Last updated: May 26, 2026
ZYRTEC-D 12 HOUR Suppliers (cetirizine + pseudoephedrine) for Contract Manufacturing and API Procurement
Executive summary: ZYRTEC-D 12 HOUR is a fixed-dose combination of cetirizine (antihistamine) and pseudoephedrine (nasal decongestant). Supply chain sourcing typically breaks into two separable lanes: (1) API procurement for cetirizine and pseudoephedrine and (2) finished-dosage manufacturing for the extended-release combination tablet. Supplier lists are often fragmented by regulatory role (API producer vs. toll/CMO vs. packaging and distribution) and by strength and release profile (12-hour ER). Reliable supplier identification requires tying the product’s market authorization and label/manufacturing sites to specific companies; without that linkage, supplier names can be incomplete or wrong.
What companies supply the APIs for ZYRTEC-D 12 HOUR (cetirizine and pseudoephedrine)?
Direct API-supplier identification for a specific branded fixed-dose ER combination depends on the manufacturer named on the US label and the DMF/CEP pathway used for each API. In practice, the API lane for cetirizine and pseudoephedrine usually includes:
- Cetirizine dihydrochloride API makers (multi-kilo producers; commonly globalized supply)
- Pseudoephedrine hydrochloride API makers (restricted supply chain, with compliance controls)
Commercial reality: Many firms sell APIs into multiple markets, and brands often source through authorized distributors rather than directly contracting. A “supplier list” that is not anchored to the branded product’s actual labeled manufacturing site risks listing firms that supply other cetirizine or pseudoephedrine products but not the ZYRTEC-D 12 HOUR commercial blend.
Cetirizine API sourcing: what does an ER combination tablet require?
For a 12-hour tablet, API quality must support:
- Particle size and polymorph control (critical for ER uniformity)
- Salt form consistency (cetirizine dihydrochloride)
- Content uniformity across extended-release matrices
Pseudoephedrine API sourcing: what does a decongestant add to compliance?
Pseudoephedrine sourcing requires:
- Strict recordkeeping and supply controls due to regulated precursor handling
- Robust chain-of-custody documentation to satisfy distributor and regulator requirements
- Salt form control (commonly hydrochloride)
Which contract manufacturers make ZYRTEC-D 12 HOUR tablets (finished dosage) under tolling or CMO arrangements?
The finished-dosage supplier for ZYRTEC-D 12 HOUR is the labeler/manufacturer responsible for:
- Blending
- Granulation or matrix formation (for ER behavior)
- Compression/tableting
- Film coating (if applicable)
- Packaging (bottles and cartons)
- Release testing and QMS oversight
What to check to identify the CMO/finished-dose manufacturer
A credible supplier mapping typically comes from:
- US prescription label “Manufactured for” / “Manufactured by” line
- NDC labeler/manufacturer listing
- Inspection history of the manufacturing site tied to the labeled product
Without the label-to-site mapping, any company names provided would not be anchored to the specific ZYRTEC-D 12 HOUR product.
What packaging and distribution suppliers support ZYRTEC-D 12 HOUR (bottles, labels, logistics)?
For branded Rx combo products, the packaging and distribution stack often splits into:
- Packaging operations (bottle filling, seal, carton pack-out)
- Serialization and track-and-trace compliance where applicable
- 3PL logistics for cold-chain only if temperature control is required (typically not for ER tablets)
A supplier list that covers only “tablets” ignores the actual operational bottleneck often found in bottle supply, label printing/verification, and distribution readiness.
How do you validate real ZYRTEC-D 12 HOUR suppliers for procurement (DMF, cGMP sites, and regulatory linkages)?
For procurement-grade supplier validation, the actionable steps are:
- Tie the branded product to the cGMP manufacturing site named on labeling
- Confirm each API has a corresponding quality dossier (DMF listing or equivalent regulatory pathway)
- Verify whether supply is direct-labeled (API producer named) or distributor-mediated
In many cases:
- The brand’s labeled manufacturer handles downstream operations (tablet and packaging).
- API is sourced from multiple upstream producers, with at least one approved supply source at the dossier level.
What are the major supplier risks for ZYRTEC-D 12 HOUR (single-source, ER tech, and pseudoephedrine constraints)?
Key risk categories that affect supplier strategy:
- ER formulation technology bottlenecks (matrix control, dwell times, and coating process)
- Site capacity concentration (one or two qualified sites for finished product)
- Pseudoephedrine upstream controls (restricted precursor supply chain and documentation)
- Regulatory compliance drift (cGMP inspection outcomes drive supply qualification)
These risks usually determine whether a company can qualify an alternate CMO quickly.
Supplier landscape: how do ZYRTEC-D 12 HOUR and related cetirizine ER products typically compare?
Brands in the cetirizine ER + decongestant segment often share:
- Similar upstream API inputs
- Different downstream ER matrix approaches (affects CMO selection)
- Different packaging configurations (affects primary and secondary packaging suppliers)
Procurement comparisons should be limited to products with the same release profile and tablet architecture, otherwise CMO qualification does not transfer.
Key Takeaways
- ZYRTEC-D 12 HOUR supply chain has two supplier lanes: cetirizine and pseudoephedrine APIs, plus a finished-dosage tablet manufacturer and packaging partner.
- Credible supplier naming requires product-to-site linkage using the label/manufacturer and NDC mapping; otherwise, “supplier lists” can be inaccurate for the specific branded product.
- Pseudoephedrine adds supply-chain compliance constraints that can limit qualified upstream sources and slow alternate procurement.
- ER manufacturing is the usual differentiator for CMO selection because matrix and coating performance drive content uniformity and release behavior.
FAQs
- How can I identify the actual manufacturer of ZYRTEC-D 12 HOUR from the NDC labeler/manufacturer line?
- Do ZYRTEC-D 12 HOUR suppliers differ for the API versus the extended-release tablet manufacturing?
- What documents typically support API supplier qualification for cetirizine and pseudoephedrine in an Rx combination product?
- What manufacturing parameters control extended-release performance in cetirizine + pseudoephedrine tablets?
- How do pseudoephedrine precursor restrictions affect second-source qualification for API and finished goods?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA. Drug Master Files (DMF) program overview. (Accessed via FDA DMF information).
- FDA. cGMP requirements for finished pharmaceuticals and inspections. (Accessed via FDA cGMP guidance pages).
