Last updated: May 29, 2026
XYZAL Allergy 24HR (levocetirizine) Supplier Landscape and Contract Manufacturing Footprint
Executive summary: Xyzal Allergy 24HR is the brand for levocetirizine dihydrochloride oral antihistamine. The supply chain is dominated by (1) API manufacturers supplying levocetirizine dihydrochloride, (2) finished-dose contract manufacturers (CMOs) producing tablets/caps or oral solids for multisource branding under approved ANDA/bridging arrangements, and (3) packaging and secondary distribution vendors. Final supplier identification depends on the specific labeled presentation (strength and dosage form) and the US NDC in use; these details determine which CMOs appear in FDA manufacturing listings and labeling.
Who supplies XYZAL Allergy 24HR (levocetirizine) in the US?
Direct answer: XYZAL is marketed by Sanofi in the US, with finished-dose production typically handled by Sanofi’s manufacturing network and qualified CMOs. API supply for levocetirizine dihydrochloride is sourced globally from specialty chemical and API producers, and the exact API vendor for a given lot is not consistently public unless tied to specific FDA manufacturing site data, labeling supply chains, or DMF-linked disclosures.
What is “XYZAL Allergy 24HR” from an IP and regulatory standpoint?
- Active ingredient: levocetirizine dihydrochloride
- Therapeutic class: second-generation H1 antihistamine
- Indication: allergic rhinitis and allergy symptoms (OTC branding)
- Product form: oral solid (most commonly tablets/caps for “24HR” branding)
Which API manufacturers make levocetirizine dihydrochloride for branded products like Xyzal?
Direct answer: Levocetirizine dihydrochloride APIs are produced by multiple global suppliers that typically hold DMFs/EDMFs and supply to multiple branded and generic finished-dose manufacturers. The specific API supplier for “Xyzal Allergy 24HR” depends on the NDC’s manufacturing site assignments.
Common API supplier categories
- Specialty API firms with DMFs and controlled impurity profiles
- Generic API plants that support multiple strengths (e.g., 2.5 mg, 5 mg)
- Stewardship-linked suppliers who coordinate polymorph and impurity specs for regulatory compliance
How API supply shows up in practice
- API sites can be inferred from US FDA DMF/EDMF linkages and from finished product manufacturing site patterns.
- Finished-dose labeling and FDA facility listings can be used to connect production years to specific manufacturing locations.
Which companies manufacture XYZAL Allergy 24HR tablets or capsules (contract manufacturing)?
Direct answer: The finished-dose manufacturing is performed by Sanofi manufacturing sites and/or qualified contract manufacturers for solid oral dosage forms. The practical supplier list is best constructed from FDA facility registrations and labeling-associated manufacturing site disclosures for the specific NDC.
What to look for in FDA facility data
For each NDC presentation:
- Site name (tablet/capsule line)
- Address and ownership/affiliation
- Inspection and compliance history signals
- Whether the site is listed as the holder of manufacturing responsibilities for finished product
What packaging suppliers support XYZAL Allergy 24HR (bottles/blisters/secondary packaging)?
Direct answer: Packaging and secondary packaging are usually performed by specialty packaging vendors and/or integrated operations at the finished-dose manufacturer’s site. Public data rarely names packaging vendors unless:
- the vendor appears in DMF/CMC references or labeling/manufacturing site footnotes, or
- the packaging is performed at a distinct registered site for the NDC.
Packaging endpoints relevant to “24HR”
- Bottling lines
- Desiccant and induction seal integration (where used)
- Blister strip production (if presentation uses blistering)
- Cartoning and label application under OTC labeling rules
How do ingredient and manufacturing suppliers change across NDCs and strengths?
Direct answer: Supplier assignments can shift across:
- strength (e.g., 2.5 mg vs 5 mg)
- dosage form (tablet vs capsule if offered)
- pack size and labeling version
- country of manufacture and NDC refreshes
Supplier-shift drivers
- Capacity rebalancing across Sanofi plants
- CMOs onboarding for seasonal demand
- Regulatory remediation or inspection outcomes at specific plants
- Cost optimization via multiple qualified sites
What generic and OTC challengers are most likely to use the same supplier network?
Direct answer: Levocetirizine dihydrochloride generics and OTC antihistamine equivalents often rely on:
- common API suppliers,
- common solid oral CMOs with shared platform capabilities,
- and packaging vendors that serve multiple NDCs.
Competitive supply chain overlap
When generic entrants share the same CMO or API supplier, they may exhibit:
- similar impurity profiles and dissolution performance,
- similar excipient systems,
- and similar manufacturing constraints for solid oral scale-up.
Which regulatory filings identify supplier sites for levocetirizine products?
Direct answer: Supplier site identification for “XYZAL Allergy 24HR” is linked to:
- FDA drug application listings for manufacturing sites (finished product and packaging sites),
- DMF/EDMF submissions (API),
- and inspection records tied to registered establishments.
Orange Book and exclusivity linkage
- Xyzal is a prescription brand historically tied to patent exclusivity dynamics for levocetirizine.
- OTC “24HR” branding may correspond to a branded OTC label or transitioned authorized supply chain, while the regulatory traceability still flows through FDA listing and manufacturer registrations.
What does a supplier mapping plan look like for XYZAL Allergy 24HR?
Direct answer: The most actionable approach for procurement, partnering, or diligence is to map by NDC presentation, then connect:
- Finished product manufacturing sites registered with FDA for that NDC.
- Packaging sites associated with label application and secondary packaging.
- API linkage via DMF/EDMF registrations associated with the product’s approved application pathway.
Deliverable structure
- Table by NDC: dosage form, strength, manufacturer site, packaging site, country of manufacture
- API DMF/EDMF mapping: API supplier and submission type
- Inspection signals: dates and outcomes (where publicly available)
Key Takeaways
- Xyzal Allergy 24HR is levocetirizine dihydrochloride; suppliers split into API providers, finished-dose CMOs/manufacturers, and packaging vendors.
- The supplier list for “XYZAL Allergy 24HR” is NDC-specific; manufacturing site assignments can vary by strength, dosage form, and pack configuration.
- The most reliable public supplier mapping uses FDA manufacturing/establishment listings for the specific NDC, then connects API supply through DMF/EDMF linkages.
FAQs
- How can I identify the manufacturer of Xyzal Allergy 24HR for a specific NDC?
- Do levocetirizine generics use the same API suppliers as Xyzal?
- Which FDA database shows finished-dose manufacturing sites for Xyzal?
- How do packaging vendors appear in FDA listings for OTC antihistamines?
- What supplier changes typically occur when manufacturing capacity shifts for solid oral drugs?
References
- U.S. Food and Drug Administration. Drug Establishments Current Registration Site. (FDA database).
- U.S. Food and Drug Administration. Drugs@FDA. (FDA database).
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA database).
