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Suppliers and packagers for generic pharmaceutical drug: Tafamidis
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Tafamidis
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: Tafamidis
TAFAMIDIS Suppliers: Who Manufactures and Supplies Tafamidis (Capsules) for Market Access?
Executive summary
Tafamidis commercial supply is anchored to Pfizer’s branded product, Vyndaqel (tafamidis meglumine). Current market supply for tafamidis in the US is tied to Pfizer Manufacturing and the company’s regional contract manufacturing network for finished dosage forms. On the APIs and key intermediates, the competitive landscape typically involves specialty chemical and API suppliers qualified through Pfizer’s supply chain, with manufacturers varying by plant and region. For downstream distribution, Pfizer is the marketing authorization holder and primary supplier to US wholesalers, with additional layers provided by distributors and specialty pharmacy channels.
Who supplies tafamidis meglumine for branded Vyndaqel in the US?
Primary branded supply: Pfizer
- Marketing authorization holder / brand owner: Pfizer
- Product: Vyndaqel (tafamidis meglumine), oral capsules
How supply is typically structured for tafamidis
- API and intermediates sourced from qualified specialty chemical manufacturers.
- Finished dosage form produced under Pfizer’s manufacturing network or via contract manufacturing organizations (CMOs) with validated processes.
- Distribution through Pfizer commercial operations and wholesale/specialty distribution partners.
Supplier identification in litigation and regulatory data
- US patent litigation and FDA manufacturing information can point to specific facilities via labeling, site-specific FDA manufacturing references, and NDA/ANDA manufacturing history.
- For tafamidis, supplier plant identification often changes over time with scale-up, tech transfer, and new commercial lots.
Featured snippet answer: Tafamidis meglumine supply for Vyndaqel in the US is primarily provided by Pfizer, with API/intermediate work and some finished-dose manufacturing performed by qualified external suppliers and/or CMOs in Pfizer’s supply chain.
What companies manufacture tafamidis active pharmaceutical ingredient (API)?
API supply reality for specialty drugs
- Tafamidis is a small-molecule, high-value orphan/rare-disease product. API supply is usually handled by a limited pool of qualified API manufacturers due to tight control of polymorph, salt form (meglumine), and impurity specs.
How to map API suppliers for tafamidis in practice
- Track DMF holders for the tafamidis route and intermediate DMFs (where applicable).
- Cross-reference NDA Chemistry Manufacturing and Controls (CMC) facility listings for API manufacturing and drug product manufacturing sites.
- Review FDA inspection history tied to application manufacturing sites (facility-level, not always supplier-name level).
- Use contract manufacturing announcements only where Pfizer explicitly names sites or partners.
API supplier list A complete, defensible vendor list (names + sites + role) requires precise mapping to FDA-listed manufacturing facilities and/or DMF holder identities for tafamidis and tafamidis meglumine. Without that facility-to-supplier resolution, any named vendor list risks inaccuracies.
Which contract manufacturing organizations (CMOs) produce tafamidis capsules?
Typical CMO involvement
- For niche specialty products, Pfizer frequently uses CMOs for:
- Scale-up batches,
- Tech-transfer launches,
- Batch balancing across plants,
- Packaging and secondary operations.
What is determinative for tafamidis
- The drug product manufacturing facility is what matters for lot release and commercial supply continuity.
- CMO identity is only actionable if tied to a specific approved manufacturing site used for commercial supply.
Featured snippet answer: Tafamidis capsule manufacturing is handled through Pfizer’s approved drug product manufacturing network, with possible CMO participation, but firm supplier identification depends on the site-specific FDA-listed manufacturer(s) for Vyndaqel commercial lots.
What is the Orange Book status of tafamidis products and how does it affect supplier competition?
Orange Book use case for supply
- The Orange Book ties to patents and exclusivity but does not directly list API suppliers.
- It does show whether other applicant products exist, which can indicate alternative supply chains via generic or authorized alternatives.
Supplier competition linkage
- If no approved generic/authorized alternative exists for the same dosage form and route, supplier competition is largely confined to:
- internal Pfizer scale-up, and
- external supply of API/intermediates for Pfizer’s procurement.
Bottom line
- Orange Book status shapes the number of finished-dose product supply sources, but tafamidis suppliers are still constrained by brand-specific commercial manufacturing rights and quality systems.
When does tafamidis lose exclusivity and what supplier shifts could follow?
Exclusivity and patent-driven supply
- Tafamidis commercial continuity is dictated by a combination of:
- patent expirations,
- regulatory exclusivity periods,
- and any Hatch-Waxman settlement outcomes (if challenged).
Supplier shifts after exclusivity
- Likely changes include:
- additional qualified API and finished-dose manufacturers entering supply,
- generic or authorized generic launching via different manufacturing networks,
- substitution in pharmacy supply chains.
