Suppliers and packagers for chantix

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chantix

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0468-56	56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)	2006-05-10
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0469-28	56 TABLET, FILM COATED in 1 BLISTER PACK (0069-0469-28)	2006-05-10
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0469-56	56 TABLET, FILM COATED in 1 BOTTLE (0069-0469-56)	2006-05-10
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0471-28	1 KIT in 1 BLISTER PACK (0069-0471-28) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK	2006-05-10

Chantix (varenicline) Suppliers: API, CDMO, and Finished-Dose Manufacturing Landscape

Last updated: May 28, 2026

Executive summary

• Chantix is a branded varenicline tablet in the US (Pfizer).
• Supplier intelligence for “Chantix” depends on whether the question targets (1) the active pharmaceutical ingredient (API) “varenicline” supply chain or (2) contract manufacture of finished-dose varenicline tablets.
• A complete, accurate supplier list requires matching Pfizer’s US finished-dose source(s) and the underlying API manufacturers to specific plants tied to varenicline product lifecycle documents (FDA inspections/DMFs, labeling “manufactured for” lines, and Orange Book/Drug Registration and Listing files). With the information provided, a definitive supplier roster cannot be produced.

Which companies supply the Chantix (varenicline) API and finished tablets?

Direct answer

• Chantix is supplied through Pfizer’s branded product system. The exact contract API/CDMO roster must be confirmed plant-by-plant from regulatory and labeling sources.

What sources typically identify Chantix suppliers that matter commercially?

• US prescribing information and carton/labeler lines: “Manufactured for” and “Distributed by” statements identify finished-dose manufacturers and labelers for specific NDA/strengths.
• FDA Orange Book and NDA application ties: supports identification of manufacturing/holder structures, though it may not enumerate all API suppliers.
• FDA DMFs and ASMFs for varenicline: can identify API manufacturers, but mapping each DMF holder to the exact Chantix product source requires dossier-to-plant linkage.
• Inspection lists and 483 outcomes: can confirm whether a site is active in the varenicline supply chain for that product.
• Global regulatory filings (e.g., EMA, MHRA, CDSCO where applicable): can broaden supplier coverage beyond the US.

What does “supplier” mean in varenicline for a practical due-diligence checklist?

• API supplier(s) for varenicline (free base/salt form used for tablet manufacture)
• Finished-dose supplier(s) for varenicline tablets
• Secondary packaging and labeler (often a different entity)
• Sterility is not relevant (oral solid), but tablet blend/compression, coating, and packaging are key manufacturing steps

What patents protect Chantix (varenicline) and how does that affect who can supply?

Direct answer

• Patent protection affects market entry economics, not the identity of the supplier. Suppliers can change even when the brand remains protected, via contracts and plant transfers.

Why supplier lists must be separated from IP

• Contract manufacturing and API supply are operational decisions that can switch for cost, capacity, or compliance, even during patent life.
• IP scope (composition, process, polymorph, formulation) can influence which facilities can qualify or which suppliers can develop approved alternative sources.

Key patent estate inputs that influence supply qualification

• API manufacturing process patents (if claimed): can constrain alternative manufacturing routes.
• Solid form/polymorph claims: can constrain which material spec a supplier can deliver.
• Tablet formulation and coating claims: can constrain excipient systems and coating methods used in commercial lots.
• Method-of-use claims: typically do not affect manufacturing eligibility for generics, but they can affect regulatory and labeling strategies.

When does Chantix lose exclusivity and what does that do to supplier options?

Direct answer

• “Chantix exclusivity timelines” depend on the specific US exclusivity and patent term calculations for the NDA and any pediatric/market exclusivity extensions. A timeline requires dossier-specific expiration dates.

What to measure for supplier switching risk after exclusivity

• Generic entrance timing affects:
  • raw-material contracting leverage
  • price pressure on API and tablet manufacturing services
  • qualification needs for alternate solid form lots
• Even if exclusivity ends, FDA approval status and GMP compliance determine which suppliers can make and ship.

What is the Orange Book status of Chantix (varenicline) and who would qualify to supply?

Direct answer

• Orange Book status identifies covered patents listed for the relevant NDA and which generic applicants can make carve-outs. It does not directly enumerate all manufacturing suppliers.

What Orange Book fields translate into supplier strategy

• Patent listing types (drug substance, drug product, method-of-use)
• Expiration and any listed “use restrictions”
• Exclusivity codes and dates
• Any granted Paragraph IV exclusivity after ANDA challenges (where applicable)

What generics exist for varenicline, and how does that change the supplier landscape?

Direct answer

• The supplier pool typically broadens after generic launches because multiple ANDA holders can source from different API and tablet manufacturing sites, still subject to GMP and chemistry controls.

How to map generic holders to actual manufacturers

• ANDA labels include:
  • “Manufactured for” for each strength and NDC
  • sometimes the tablet manufacturer or primary packager
• API supplier identification then follows via DMF and site disclosure in inspections, where available.

What finished-dose manufacturing barriers affect who can supply Chantix tablets?

Direct answer

• For oral solid tablets, key barriers are:
  • consistent API solid form and impurity profile
  • tablet blend uniformity and dissolution specs
  • coating process control
  • change control and comparability data requirements
• These barriers do not uniquely identify one supplier, but they determine which CDMOs can qualify to supply varenicline tablets at commercial scale.

Key takeaways

• A definitive “suppliers for Chantix” list requires plant-level confirmation from labeling, FDA registrations, DMFs/ASMFs, and inspection records mapped to specific varenicline tablet strengths.
• With only the product name provided, a complete and accurate supplier roster cannot be produced without risking inaccuracies.
• Supplier identification must be split into API manufacturers and finished-dose tablet manufacturers, then validated against the exact NDC strength(s) and manufacturing/labeler lines.

FAQs

1. Who makes Chantix tablets in the US for Pfizer?
   Requires reading the product label “manufactured for” line tied to the specific NDC strength.

2. Which companies manufacture varenicline API for branded and generic tablets?
   Requires mapping FDA DMF/ASMF holders to approved drug substance use for specific NDA/ANDA products.

3. Are there multiple suppliers for varenicline API used across strengths or years?
   Typically yes, due to supply continuity and batch sourcing, but it must be confirmed by plant-level documents.

4. How do CDMOs qualify to produce varenicline tablets?
   Through GMP compliance plus specification control of API solid form, impurities, dissolution, and stability, with change-control comparability.

5. Do patent challenges change Chantix’s supplier list directly?
   They mostly change market entry and pricing; operational supplier lists can shift independent of patent status.

References

1. US FDA, Orange Book: Approved Drug Products (search for “Chantix” and “varenicline”).
2. US FDA Drug Registration and Listing (DRLS): NDC labeler/manufacturer information tied to Chantix NDC(s).
3. US FDA Prescribing Information / carton and immediate container labeling for Chantix (varenicline) identifying “manufactured for” and labeler/manufacturer lines.
4. US FDA DMF/ASMF database entries for varenicline (search “varenicline” and map holders to drug substance use).