Last updated: April 24, 2026
Who Supplies ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION?
ALLEGRA-D 12 Hour Allergy and Congestion is a brand combination product containing fexofenadine (HCl) 60 mg and pseudoephedrine (HCl) 120 mg per tablet (extended release), marketed in the U.S. under the Sanofi brand umbrella. Supply chain participants for finished product and key API inputs are set by the brand owner’s commercial strategy and contract manufacturing arrangements. For “ALLEGRA-D 12 HOUR,” the most decision-relevant supplier set is: (1) brand owner and labeler, (2) listed contract manufacturer(s) for finished-dose product, and (3) upstream API manufacturers for fexofenadine and pseudoephedrine.
What is the product and labeler that drive supplier identification?
The product’s label identifies the brand and legal manufacturer/marketer ecosystem that governs which facilities supply the finished dose to wholesalers and pharmacies.
| Field |
Value |
| Product name |
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION |
| Core actives |
Fexofenadine HCl 60 mg + Pseudoephedrine HCl 120 mg (extended release) |
| Product type |
Oral extended-release combination tablet |
| U.S. labeler / brand owner |
Sanofi |
Source: U.S. prescribing information and product labeling for ALLEGRA-D 12 Hour (fexofenadine and pseudoephedrine combination tablet) [1].
Which companies are the finished-dose manufacturing suppliers?
Finished-dose suppliers for branded products are typically disclosed on U.S. product labeling as the manufacturer or site-specific entity. For ALLEGRA-D 12 Hour, the prescribing information and FDA label typically identify the company responsible for manufacturing and distributing the product under the Sanofi brand.
| Supplier role |
Supplier (company) |
Evidence |
| Finished-dose manufacturer / label manufacturing entity |
Sanofi (brand owner; manufacturing is performed under Sanofi label arrangements) |
ALLEGRA-D 12 Hour U.S. label identifies the company under which the product is marketed and manufactured/distributed [1] |
Note: A facility-by-facility supplier list (site addresses and specific third-party contract manufacturing organizations) is not reliably extractable from the single high-level product label alone; those details must come from label “Manufactured for” blocks and/or the underlying FDA product listing for the specific NDC configuration.
Who supplies the APIs (fexofenadine and pseudoephedrine) upstream?
Upstream API suppliers are often disclosed through DMF-to-manufacturer linkages, supplier qualification disclosures, or in some cases in the prescribing information (rare for combination brands). For fexofenadine and pseudoephedrine, the supplier set is generally governed by a limited number of API producers and intermediates suppliers that are qualified to produce to the brand’s specifications.
| API |
Typical supplier set in industry |
Evidence basis |
| Fexofenadine HCl |
Specialized antihistamine API producers with DMF/ANDA API dossiers |
API supplier identification is usually DMF-based, not listed in general product label [1] |
| Pseudoephedrine HCl |
Large-scale controlled-substance upstream producers and salt-formers |
Typically not enumerated in consumer-level label; controlled-substance handling governs sourcing [1] |
Hard constraints: Without the DMF/Reference Listed Drug linkage, FDA Orange Book entry details, and/or verified NDC-to-manufacturer blocks, listing named upstream API suppliers risks accuracy failures. The only supplier set that is consistently supported by the publicly cited product label is the labeler/brand owner entity (Sanofi) and the product’s actives and composition.
Supply chain map that procurement can execute
How does a supplier list become “actionable” for ALLEGRA-D 12 HOUR?
Procurement and R&D vendor qualification should treat the supplier universe as three tiers:
-
Brand owner / labeler (commercial gatekeeper)
- Controls label specifications, changes, and quality systems for the finished dose.
- For this product, the label ecosystem is Sanofi [1].
-
Finished-dose manufacturing entity
- The company named in the “Manufactured for” / “Manufactured by” section on the specific U.S. label/NDC.
- This is the entity that signs supply and quality agreements for tablets.
-
API and intermediate manufacturers
- Must be aligned to DMF specifications and validated process controls.
- For this product, the APIs are fexofenadine HCl and pseudoephedrine HCl [1].
Key product facts that determine the supplier requirements
What specs constrain which suppliers can make ALLEGRA-D 12 HOUR?
| Constraint |
Why it matters |
| Combination ER formulation |
Requires controlled-release tablet technology and validated release profile. |
| Controlled substance supply chain |
Pseudoephedrine sourcing and handling is regulated, limiting supplier eligibility. |
| Two-API manufacturing coordination |
Timing, segregation, and validation across two APIs in a single ER dosage form. |
| Label-linked specifications |
API identity, impurity thresholds, and dissolution specs must match the labeled product. |
Source: Product labeling for ALLEGRA-D 12 Hour includes active ingredients and their strengths [1].
Key Takeaways
- ALLEGRA-D 12 HOUR is a Sanofi brand combination tablet with fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg (extended release) [1].
- A procurement-grade supplier list requires the finished-dose manufacturer entity named on the specific U.S. label/NDC and, for upstream sourcing, DMF/Orange Book linkage for fexofenadine and pseudoephedrine (the public product label alone does not enumerate named API producers).
- The most defensible supplier anchor available from publicly cited labeling is Sanofi as the brand owner and label ecosystem for the finished product [1].
FAQs
-
Who owns ALLEGRA-D 12 HOUR?
The U.S. brand owner/label ecosystem is Sanofi [1].
-
What are the active ingredients in ALLEGRA-D 12 HOUR?
Fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg (extended release) [1].
-
Does the public product label list the specific contract manufacturer facility?
The high-level labeling identifies the label ecosystem (Sanofi) but may not enumerate every facility and contract manufacturer in a way that supports a precise supplier roster from the label alone [1].
-
Are API suppliers publicly listed in the labeling?
Typically not for branded combination ER products; upstream API supplier identification usually requires DMF/Orange Book/NDC-manufacturer mapping rather than consumer label text [1].
-
What upstream APIs must be sourced for ALLEGRA-D 12 HOUR?
Fexofenadine HCl and pseudoephedrine HCl [1].
References (APA)
[1] Sanofi. (n.d.). ALLEGRA-D 12 Hour allergy and congestion (fexofenadine HCl and pseudoephedrine HCl) prescribing information / product labeling (U.S. label).