Actionable constraint
- To produce a supply-timeline with date-specific transitions, the exact Orange Book patent estate and exclusivity expiration dates for tafamidis dosage forms and indications are required.
What generic or biosimilar entry risks exist for tafamidis (supply diversification)?
Not a biologic
- Tafamidis is a small molecule, so “biosimilar risk” is not applicable.
- The relevant entry risk is generic tafamidis meglumine (or other salt/form) under ANDA pathways after patent/exclusivity barriers are cleared.
Supply diversification mechanism
- Generic entry typically multiplies supply sources:
- new API vendors,
- new drug product manufacturing sites,
- new packaging suppliers.
Key point
- Current supplier landscape for tafamidis in a given market depends on whether ANDAs are approved and launched, which is directly tied to the patent estate and exclusivity status.
Which firms distribute tafamidis in the specialty pharmacy channel?
Distribution layers
- In the US, tafamidis branded products typically move through:
- wholesalers to pharmacies, and/or
- specialty distribution with demand forecasting and prior authorization support.
Actionable mapping
- Distribution companies change by contract year and payer channel. Reliable, actionable supplier lists require tracing distribution agreements and distribution center usage, which is not stable.
Featured snippet answer: Distribution of tafamidis is carried out through Pfizer’s commercial network plus wholesale/specialty distribution partners supporting rare-disease access workflows.
How strong is Pfizer’s patent estate for tafamidis and what does it imply for supplier sourcing?
Patent estate impact
- A strong estate limits generic and authorized alternative entry.
- That keeps procurement focused on Pfizer’s qualified supply chain rather than competitive ANDA manufacturing.
Supplier sourcing implication
- Higher certainty of sustained branded demand lets Pfizer lock in long-term:
- API capacity,
- salt formation capacity,
- and final dosage form release capacity.
TAFAMIDIS supply chain map (commercial model)
| Layer | What to look for | Likely supplier types | Why it matters |
|---|---|---|---|
| API / intermediates | DMF holders, API manufacturing site approvals | Specialty API firms, intermediate chemical suppliers | Defines impurity profile, cost, continuity |
| Drug product | FDA-listed drug product manufacturing sites | Pfizer plants and/or CMOs | Determines capsule lot release capacity |
| Packaging | Bottling/capsule packaging sites | Specialized packaging suppliers | Impacts backorders and lead times |
| Distribution | Wholesalers and specialty distributors | Distributor networks under Pfizer contracts | Impacts pharmacy fill rates and access |
Key constraints on naming “suppliers” for tafamidis
To produce a defensible supplier list (company names tied to specific roles such as API manufacturer, intermediate supplier, drug product manufacturer, packaging site), the supplier must be pinned to a specific FDA-listed manufacturing facility and/or DMF identity used for tafamidis commercial supply. Without that facility-to-name resolution, a named-vendor list would not meet the standards for patent and regulatory diligence.
Key Takeaways
- Pfizer is the primary supplier and marketing authorization holder for branded Vyndaqel (tafamidis meglumine) in the US.
- Tafamidis commercial supply depends on qualified API/intermediate manufacturers and approved drug product manufacturing sites that may include CMOs within Pfizer’s network.
- Supplier diversification from generic entry is contingent on Orange Book patent and exclusivity status and any subsequent ANDA launches.
- A complete supplier roster requires facility-level mapping to FDA-listed manufacturers / DMFs used for commercial lots.
FAQs
1) Does Pfizer manufacture tafamidis capsules in-house or use CMOs?
Tafamidis finished-dose supply is produced through Pfizer’s approved manufacturing network, which can include CMOs depending on site qualification and commercial batch planning.
2) How can I identify the tafamidis API suppliers used for commercial lots?
The most rigorous route is facility mapping through FDA CMC references and DMF-linked manufacturing identities tied to the approved product.
3) Do generic tafamidis products use different API suppliers than Vyndaqel?
If and when generics launch, they typically qualify their own API and drug product manufacturing sites, which usually diversifies vendor lists from Pfizer’s supply chain.
4) What types of intermediates constrain tafamidis production supply?
Salt formation (meglumine), key synthetic intermediates, and impurity-control steps generally constrain capacity for high-purity specialty APIs.
5) What supply chain bottlenecks most often affect tafamidis availability?
API capacity, salt-form manufacturing, and drug-product lot release at the approved capsule manufacturing sites are the usual chokepoints.
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). Drugs@FDA: Vyndaqel (tafamidis meglumine). https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). Drug Manufacturing Facilities (Drug Site) information and inspection resources. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references
- Pfizer. (n.d.). Vyndaqel (tafamidis meglumine) prescribing information and product labeling. https://www.pfizer.com/
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