desloratadine; pseudoephedrine sulfate: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313	NDA	Organon LLC	78206-120-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)	2021-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 3, 2026

Desloratadine and Pseudoephedrine Sulfate Suppliers: API and Finished-Dose Sourcing Map

Desloratadine and pseudoephedrine sulfate are sourced through two distinct supply chains: (1) controlled-activity frameworks for pseudoephedrine (regulated precursor), and (2) standard API and formulation sourcing for desloratadine. Below is the supplier map used in commercial due diligence for API procurement, CMOs, and finished-dose manufacturing for products containing these actives (most commonly allergy/upper-respiratory combinations).

Who supplies desloratadine API and finished-dose products?

Short answer: Desloratadine is supplied by global generic API manufacturers and specialty intermediates players, with additional capacity from contract manufacturers producing tablets and orally disintegrating tablets (ODTs) under sourcing and licensing arrangements.

Common supplier categories

Desloratadine API manufacturers: firms producing the API for global generic and branded tablet makers.
Intermediate makers: businesses supplying desloratadine key intermediates for contract synthesis and route optimization.
Finished-dose CMO/packers: companies producing tablets/ODTs and secondary packaging for brands and generics.

Typical product dosage forms to ask about

Tablets (immediate release)
ODTs (where supported by local registration)
Combination products (varies by country; pseudoephedrine combinations are more region-specific)

Who supplies pseudoephedrine sulfate API for pharma use?

Short answer: Pseudoephedrine sulfate is supplied by fewer qualified producers because it is a regulated precursor under national and cross-border controls. Supply is concentrated among established chemical and pharmaceutical-precursor distributors and API manufacturers with compliance infrastructure.

How pseudoephedrine supply chains differ

Regulatory gating: procurement requires verified end use, licensing, and reporting.
Distribution controls: shipments are monitored end-to-end (import, transit, and domestic storage).
Channel concentration: fewer approved suppliers; larger lead times; higher audit and documentation burden.

Typical compliance documents required by suppliers

Licensed importer/manufacturer credentials
End-use statements and permitted manufacturing purpose
Audit packages for storage, inventory controls, and diversion prevention

Which suppliers are used for regulated-precursor logistics of pseudoephedrine sulfate?

Short answer: In practice, pseudoephedrine sulfate sourcing relies on (1) API manufacturers that hold the required precursor permissions and (2) GMP chemical distributors with regulated supply-chain programs.

Supplier qualification checkpoints

Precursor registration status in key jurisdictions
GMP certification and batch traceability systems
Documented ability to support regulatory filings (DMFs, ASMFs where used)
Audit history for diversion control, inventory reconciliation, and shipping controls

What API manufacturers make desloratadine and pseudoephedrine sulfate, and do they share capacity?

Short answer: Most firms do not vertically integrate across both actives at scale. Desloratadine API supply is broader; pseudoephedrine sulfate tends to be concentrated in precursor-permission-compliant networks. Many buyers source each active from different manufacturers and then validate finished-dose manufacturing through a CMO.

Commercial implication

Dual-active sourcing commonly becomes a project-management issue:
- API qualification and incoming testing for both actives
- Harmonizing impurity specs and stability requirements
- Aligning retest periods, batch release timing, and packaging lead times

What CMOs produce tablets or ODTs containing desloratadine with pseudoephedrine sulfate?

Short answer: CMOs generally manufacture combination products only where they have:

proven process capability for the specific blend (dose, excipient system),
documentation readiness for regulatory dossiers, and
supplier-approved incoming API qualification packages for both actives.

Process development areas that affect supplier selection

Wet granulation vs direct compression feasibility
Compatibility of API particle properties with excipients
Stability under moisture and temperature conditions for ODTs and fast-disintegrating tablets
Cleaning validation when producing multiple allergy indications

How do supplier lead times and batch release differ between desloratadine and pseudoephedrine sulfate?

Short answer: Lead time and batch release timelines generally diverge because pseudoephedrine is constrained by precursor controls and import/export scheduling, while desloratadine typically follows standard API release cycles.

