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Suppliers and packagers for ADVIL ALLERGY SINUS
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ADVIL ALLERGY SINUS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL ALLERGY SINUS | chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 021441 | NDA | Haleon US Holdings LLC | 0573-0188-10 | 20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK | 2002-12-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Advil Allergy Sinus (ibuprofen/pseudoephedrine/antihistamine/caplets): key manufacturers, API and packaging supply chain, and regulatory sourcing
Advil Allergy Sinus is a private-label brand line built from a fixed-dose mix of common over-the-counter (OTC) actives. The supplier landscape is dominated by US-based OTC formulation packagers, global API producers for each active ingredient, and contract manufacturers that handle final dosage assembly and secondary packaging under US label ownership.
Advil Allergy Sinus supplier map (how sourcing typically works)
- Label holder / marketer: the branded product is marketed in the US under the Advil name; private-label and OTC retail shelf supply depends on seasonality and retail program allocation.
- API suppliers: multiple qualified sources typically exist for each active ingredient (ibuprofen, pseudoephedrine, antihistamines such as triprolidine/chlorpheniramine, and/or expectorant ingredients depending on the exact SKU and region).
- Formulation and dosage suppliers (co-manufacturers): OTC packagers and tablet/caplet manufacturers produce finished goods from supplied APIs and excipients.
- Packaging suppliers: blister, bottle, carton, and unit-dose packaging suppliers support compliance labeling and shelf stability requirements.
What this means for “suppliers” in practice For an OTC combination like Advil Allergy Sinus, there is rarely a single supplier. Purchases flow through:
- API procurement from qualified manufacturers,
- contract finished-dose manufacturing,
- packaging and labeling (including barcode, lot traceability, and child-resistant packaging where required),
- distribution under the brand owner’s logistics network.
What companies supply the APIs in Advil Allergy Sinus?
Answer (typical sourcing): multiple global API producers supply each active ingredient; the final supplier count depends on the specific Advil Allergy Sinus SKU and strength (capsule vs caplet, single-ingredient vs combination, and whether the antihistamine is triprolidine or chlorpheniramine).
Common actives in “Advil Allergy Sinus” OTC variants These products are commonly positioned around:
- NSAID: ibuprofen
- Decongestant: pseudoephedrine (often as pseudoephedrine HCl)
- Antihistamine: often an OTC first-generation antihistamine such as triprolidine or chlorpheniramine
- Other possible OTC adjuncts: some SKUs include additional actives; exact composition varies by market and formulation revision.
API supplier identification method used in industry Supplier lists for OTC combinations are usually reconstructed from:
- ANDA/505(b)(2) drug master data (if any generic equivalents exist for the same actives and forms),
- FDA drug listing and inspection histories for API plants (for plants manufacturing the actives),
- commercial sourcing databases and quality agreements used by OTC packagers.
Because Advil Allergy Sinus is OTC, public-facing supplier names for the finished product are often not published in a consolidated way. The workable approach is to identify API manufacturers for each active and then identify finished-dose packagers that assemble the final caplet/tablet and package under the Advil brand.
Which contract manufacturers produce Advil Allergy Sinus finished tablets or caplets?
Answer (typical sourcing): OTC contract manufacturers and packagers handle caplet/tablet manufacturing plus blistering/bottling and carton packing under brand owner supply agreements.
Finished dosage manufacturing supply-chain components
- Tablet/caplet compression or encapsulation line
- Granulation and blending (or direct compression depending on the formula)
- Coating for caplets (film coating) if applicable
- In-process controls for dissolution, assay, and blend uniformity
- Packaging:
- blister packs for unit retail display
- HDPE bottles with desiccant where stability requires
- lot traceability and tamper-evident seals
Where supplier names usually show up
- FDA facility inspection outcomes (establishment name appears by manufacturing site)
- Public inspection reports tied to facility establishment numbers
- OTC labeling master files in quality documentation (not always public)
What packaging suppliers support Advil Allergy Sinus retail bottles and blister packs?
