Suppliers and packagers for vyndamax

vyndamax

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161	NDA	Pfizer Laboratories Div Pfizer Inc	0069-8730-30	30 BLISTER PACK in 1 CARTON (0069-8730-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-8730-01)	2019-08-27

VYNDAMAX suppliers and upstream manufacturers: who makes Vyndamax (tafamidis) capsules, API, and key components

Last updated: May 26, 2026

VYNDAMAX (tafamidis) is supplied via a branded, FDA-approved manufacturing supply chain centered on tafamidis drug substance and tafamidis capsule drug product. The supplier set for a given market is determined by the listed FDA label “Manufactured for”/“Distributed by” entities and the FDA Drugs@FDA/Orange Book manufacturing/distribution listings for the specific NDA.

Who supplies VYNDAMAX (tafamidis) in the US market?

Answer: The US commercial supply chain for VYNDAMAX is anchored on the NDA holder/distributor named on the FDA label for VYNDAMAX and on the FDA-registered manufacturing sites used to produce the tafamidis capsules.

What entities are typically “suppliers” on the label?

Label-level supplier identification usually includes:

• Company listed as the marketing authorization holder and/or “manufactured for”
• Company listed as “distributed by” (sometimes different)
• Contract manufacturing organization (CMO) listed as the actual manufacturing site for capsules and/or packaging
• Supplier lists for drug substance and/or capsule components are usually not fully enumerated on the public label, so the next layer of supplier detail is taken from FDA inspection/manufacturing listings and Orange Book “manufacturing information” fields for the NDA

Orange Book tie-in

Answer: The most reliable public mechanism to map the “supplier set” for VYNDAMAX is the Orange Book entry for the VYNDAMAX NDA, using the listed:

• NDA number
• Dosage form (tafamidis capsules)
• Marketing status
• Patent-protection tied to the product line
• Manufacturing information (where available in the entry records)

What drug substance (tafamidis API) suppliers feed VYNDAMAX capsules?

Answer: Tafamidis drug substance suppliers are identified through Orange Book manufacturing information and related FDA listing records tied to the VYNDAMAX NDA, which link the drug substance and drug product manufacturing sites.

Why API supplier names rarely appear on the consumer label

Most consumer-facing labels do not enumerate API suppliers, because:

• NDA holders frequently use multiple qualified suppliers
• API manufacturing may be done at internal sites and/or by CMOs under supply agreements
• FDA listing disclosure for drug substance suppliers can be partial compared with drug product sites

How API supplier mapping is typically done in practice

Supply chain mapping for tafamidis API is usually triangulated using:

• Orange Book “Manufacturing Information” for the NDA
• FDA drug listing manufacturing site data
• Public CMO manufacturing disclosures in inspection databases and consent decrees (when applicable)
• Contract or site-specific references in patent specifications, where they often credit assignees and manufacturers for specific intermediates

Which contract manufacturing sites make VYNDAMAX (tafamidis) capsules?

Answer: Contract manufacturers and packaging sites are identified by the “Manufactured at” and “Packaged by” fields on the FDA label and by the NDA listing manufacturing details.

Packaging and secondary supply chain

For capsules, the practical supplier “bottleneck” often sits at:

• Capsule filling and sealing
• Blister/HDPE bottle packaging lines
• Tamper-evident and desiccant packaging components (where used)
• Labeling and distribution UDI compliance

How do VYNDAMAX suppliers differ by dosage strength and package type?

Answer: The supplier set can change by:

• Capsule strength (tafamidis dosing regimen)
• Market package presentation (bottles vs cartons, blister packs where applicable)
• Country distribution agreements (if non-US manufacturing sites are used for certain lots)

What to look for on the Orange Book entry

The Orange Book often keeps dosage form and strength distinct, which can correspond to:

• Separate packaging/labeling operations
• Separate drug product manufacturing sites even if the API source is shared

What is the VYNDAMAX licensing and distribution structure that affects suppliers?

Answer: The supplier structure is determined by the NDA holder’s commercial model, including direct manufacturing vs reliance on contract manufacturers, and by distribution arrangements.

Distribution vs manufacturing are not the same

For “supplier” questions, companies listed on the label can be:

• Marketing/distribution entities without running manufacturing operations
• Or both marketing and manufacturing entities when the NDA holder uses internal facilities

Supply chain risk view

From a business continuity lens, supplier risk is concentrated in:

• Single-site drug product manufacturing (if present)
• Single-site packaging/labeling
• Single API qualifying site for tafamidis drug substance

What upstream materials suppliers matter for tafamidis capsule production?

Answer: Critical upstream suppliers typically include:

• Capsule shell material (gelatin or HPMC components depending on formulation strategy)
• Pharmaceutical excipients (binders, fillers, disintegrants)
• Colorants and imprint ink systems
• Desiccant/tamper-evident components (if used in marketed packaging)

Why excipient suppliers are hard to name publicly

Excipient supplier names are usually not disclosed on the public label and are often controlled under:

• Quality agreements
• NDA manufacturing changes submissions
• Trade secret and supply-contract confidentiality

Public patent literature can sometimes identify excipient classes and grades, but rarely supplier-company names.

What information can you use to verify VYNDAMAX suppliers for compliance and procurement?

Answer: Use the label and FDA-registered manufacturing listings for the specific NDA, then map them to lot-level distribution records where available.

Verification checklist used by regulated buyers

• FDA label “Manufactured for” and “Distributed by”
• Label “Manufactured at” and “Packaged by” site lines for capsule manufacturing and packaging
• Orange Book “Manufacturing Information” for the NDA and dosage form
• Lot or distribution certificate references (for internal procurement qualification)
• Regulatory inspection outcomes for named manufacturing sites (where accessible)

Key takeaways

• VYNDAMAX supplier identification is anchored on the NDA-linked FDA label entities and Orange Book manufacturing information tied to the tafamidis capsules.
• Drug product manufacturing and packaging sites are typically named on the label; API supplier names are less visible and usually require Orange Book manufacturing records and NDA manufacturing listings.
• “Supplier” can mean different things (marketing/distribution vs manufacturing vs packaging vs upstream excipients). The highest-confidence procurement map comes from FDA label + Orange Book NDA manufacturing fields.

FAQs

1. How do I find the Orange Book entry for VYNDAMAX and locate its manufacturing information?
2. Are VYNDAMAX drug substance (tafamidis API) suppliers disclosed on the label or only in FDA listings?
3. Do VYNDAMAX packaging manufacturers change by lot, strength, or bottle vs blister format?
4. What manufacturing changes are typically submitted to FDA for VYNDAMAX capsule site swaps?
5. What “supplier risk” indicators apply to tafamidis capsules in US distribution planning?

References

1. FDA. Drugs@FDA. VYNDAMAX (tafamidis) prescribing information and application details.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. VYNDAMAX (tafamidis) NDA entry and manufacturing information.
3. FDA. Label information for VYNDAMAX (tafamidis) capsules (manufactured for / distributed by / manufactured at / packaged by).