Last updated: May 28, 2026
Claritin-D is an over-the-counter combination of loratadine (antihistamine) and pseudoephedrine (decongestant). Supply and manufacturing networks for Claritin-D are typically handled through a chain that includes API suppliers (loratadine and pseudoephedrine), contract manufacturers for finished dosage forms, and packaging and distribution partners. The available public record does not provide enough complete, source-cited specificity on the current named suppliers for the branded Claritin-D product (including which companies manufacture the finished tablets/capsules and which firms package the final commercial lots).
What companies supply the loratadine and pseudoephedrine APIs used in Claritin-D?
Answer (high level): The Claritin-D supply chain starts with loratadine API and pseudoephedrine HCl API from specialty chemical/API manufacturers, followed by contract manufacturing of the fixed-dose combination product.
Which firms commonly produce loratadine API for branded OTC products?
Common loratadine API production is concentrated among large-scale global API manufacturers with global GMP networks and established OTC tracks. Named sources are not consistently disclosed against the specific branded finished product “Claritin-D” in public filings, and OTC supply is often implemented via private commercial agreements.
Which firms commonly produce pseudoephedrine API for combination OTC decongestants?
Pseudoephedrine API is produced by a smaller set of suppliers due to regulatory controls and supply-chain constraints. Again, branded finished-product supplier names are not reliably mapped in public databases to “Claritin-D” specifically.
Who manufactures the finished dosage form for Claritin-D tablets/capsules?
Answer (high level): Finished dosage manufacturing for branded OTC combination products is often performed by contract manufacturing organizations (CMOs) under quality agreements, or by sites owned by the brand holder. Public supplier disclosure for “Claritin-D” at the finished-dose level is incomplete.
Are there contract manufacturers for OTC loratadine-pseudoephedrine combinations?
Yes, the segment uses both:
- CMOs producing fixed-dose combinations under NDA/quality agreements
- Branded-company plants for some market regions and time periods
But public sources rarely tie a specific CMO to the specific branded product label “Claritin-D” without clear linkage documents.
How do packaging suppliers fit into Claritin-D distribution?
Packaging supply typically includes:
- Bottle and carton supply
- Blister packaging (if applicable for specific SKUs)
- Printed labeling and lot-numbering systems
Public “label claim” data does not reliably identify the packaging supplier.
Which suppliers distribute Claritin-D in the US retail channel?
Answer (high level): Distribution is typically executed via:
- National wholesalers and direct-to-retail distribution networks
- Third-party logistics providers for regional stock management
The exact distributor listed on the retail packaging can vary by region and time, and public sources do not consistently identify the same entity across all Claritin-D SKUs.
What does the FDA listing show about Claritin-D manufacturing sites and firms?
Answer (high level): FDA datasets can show registered manufacturers and labelers for drug products, but mapping those entries to “suppliers” requires precise product identification and dataset extraction.
What does the labeler/NDAs/OTC listing typically indicate?
For OTC drugs, labeler and manufacturing site identifiers can be present in FDA product databases. However, without a complete and source-cited dataset for “Claritin-D” SKU-level entries, supplier names cannot be asserted.
How can buyers verify the exact Claritin-D supplier for procurement?
Answer (high level): Buyers verify via:
- Lot traceability on commercial packaging
- CoA documents (manufacturing site and testing site)
- FDA facility registration and drug establishment listings tied to the specific NDC and dosage form
The “Claritin-D” branded umbrella covers multiple NDCs, strengths, and formulations over time, making supplier identification dependent on SKU-specific verification.
What supplier constraints affect Claritin-D availability (pseudoephedrine controls and API sourcing)?
Pseudoephedrine supply is more constrained than loratadine due to regulation and controlled logistics. Supply risk tends to concentrate at:
- Pseudoephedrine API availability
- Conversion and salt formation steps (as applicable)
- Regulated distribution and inventory allocation
- Fixed-dose combination filling capacity
Key Takeaways
- Claritin-D is a loratadine + pseudoephedrine OTC fixed-dose combination; supply chains include API suppliers, finished-dose manufacturers/CMOs, and packaging/distribution partners.
- Public sources do not provide enough SKU-specific, source-cited identification of the named “Claritin-D suppliers” (finished-dose manufacturer, packaging provider, and distributor) to list exact companies.
- Accurate supplier identification for procurement requires NDC/SKU-level lot traceability and mapping to FDA establishment and product listing records.
FAQs
-
Which companies produce loratadine API for OTC fixed-dose products?
Loratadine API production is dominated by global API manufacturers, but branded “Claritin-D” mapping is not consistently disclosed in public records.
-
Who supplies pseudoephedrine API used in combination decongestant products?
Pseudoephedrine API is supplied by a limited set of regulated producers; branded finished-product supplier names are not reliably public.
-
How do I identify the actual Claritin-D manufacturing site from an NDC?
Use the NDC and match to FDA drug establishment/product listings plus lot traceability on the specific package.
-
Do Claritin-D manufacturers change by region or contract cycle?
Yes. OTC supply and manufacturing assignments can change by SKU, time period, and contract terms.
-
What documentation do procurement teams request to confirm Claritin-D supply chain?
CoAs, CoC/CoA linkage to lot, GMP manufacturing site confirmation, and FDA establishment mapping for the relevant NDC.
References
- U.S. Food and Drug Administration. (n.d.). Drug Establishments and drug product databases. https://www.fda.gov/drugs/drug-approvals-and-databases
