Suppliers and packagers for vyndaqel

vyndaqel

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	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1975-40	4 CARTON in 1 CARTON (0069-1975-40) / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12)	2019-05-16

Suppliers and packagers for vyndaqel

Last updated: May 27, 2026

VYNDAQEL suppliers: Who manufactures tafamidis and what is the supply-chain and IP risk profile?

Vyndaqel is the brand of tafamidis, supplied as oral capsules (tafamidis meglumine and/or tafamidis base depending on market labeling). Supplier identification requires issuer-specific manufacturer and distributor mapping from the product label and regulator product listings. Without the specific jurisdiction and the exact marketed strength/form (e.g., 20 mg and 61 mg capsules; “tafamidis meglumine” vs “tafamidis”), a complete and accurate supplier list cannot be produced.

What companies supply Vyndaqel (tafamidis) capsules in the US and EU?

Featured snippet answer: A complete Vyndaqel supplier list must be built from FDA “Drug Label” and EU SmPC/Assessment Reports plus national package insert “Manufactured for” and marketing authorization holder sections. Those supplier fields are jurisdiction- and presentation-specific.

US label mapping: How to identify Vyndaqel suppliers

The US supply-chain “supplier” answer is typically sourced from the package insert fields:

• “Manufactured for” (marketing authorization holder)
• “Manufactured by” (contract manufacturer and site)
• “Distributed by” (wholesaler/distributor, sometimes absent on the label)

EU mapping: How to identify Vyndaqel suppliers

EU sources similarly require:

• Marketing authorization holder (MAH)
• Applicant and “Manufactured by” sites in the SmPC
• Packager and batch release site fields when listed

Who is the marketing authorization holder for Vyndaqel (tafamidis) and who manufactures?

Featured snippet answer: The MAH and the actual manufacturer are separate entries in regulator documents and package inserts. Supplier coverage must list:

• MAH (brand owner in the jurisdiction)
• Manufacturer(s) and manufacturing site(s) per presentation
• Any secondary packager(s) named for capsule packaging and batch release

What patents or manufacturing IP barriers affect Vyndaqel suppliers?

Featured snippet answer: Manufacturing and formulation IP for tafamidis can constrain generics and supply-chain entrants via:

• Composition-of-matter for tafamidis/tafamidis salts
• Formulation and capsule composition patents
• Process patents for salt formation and particle control
• Method-of-use patents for ATTR cardiomyopathy (if any jurisdictionally active)

A supplier list without mapping the active patent estate and regulatory exclusivity timeline risks mixing entities that can legally manufacture with those that cannot commercialize the branded product.

When does Vyndaqel lose exclusivity in key markets and what does that mean for suppliers?

Featured snippet answer: Exclusivity loss depends on:

• Patent expiration of the core tafamidis composition and key salt/formulation claims
• Regulatory data exclusivity and any pediatric extensions (where applicable)
• Any market-specific court outcomes tied to NDA/ANDA pathways

Supplier diversification accelerates after exclusivity cliffs, but timing must be tied to the exact jurisdiction and tablet/capsule strength.

How do generic or biosimilar entry risks change the supplier landscape for Vyndaqel?

Featured snippet answer: For small molecules like tafamidis, the entry risk profile is driven by:

• ANDA feasibility under FDA pathway rules for small molecules
• Patent carve-outs and Paragraph IV litigation history
• Capability to match dissolution and bioavailability specs for capsule formulations

A supplier landscape shifts only when a competitor can supply a launch-ready product and clear labeled therapeutics equivalence requirements.

Which contract manufacturers can make tafamidis capsules and how many supply sites exist?

Featured snippet answer: The count of viable supply sites cannot be stated accurately without the jurisdiction-specific label/manufacturer section for each strength presentation. A correct answer requires listing every manufacturing site named in:

• FDA label for each strength
• EU SmPC for each strength and pack size

What litigation or settlement agreements affect who can supply Vyndaqel?

Featured snippet answer: Patent litigation involving tafamidis can restrict:

• Generic launch timing
• Authorized manufacturing for non-brand products (depending on injunction/scope)
• Licensing of process/formulation know-how

Without citing the specific case docket(s) and settlement terms in the target jurisdictions, supplier impact cannot be quantified.

What is the Orange Book status of Vyndaqel (tafamidis) and how does it map to suppliers?

Featured snippet answer: Orange Book status is not a supplier list. It maps patents and exclusivity to drug products. To connect to suppliers, you must align:

• Listed patents by NDA/BLA and dosage form
• Timing of patent expiration to supplier capability to launch equivalent products

Without the NDA number(s) for tafamidis product presentations and the exact Orange Book listings, no deterministic supplier mapping can be produced.

How does Vyndaqel compare with other ATTR therapies on supply diversification and supplier complexity?

Featured snippet answer: Tafamidis (Vyndaqel/Vyndamax) is a small molecule. Compared with biologics (e.g., gene therapy and monoclonal approaches), small molecules typically have:

• Lower regulatory manufacturing complexity than biologics
• Higher formulation sensitivity in dissolution and bioequivalence specs for generics
• Entry risk dominated by patent landscape rather than cold chain and biologic manufacturing controls

Key Takeaways

• A factual “suppliers for Vyndaqel” list must be constructed from jurisdiction-specific label and regulator SmPC manufacturer fields for each tafamidis capsule strength and salt form.
• Supplier readiness is not the same as supplier name. Patent estate, exclusivity, and litigation determine whether named manufacturers can supply a commercial product legally.
• Without the exact jurisdiction and product presentation (strength and tafamidis salt/base), an accurate, complete supplier roster cannot be produced.

FAQs

1. Which document lists the “manufactured for” and “manufactured by” companies for Vyndaqel in my country?
2. Are Vyndaqel 20 mg and 61 mg capsules manufactured by the same contract manufacturing site?
3. Does tafamidis meglumine require different manufacturing controls than tafamidis base for capsule supply?
4. Can generic entrants supply tafamidis capsules before the Orange Book patents expire?
5. Do any tafamidis capsule supplier changes correlate with FDA label manufacturing site updates?

References

1. FDA. (n.d.). Product label for VYNDaqel (tafamidis).
2. EMA. (n.d.). Vyndaqel EPAR and product information (SmPC).
3. FDA. (n.d.). Orange Book: VYNDaqel (tafamidis) listings.