Answer (typical sourcing): packaging suppliers provide bottles, closures, blister components, cartons, and labeling services. The main qualification criteria are traceability and regulatory compliance (label legibility, tamper evidence, child-resistant packaging where applicable).
Packaging categories
- Primary packaging: blister packs or HDPE bottles
- Closure systems: child-resistant caps where required; induction seals
- Secondary packaging: cartons with National Drug Code (NDC) labeling and dosage instructions
- Label print: barcode and lot-coded labels
Supplier qualification criteria
- Visual inspection standards and line clearance
- Migration and extractables testing for bottle/blister materials
- Stability compatibility with tablet/caplet coatings and excipients
How does supplier sourcing work for OTC combination drugs like Advil Allergy Sinus?
Answer: The brand owner or its OTC operations team manages supply continuity through multi-source qualification for each critical raw material and then books finished-dose and packaging capacity through qualified CMOs.
Key drivers
- Seasonal demand swings: winter cold season drives capacity planning.
- API supply constraints: pseudoephedrine-related supply is often capacity- and regulatory-sensitive.
- Quality systems: uniformity and stability specs require tested excipient blends and coating systems.
- Regulatory compliance: OTC products require GMP and lot traceability at each step.
What regulatory filings identify suppliers for Advil Allergy Sinus in the US?
Answer (typical): public identifiers for manufacturing sites are more visible at the facility level than at the brand level for OTC products. Brand owners usually register manufacturing establishments through FDA systems; those establishment names can be used to map supplier sites.
Regulatory artifacts used by analysts
- FDA establishment listings for manufacturing and packaging
- Drug labeling/NDC directories
- Facility inspection reports
- Remedy or consent decree records when applicable
Which suppliers are most likely constrained for Advil Allergy Sinus?
Answer (typical constraints):
- Pseudoephedrine API supply is the usual bottleneck in OTC decongestant combinations due to procurement controls and regulated distribution.
- Finished-dose capacity in caplet lines can be constrained during peak season.
- Packaging components can face lead-time constraints for blister and closure systems.
What is the generic entry risk if Advil Allergy Sinus actives go off-patent?
Answer: For OTC combinations, the “supplier risk” is often more about formulation and manufacturing equivalency than active ingredient patent life. Competitive entry depends on:
- ability to source APIs reliably,
- achieving bioequivalence/quality equivalence (for scaled approvals),
- consumer shelf acceptance.
Patent strategy matters less in OTC multi-active fixed-dose products, where copies compete through distribution and manufacturing capability rather than breakthrough IP.
Key Takeaways
- Advil Allergy Sinus sourcing is a multi-tier, multi-source supply chain: API manufacturers for each active plus contract finished-dose manufacturers and packaging suppliers.
- The most supplier-sensitive component is typically the pseudoephedrine API supply chain.
- Publicly identifying specific “supplier names” for the finished branded OTC product is usually done by mapping FDA-registered manufacturing and packaging establishments rather than relying on one official brand supplier list.
FAQs
1) How can I identify the manufacturing sites for Advil Allergy Sinus?
By mapping FDA-registered manufacturing/packaging establishments tied to the product’s NDC and then cross-referencing inspection records.
2) Which active ingredient supply chain is usually the limiting factor for OTC allergy sinus combinations?
Pseudoephedrine API procurement and regulated distribution are typically the constraints.
3) Are there dedicated blister and bottle suppliers for OTC caplets like Advil Allergy Sinus?
Yes, packaging is handled by qualified blister/bottle vendors with extractables and stability compatibility work and lot traceability capabilities.
4) Do OTC combination products use single-source API procurement?
Rarely. Multi-source qualification is standard to manage seasonal demand and supply disruptions.
5) Does patent expiration materially affect supplier availability for Advil Allergy Sinus?
In OTC, supplier availability is driven more by qualified manufacturing and quality equivalency than by patent-driven exclusivity for many fixed-dose combinations.
References
- U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DELM) and inspection-related facility information. FDA.
- FDA. NDC Directory and product listing resources. U.S. FDA.
- FDA. Current Good Manufacturing Practice (cGMP) for human drugs. U.S. FDA.
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