Suppliers and packagers for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704	NDA	Chattem, Inc.	41167-4320-5	2 BLISTER PACK in 1 CARTON (41167-4320-5) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704	NDA	Chattem, Inc.	41167-4320-7	3 BLISTER PACK in 1 CARTON (41167-4320-7) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03

Suppliers and packagers for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Last updated: June 3, 2026

ALLEGRA-D 24 Hour Allergy and Congestion suppliers: API, finished-dose, and logistics landscape

ALLEGRA-D 24 Hour is a branded, extended-release combination of fexofenadine hydrochloride (H1 antihistamine) and pseudoephedrine sulfate (decongestant). Suppliers typically fall into three layers: (1) API manufacturers, (2) formulation/excipient and controlled-release excipient suppliers, and (3) contract manufacturers (CDMOs) for finished-dose tablets.

No complete, authoritative “supplier list” can be produced from the information provided, because finished product supply is not reliably disclosed at the level of named upstream vendors for this specific brand. An actionable supplier map requires company-by-company source-to-market confirmation for each layer, and those data are not contained in the prompt.

What companies supply fexofenadine hydrochloride and pseudoephedrine sulfate for combination products like ALLEGRA-D 24 Hour?

Core actives in ALLEGRA-D 24 Hour

• Fexofenadine HCl
• Pseudoephedrine sulfate

Supplier archetypes for each API

1. API manufacturers that produce fexofenadine and pseudoephedrine salts
2. Salt-forming and conversion supply chains (where the API is isolated and converted to the marketed salt form)
3. Verification supply for quality systems, DMFs/ASMF referencing, and commercial supply continuity

API supply risk drivers

• Regulatory documentation availability (DMF/ASMF access and cross-referencing)
• Quality system maturity (GMP inspection history)
• Capacity availability for extended-release tablets (supply needs often align with seasonal allergy demand)

What most buyers do

• Use the Orange Book / FDA listing as a starting point for finished-dose manufacturing details, then map upstream API and excipient sources through DMF holders, ASMF holders, supplier qualification packages, and CDMO documentation.

Which contract manufacturers make extended-release tablets for fexofenadine plus pseudoephedrine combinations?

Finished-dose CDMO supplier categories

• Tablet compression and coating manufacturers
• Extended-release technology providers (matrix systems or membrane-controlled systems, depending on formulation)
• Packaging and secondary assembly suppliers (blistering and unit-dose logistics)

Key selection criteria

• Experience with combination extended-release oral solid dosage forms
• Control of release profile and content uniformity
• Ability to supply GMP release testing and stability programs for shelf-life claims

What excipient and controlled-release material suppliers support 24-hour allergy and congestion tablets?

ALLEGRA-D 24 Hour is an extended-release tablet, which typically requires supplier-qualified:

• Extended-release polymers/matrix components
• Coating and film-formers
• Lubricants, binders, disintegrants, and stabilizers
• Specialized excipients used to control drug release rate across 24 hours

Supplier intent for excipient selection

• Consistent dissolution behavior across commercial lots
• Compatibility with both actives, including salt-form stability and hygroscopicity management
• Supply continuity for seasonal peak demand

What patent estate and FDA status affect who can supply ALLEGRA-D 24 Hour?

A practical supplier strategy depends on whether the product is:

• Brand-only with limited generic competition
• Subject to formulation and method patents that block direct generic entry
• Subject to FDA exclusivity or ongoing patent litigation that affects supply agreements

For ALLEGRA-D 24 Hour specifically, supplier mapping typically also uses:

• FDA drug listing (established name, dosage form, NDA holder/manufacturer details)
• Orange Book patent coverage (listed patents for formulation, method-of-use, or manufacturing changes)

When does ALLEGRA-D 24 Hour lose exclusivity, and how does that change the supplier landscape?

Supplier change usually tracks one or more of:

• Patent expiry or expiration of last-protecting claim(s)
• Loss of regulatory exclusivity (data exclusivity, marketing exclusivity)
• Successful ANDA approval and market entry by multiple generics

Once generics enter, supply becomes less concentrated, with:

• More qualified API sources competing
• More CDMOs bidding on commercial manufacturing capacity
• More packaging suppliers participating in expanded distribution volumes

What generic entry risks exist for fexofenadine plus pseudoephedrine extended-release tablets?

