange Book “active ingredient” and related listing structure

What is the Orange Book status of CIMDUO, and does it list manufacturing entities?

Featured snippet answer: The Orange Book lists drug products by active ingredient(s), strength(s), and dosage form/route, and provides patent and exclusivity status. It can also list the application holder and drug product listing.

How does Orange Book status change supplier visibility?

When the product is under active listing with patents/exclusivity, supplier details are usually stable through:

• Drug product listing company
• Patent assignees and expiration dates

When listings expire or change, the visible label manufacturer may differ from:

• Historical finished-dosage manufacturers
• API DMF holders

Which companies manufacture CIMDUO tablets (lamivudine/zidovudine), by strength and NDC?

Featured snippet answer: Supplier mapping must be done by NDC because a marketed combination product can have multiple NDCs that differ by strength, packaging, and sometimes manufacturer.

Why strength and NDC matter for a CIMDUO “supplier list”

• Different strengths can be produced in different facilities
• Different packaging sizes can be produced by different packagers
• Product changes can occur without public announcement beyond label updates

Supplier table structure (needed for an accurate build)

A complete table must include: | NDC | Dosage form | Strength | Labeler/sponsor | Manufacturer of record | Packager (if listed) | U.S. distribution entity | |---|---|---|---|---|---|---|

A supplier table cannot be filled accurately without the specific NDC(s) and label text.

Are there multiple CIMDUO suppliers due to contract manufacturing?

Featured snippet answer: Many legacy antiretroviral tablets have multiple manufacturing partners across time due to CMO contracting, packaging subcontracting, and FDA label refresh cycles.

What evidence indicates multiple suppliers

• Different manufacturers of record across label revisions
• Different NDCs tied to different companies
• Orange Book listing changes by application holder

What generic entry risks exist for CIMDUO that affect supplier strategies?

Featured snippet answer: Supplier strategy and sourcing risk rise as generic entry approaches, because finished dosage manufacturing capacity and API contracting often re-optimizes around expected volume.

Paragraph IV and litigation impact on supply

If there are Paragraph IV challenges involving lamivudine/zidovudine combinations, a settlement can:

• Permit an early generic launch for a limited set of NDCs
• Trigger supply-chain transition for branded volumes

A litigation-driven supplier map requires docket-level identification of:

• Challengers
• Filing years
• Settlement parties
• Launch dates

How do biosimilar and biologic factors apply to CIMDUO?

Featured snippet answer: Biosimilar frameworks do not apply because CIMDUO is a small-molecule combination (lamivudine and zidovudine), not a biologic.

What replaces biosimilar risk in small-molecule combos?

The dominant exclusivity and risk drivers are:

• Orange Book patents on formulation, process, and method of use
• Hatch-Waxman exclusivity and patent expiration sequencing
• Generic approvals via ANDA (bioequivalence and chemistry controls)

How does CIMDUO compare with other lamivudine/zidovudine combo supply patterns?

Featured snippet answer: The supply landscape for lamivudine/zidovudine combinations typically mirrors other legacy HIV fixed-dose combinations: branded label manufacturers rely on contract manufacturing and centralized API sourcing, while generics rely on multiple generic API suppliers and finished dosage CMOs.

Where supply chains often diverge

• API sourcing diversification is common among generics
• Finished dosage manufacturers may be fewer due to regulatory and scale constraints
• Finished product release and packaging can be localized to specific sites

Key Takeaways

• The only defensible way to name “suppliers for CIMDUO” is through FDA label manufacturer/distributor information by NDC, supplemented by Orange Book and (where available) DMF-linked API disclosures.
• A complete supplier roster cannot be produced from “CIMDUO” alone because multiple marketed NDCs and label revisions can reflect different manufacturing and packaging entities.
• A supplier map for business decisions must be built per NDC with fields covering manufacturer of record, packager, and application holder.

FAQs

1. What does the CIMDUO label say about the manufacturer of record?
   The manufacturer/distributor section of the package insert specifies the finished dosage manufacturer and/or distributor for each NDC.

2. How can I find CIMDUO’s application holder in FDA listings?
   The Orange Book drug product listing shows the application holder/labeler tied to each drug product entry.

3. Can the API suppliers for lamivudine and zidovudine be determined from public sources?
   Often through DMF linkages and FDA submissions referenced by drug product listings, not from the branded label alone.

4. Do generic versions of lamivudine/zidovudine fixed-dose combinations use different manufacturing sites?
   Typically yes; generics often use different finished dosage CMOs and expanded API supplier networks.

5. Does Paragraph IV litigation for CIMDUO affect manufacturing capacity or supply timing?
   It can affect launch timing and volumes, driving supplier contract renegotiation for finished dosage manufacturing and packaging.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/