Last updated: May 28, 2026
MULTAQ (dronedarone) suppliers: manufacturers, key API sources, and contract manufacturing for tablets
Executive summary: MULTAQ (dronedarone) is supplied in the US as tablets by Sanofi (brand owner). The API supplier and commercial manufacturing network for MULTAQ tablets is not fully determinable from public-facing sources alone. Patent and regulatory records for MULTAQ focus on drug substance/formulation IP and approvals, not on a complete, auditable list of contract manufacturing organizations (CMOs) and API makers.
What can be stated from available public regulatory identifiers: MULTAQ is a Sanofi product and is marketed as dronedarone hydrochloride tablets in the US under NDA and FDA labeling that identify Sanofi as the sponsor/holder. The rest of the “supplier” chain (site-specific tablet manufacturing, sterilization, and dronedarone API production sites) is typically reflected in FDA facility listings, drug establishment registrations, and DMF/NDA manufacturing sections, which require pulling site-level records that are not present in the information provided.
Who manufactures MULTAQ (dronedarone) tablets in the US?
Direct answer: MULTAQ is supplied under Sanofi as the US sponsor/holder for the branded product.
Brand sponsor and marketing identity
- Brand/holder: Sanofi
- Dosage form: Oral tablets
- Active ingredient: Dronedarone (dronedarone hydrochloride)
What “supplier” can mean in pharma procurement
For procurement and risk assessment, “supplier” typically breaks into:
- Drug product manufacturer (site that presses/coats/packages tablets)
- API manufacturer (site that produces dronedarone)
- Packager (if different from tablet manufacturing)
- Release testing and QC lab (sometimes distributed)
Public summaries often name only the brand holder, not every site.
What companies supply dronedarone API for MULTAQ?
Direct answer: A site-resolved list of dronedarone API suppliers is not determinable from the information provided.
How API suppliers are normally evidenced
A complete, litigation-grade supplier map is usually built from:
- DMF references in the NDA manufacturing section
- FDA drug establishment registration and facility listing
- Inspection assignment history tied to establishment identifiers
- Labeler/holder vs. manufacturer fields in FDA drug listing data
Without these underlying facility references, the API supplier set cannot be stated as hard facts.
Which contract manufacturing organizations make MULTAQ tablets?
Direct answer: A confirmed CMO roster for MULTAQ tablets cannot be stated from the information provided.
Why brand holders are named but CMOs are not
- FDA and labeling often show holder/sponsor and sometimes “manufactured for” language.
- CMO identity often changes over time and is not always visible in static public-facing content.
What is the Orange Book status of MULTAQ (and does it list manufacturers)?
Direct answer: The Orange Book status and listings are tied to patent codes and exclusivity, not a complete manufacturer supply chain. The information provided here does not include Orange Book entries to enumerate patent-listed manufacturing or dosage-form-specific status.
What Orange Book can answer for “supplier” decisions
- Whether listed patents cover formulation/dosing and use
- Whether there is generic eligibility (including paragraph IV risk)
- Whether exclusivity delays would constrain supply competition
But it does not function as a supplier directory.
What patent landscape affects manufacturing and supplier switching for MULTAQ?
Direct answer: The information provided does not include the MULTAQ patent family or listed patents necessary to map manufacturing barriers or site switching restrictions.
Procurement relevance
- Process and formulation patents can constrain “drop-in” sourcing changes.
- Method-of-use patents can constrain therapeutic equivalence claims.
- Marketing exclusivity affects competitive entry timing, not direct manufacturing identity.
When does MULTAQ lose exclusivity and how does that impact supplier options?
Direct answer: Exclusivity timelines are not computable from the information provided because MULTAQ’s listed exclusivity and patent expiration dates are not supplied.
Commercial mechanics
- Branded manufacturing suppliers can still continue post-expiry.
- Generic entry affects price pressure and may expand API sources over time, but the timing and effect require specific expiration and challenge history.
How many ANDAs or generic entrants target MULTAQ, and who are they?
Direct answer: Competitor entry counts and filer identities are not determinable from the information provided.
How this would tie back to suppliers
- Successful ANDA supply chains tend to reveal additional API and tablet manufacturing sites.
- Without ANDA/public submissions or FDA summaries tied to MULTAQ, no credible supplier roster can be produced.
What generic or biosimilar risks exist for MULTAQ manufacturing and supply?
Direct answer: MULTAQ is a small molecule drug. The “biosimilar” framework does not apply. Generic entry risk depends on the ANDA/paragraph IV landscape, which is not provided here.
Key Takeaways
- MULTAQ is a Sanofi branded product for dronedarone tablets.
- A complete, named supplier list for MULTAQ, including API manufacturers and CMO tablet makers, cannot be produced from the information provided.
- Reliable “supplier procurement” mapping requires linking NDA manufacturing references (DMF/NDA section), FDA establishment records, and label/inspection site identifiers.
FAQs
- Does MULTAQ have multiple tablet strengths, and do supplier sites differ by strength?
- Are dronedarone API suppliers listed in MULTAQ labeling?
- Does FDA facility listing show the MULTAQ tablet manufacturing sites?
- Do MULTAQ manufacturing sites change after CMO transfers, and how is that reflected in FDA records?
- What documents confirm the actual dronedarone API DMF referenced by the NDA?
References (APA)
No sources were provided in the prompt, and none can be cited without access to the underlying Orange Book entries, NDA/DMF manufacturing sections, or FDA facility listing records.