Operational effects

Pseudoephedrine sulfate procurement often drives overall project critical path
Desloratadine can usually be sourced more flexibly, but must match:
- impurity profiles
- retest periods
- intended registration strategy for the finished-dose dossier

Which document packages matter most when buying desloratadine and pseudoephedrine sulfate APIs?

Short answer: Buyers prioritize a dossier-style compliance package: DMF/ASMF support where applicable, GMP evidence, COA reliability, and validated impurity specifications.

Buyer-facing documentation checklist

Certificate of Analysis (COA) with validated impurity methods
GMP certificate for the API manufacturing site
Regulatory starting material and synthesis route documentation for DMF/ASMF readiness
Stability program commitments aligned to labeling shelf life
Shipping and chain-of-custody records (especially for pseudoephedrine sulfate)

What Orange Book or regulatory listing signals supplier readiness for these drugs?

Short answer: For U.S. generic market entry strategies, regulatory listing readiness typically correlates with whether ANDA applicants have credible API sourcing and demonstrated bioequivalence. However, the actives themselves are not “supplier brands”; supplier readiness is evidenced via filings and ANDA dossiers.

How to use regulatory signals in supplier selection

Validate whether ANDA/brand combinations list specific manufacturing sites
Confirm whether there is a stable CMC history for similar strengths and dosage forms
Check whether multiple applicants reference the same (or comparable) API impurity controls

What generic entry risks exist for combination products involving desloratadine and pseudoephedrine sulfate?

Short answer: Risk comes from CMC and regulatory defensibility, not supplier availability alone.

Risk drivers

Combination product formulation stability and dissolution
Strength-specific impurity control and impurity matching across suppliers
Consistency of bioequivalence bridging across dose strengths
Regulatory constraints on pseudoephedrine procurement logistics for manufacturing timelines

Which jurisdictions drive supplier compliance for pseudoephedrine sulfate?

Short answer: Supplier compliance is strongest in jurisdictions with strict precursor tracking and defined reporting requirements for importation, possession, and distribution.

Jurisdictional enforcement themes

Import permit issuance and reporting
End-use verification
Inventory reconciliation requirements
Additional controls for diversion-risk scenarios

Key takeaways

Desloratadine supply is comparatively broader across API makers and CMOs for tablet and ODT formats.
Pseudoephedrine sulfate supply is highly constrained by regulated-precursor frameworks, concentrating qualified manufacturers and compliance-ready distributors.
Dual-active finished-dose supply chains usually require two different upstream API sourcing lanes, then integration via a CMO with proven process capability and regulatory-ready CMC.
Lead time and batch release are typically driven by pseudoephedrine sulfate procurement and precursor logistics, making it the critical path item for commercial planning.
Supplier selection should be dossier-driven: GMP, COA/impurity controls, stability alignment, and chain-of-custody documentation for pseudoephedrine sulfate.

FAQs

1) What does a compliant pseudoephedrine sulfate supplier typically provide beyond a COA?

A supplier typically provides precursor-permission evidence, chain-of-custody documentation, end-use support, and batch-level traceability sufficient for audit.

2) Can a buyer qualify a new desloratadine API supplier quickly for an existing finished-dose product?

Often it is feasible but still requires bridging work: impurity profile alignment, stability confirmation, and change-control documentation for CMC and regulatory filings.

3) Are ODT formulations more sensitive to supplier-to-supplier variability for desloratadine?

Yes. ODT performance is sensitive to particle properties and excipient compatibility, so switching API supplier may require additional dissolution and stability verification.

4) What typically slows down pseudoephedrine sulfate manufacturing start dates?

Import/export scheduling, permit timelines, inventory reconciliation requirements, and controlled distribution logistics.

5) Do pseudoephedrine sulfate suppliers provide intermediate rather than finished API?

Some networks supply intermediates under GMP and controlled permissions; finished API qualification and regulatory acceptance depend on dossier strategy and impurity specs.

References

No sources were provided in the prompt, and no external source set is available in this context.

Suppliers and packagers for generic pharmaceutical drug: desloratadine; pseudoephedrine sulfate