Last updated: April 24, 2026
Who Supplies Clarinex (Desloratadine) and What to Verify in Source Chains?
Clarinex is the brand name for desloratadine, an oral antihistamine. The active pharmaceutical ingredient (API) and finished-dose product can come from multiple supply chains depending on market, dosage form, and contract manufacturing arrangements.
Which companies supply desloratadine (API) for Clarinex-type products?
A complete, market-level supplier roster requires inspection of (1) the dossier for the specific registered product in a given country and (2) current manufacturer-of-record data from regulatory listings. Without those product-specific filings and current listings, there is not enough verifiable information to name specific API suppliers for “Clarinex” in a way that stands up to diligence.
Which companies manufacture finished-dose Clarinex tablets/syrup?
Same constraint: finished-dose “manufacturer of record” changes by country and by product lifecycle stage (launch, line changes, contract manufacturing shifts). Naming specific finished-dose manufacturers without binding, current regulatory or labeling evidence risks listing entities that do not supply the relevant registered product at the time of use.
What supplier identifiers should be used to verify claims in diligence?
Use these fields when pulling supply-chain evidence from regulatory/label documents and commercial quality agreements:
| Verification target |
What to look for |
Why it matters |
| API manufacturer(s) |
“Manufactured by” and “Active substance” sections in the product monograph/CTD Module 3 |
Confirms the actual API source for the registered product |
| Finished dosage manufacturer |
“Manufactured by” / “Product released by” / “Marketing authorization holder” chain |
Distinguishes manufacturing vs. marketing ownership |
| Site addresses |
Manufacturing site addresses tied to license numbers |
Prevents “group company” substitutions |
| GMP compliance evidence |
Inspection outcomes and compliance status per site |
Supports quality risk scoring |
| Batch release references |
Testing and release site in batch records |
Confirms operational release chain |
What do you need to lock down for investment-grade supplier mapping?
Supplier mapping for desloratadine-based brands should be built from traceable, product-specific evidence:
- Country and strength/dosage form (tablets vs oral solution)
- Marketing authorization holder in that country (brand ownership differs by jurisdiction)
- API manufacturer-of-record in the approved label or dossier
- Finished product manufacturer-of-record in the approved label or dossier
- Changes over time (line transfers, site substitutions, post-approval variations)
What is the practical supplier landscape for desloratadine, structurally?
For most global antihistamine brands, supplier structure typically splits into:
- API production sites that supply multiple finished-dose manufacturers
- Finished-dose manufacturers under contract with the marketing authorization holder
- Local packaging and labeling sites that vary by country
The exact company list for “Clarinex” depends on which registered product you mean.
Key Takeaways
- “Clarinex” is desloratadine, but the supplier list is product- and country-specific and can change over time.
- Diligence-grade “suppliers for Clarinex” must be supported by regulatory label/dossier manufacturer-of-record fields for the specific dosage form and market.
- Without those specific, current regulatory product references, naming specific API or finished-dose suppliers is not reliable.
FAQs
1) Is Clarinex’s active ingredient desloratadine?
Yes. Clarinex is branded desloratadine.
2) Are Clarinex suppliers the same worldwide?
No. API and finished-dose manufacturer-of-records can differ by country and can change with manufacturing transfers.
3) Where can supplier names be confirmed for due diligence?
In the country-specific approved product label and the regulatory dossier (CTD Module 3) that lists API and finished dosage manufacturers.
4) Why do supplier lists change for branded products?
Manufacturing site transfers, contract manufacturing switches, and post-approval variations commonly change manufacturer-of-record.
5) What supplier data is most important for quality and risk?
Site addresses tied to GMP status, API manufacturer-of-record, and finished product manufacturer-of-record, not just corporate group names.
References
[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (desloratadine and branded products entries). https://www.accessdata.fda.gov/scripts/cder/ob/
[2] EMA. European public assessment reports (EPAR) and product information for desloratadine-containing products. https://www.ema.europa.eu/
[3] WHO. International Nonproprietary Names (INN) for pharmaceutical substances (desloratadine monograph context). https://www.who.int/teams/regulation-prequalification/inn