Common barriers that can limit generic supplier qualification:

• Inability to match the brand extended-release dissolution profile
• Formulation patent coverage that requires design-around
• Manufacturing process dependencies (granulation, compression parameters, coating process)
• Hold-up from Paragraph IV litigation (for ANDAs filed with patent challenges)

How strong is the patent estate for fexofenadine/pseudoephedrine extended-release products?

The patent estate strength for a specific brand depends on:

• Number of listed Orange Book patents
• Whether they are formulation, method-of-use, or process-related
• Remaining term for the last-to-expire claim

A strong estate correlates with:

• Fewer generic launch opportunities
• Continued brand dominance and tighter supplier relationships

How does ALLEGRA-D 24 Hour compare with other fexofenadine plus pseudoephedrine brands in supplier and manufacturing structure?

Comparison points that matter for supplier mapping:

• Dosage form: extended-release tablet versus other release profiles
• Strengths and salt forms
• Listed patent coverage in the Orange Book
• Whether alternative brands use the same CDMO/API sources or different supply chains

What litigation and settlements affect supply agreements for ALLEGRA-D 24 Hour?

Patent litigation can affect:

• Which generics are allowed to launch
• Which manufacturing sites are used
• Whether supplier contracts require interim supply covenants or design-around changes

For supplier due diligence, buyers focus on:

• Court dockets for ANDA cases tied to the drug’s Orange Book list
• Settlement agreements that define launch timing and generic design boundaries

What is the Orange Book status of ALLEGRA-D 24 Hour, and where is it manufactured?

The Orange Book can identify:

• NDA holder
• Dosage form codes
• Listed patents
• Patent expiration timing and coverage scope

Manufacturing site details, when present, help identify:

• Finished-dose site suppliers
• Packaging/manufacturing responsibility structures

Who are the leading suppliers to the US market for fexofenadine APIs and pseudoephedrine APIs used in combination products?

A defensible named list of suppliers requires sourcing from:

• DMF/ASMF holder registries
• Supplier qualification disclosures
• FDA references in filings and correspondence
• Public GMP inspection and consent decree records
• Commercial procurement disclosures (vendor qualification data)

That specific vendor-to-brand attribution is not provided in the prompt, so it cannot be completed accurately here.

Key supplier due-diligence checklist for ALLEGRA-D 24 Hour purchasing teams

1. Map upstream actives: fexofenadine HCl and pseudoephedrine sulfate supply qualification and documentation.
2. Confirm extended-release formulation excipient strategy and sourcing controls.
3. Validate CDMO capability for 24-hour release tablets and appropriate process parameters.
4. Cross-check Orange Book patent coverage relevant to formulation/process and ensure compliant generic or re-manufacturing paths.
5. Require batch-level analytics and dissolution profiles for release equivalence.

Key Takeaways

• ALLEGRA-D 24 Hour is a fexofenadine HCl + pseudoephedrine sulfate extended-release oral solid product.
• The supplier universe is segmented into API sources, excipient/controlled-release suppliers, and finished-dose CDMOs/packagers.
• A named “suppliers for ALLEGRA-D 24 Hour” list cannot be produced from the prompt because the data needed to attribute specific upstream vendors to this branded product are not provided.
• The actionable method is to anchor to FDA product listing and Orange Book patent coverage, then map upstream sources through DMF/ASMF and qualified vendor documentation.

FAQs

1. How do I identify the API DMF holders for fexofenadine HCl and pseudoephedrine sulfate used in extended-release combination tablets?
2. What excipients most often control the 24-hour dissolution profile in fexofenadine/pseudoephedrine extended-release tablets?
3. How do Orange Book formulation patents affect ANDA supplier qualification for fexofenadine plus pseudoephedrine products?
4. What manufacturing process parameters drive content uniformity and dissolution equivalence in extended-release pseudoephedrine-containing tablets?
5. When multiple generics enter fexofenadine/pseudoephedrine combination markets, how does the API supplier pool typically change?

References

No cited sources were provided in the prompt.