Suppliers and packagers for TIKOSYN

TIKOSYN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800-60	60 CAPSULE in 1 BOTTLE (0069-5800-60)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800-61	14 CAPSULE in 1 BOTTLE (0069-5800-61)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5810-60	60 CAPSULE in 1 BOTTLE (0069-5810-60)	1999-10-01
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5810-61	14 CAPSULE in 1 BOTTLE (0069-5810-61)	1999-10-01

Tikosyn (dofetilide) Suppliers: API and Finished-Dose Procurement Map

Last updated: April 25, 2026

Who supplies the tikosyn finished product?

Tikosyn is marketed as a branded, prescription-only oral antiarrhythmic (dofetilide). In the US, the brand’s supply chain is tied to the label holder and its commercial operations, with finished-dose availability typically distributed through national wholesalers and specialty distributors. The supplier set for procurement is therefore defined by (1) the marketing authorization holder (labeler), (2) the contract manufacturers that build and package the tablets for that labeler, and (3) the distribution network serving US accounts.

Procurement-relevant supplier classes for TIKOSYN (dofetilide)

• Labeler/Marketing authorization holder: sets finished-dose sourcing strategy and contracts with contract manufacturing organizations (CMOs) and packaging lines.
• CMOs (tablet manufacture): produce dofetilide tablets under GMP for the labeler.
• Packaging and labeling suppliers: provide blistering, bottle filling, carton/labelling, and cold-chain is not typically implicated for tablets.
• Wholesalers and specialty distributors: fulfill demand to pharmacies, hospitals, and specialty channels (availability varies by lot and distribution agreements).

Which suppliers make the dofetilide API?

Dofetilide is a specialized, high-cost-to-manufacture API with limited qualified supplier sets globally. For procurement planning, the practical approach is to track:

• DMF-linked API manufacturers (API producers named in regulatory submissions and referenced by the finished-dose labeler)
• Commercial API vendors that have a track record supplying branded dofetilide to the labeler
• Late-stage synthesis and salt-form processing suppliers that provide the API intermediate and final dofetilide substance

API supply profile for tikosyn (dofetilide) procurement

• API form: dofetilide (solid API used to produce tablets)
• Manufacturing mode: batch chemical synthesis, GMP release to DMF/MAH specifications
• Qualification requirement: routine supplier qualification via quality agreements, CoA, and stability bridging as required for any change

What dosing strengths exist for TIKOSYN and how that affects sourcing?

Tikosyn is sold in fixed tablet strengths used for dose initiation and titration:

Strength (tablet)	Typical role in therapy	Sourcing impact
250 mcg	lower starting dose	packaged in specific tablet configuration; often managed as a distinct finished-dose SKU
500 mcg	higher starting dose	separate SKU; may use different blister/bottle packaging lines

(Strength information is embedded in the US product labeling and packaging configurations; procurement should treat each strength as a separate supply line.)

What are the procurement “supplier touchpoints” for branded tikosyn?

For business teams building sourcing plans, demand continuity, or tender bids, the supplier landscape can be managed through a fixed set of touchpoints:

1. Brand labeler (MAH/labeler)
   Controls finished-dose supply allocation, lead-time commitments, and direct CMO contracting.

2. Contract manufacturing organizations (CMOs) for tablets
   Responsible for tableting, coating (if applicable), in-process controls, and GMP batch release.

3. Packaging and secondary packaging vendors
   Provide blistering or bottle filling, labeling, and carton packing to approved artwork and lot coding.

4. Qualified API suppliers
   Provide dofetilide API substance to the labeler’s approved manufacturing sites. API supply changes usually require regulatory and quality bridging.

5. US wholesalers/specialty distributors
   Provide the practical procurement channel for dispensing entities. Allocation and backorders can occur at lot level.

What procurement constraints apply specifically to tikosyn?

Tikosyn supply is constrained by the combination of:

• Highly controlled formulation and dosing (small therapeutic margin drives strict quality release standards)
• API scarcity dynamics (limited qualified suppliers for niche APIs)
• Regulatory traceability (batch traceability and lot-specific release expectations)
• Continuous quality oversight (supplier qualification, periodic review, and change control)

This makes substitution at the finished-dose level non-trivial and drives purchase decisions around:

• lot availability,
• distributor inventory position,
• and confirmation of correct NDC/strength.

Actionable supplier mapping for procurement teams

Because tikosyn procurement is dominated by branded finished-dose distribution and labeler-controlled manufacturing, the supplier map you actually need for sourcing decisions is structured as follows:

A) Finished-dose procurement (what to buy)

• Buy via authorized US distribution channels for each required strength.
• Treat NDC-specific inventory as the unit of supply management, not “brand name” generically.

B) Back-end supply risk management (how it’s made)

• Identify:
  • the tablet manufacturing site(s) (CMOs used by the labeler),
  • the packaging site(s),
  • and the API manufacturer(s) linked to the labeler’s approved supply chain.
• For vendor risk review:
  • confirm GMP status,
  • check quality history (OOS rates, recalls, warning letters if any),
  • and validate capacity to cover demand during periodic shutdowns.

Key Takeaways

• Tikosyn procurement is a labeler-controlled finished-dose supply system: tablets are manufactured and packaged under GMP by contracted sites, then distributed via authorized wholesalers and specialty channels.
• API supply for dofetilide is limited and qualification-driven: supplier qualification hinges on regulatory linkage, quality agreements, and batch traceability.
• Strength is a supply line: 250 mcg and 500 mcg are distinct SKUs with separate availability and distribution impacts, even though both are dofetilide tablets.
• Your actionable supplier shortlist is constrained to (1) labeler/MAH, (2) tablet CMO, (3) packaging CMO, (4) qualified API vendor(s), and (5) authorized distributors.

FAQs

1) Is the supplier set for TIKOSYN the same worldwide?
No. Procurement channel and qualified manufacturing/packaging sites differ by country regulatory submissions and distribution agreements.

2) Can pharmacies substitute TIKOSYN with other dofetilide tablets without brand-level sourcing controls?
Finished-dose substitution depends on availability of equivalent products and NDC-specific inventory control; branded tendering typically requires brand- and strength-specific supply verification.

3) What most often causes TIKOSYN backorders?
Allocation at distributor level linked to manufacturing batch timing, lot release, and API supply constraints.

4) How should procurement teams evaluate supplier risk for a niche API like dofetilide?
Focus on GMP qualification status, quality history, change control compliance, and capacity continuity at the API and tablet/packaging manufacturing sites.

5) Does TIKOSYN require special storage conditions that change supplier selection?
Tablet products are typically stored at controlled room temperature; supplier selection is mainly driven by GMP and supply availability rather than cold-chain capability.

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References

[1] FDA. “TIKOSYN (dofetilide) Prescribing Information.” U.S. Food and Drug Administration.
[2] FDA. “Drug Approval Package: TIKOSYN (dofetilide).” U.S. Food and Drug Administration.