CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441	NDA	Haleon US Holdings LLC	0573-0188-10	20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK	2002-12-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 26, 2026

What do “suppliers” mean for these APIs (and what categories matter for sourcing)?

Pharma supply chains typically split “suppliers” into four buckets. For chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride, business-relevant options are:

API manufacturers (produce the drug substance; usually hold relevant GMP certifications)
API traders/distributors (source from manufacturers; sell finished API batches)
Salt-form / intermediate specialty suppliers (only applicable when you buy the API as a specific salt or via defined intermediates)
CMOs for packaging and distribution (not API suppliers, but can control batch release logistics)

Without specifying dosage form, grade (USP/EP/BP), and regulatory target market, supplier lists are best built from publicly identifiable API manufacturer/distributor portfolios. Under that constraint, the only complete, defensible response possible is to provide named suppliers that have public, recurring roles in the API market for these APIs.

Which suppliers commonly supply chlorpheniramine maleate (API)?

Chlorpheniramine maleate is widely manufactured because it is a legacy antihistamine and appears in many OTC and prescription formulations.

Common API supply sources include large generic API and intermediate groups:

Lupin (API manufacturing and generics supply chain)
Aurobindo Pharma (API manufacturing footprint)
Cipla (API manufacturing and supply)
Sun Pharmaceutical Industries (API and generics supply)
Teva API (API supply via Teva’s network)
Zydus Lifesciences (API manufacturing)
Torrent Pharmaceuticals (API manufacturing)
Mylan (Viatris) (API supply via corporate network)
Hikma (API manufacturing and supply network)

Specialty/parallel sourcing routes (traders/distributors):

McKesson and Cardinal Health (pharma distribution; often route OTC and chemical grades via authorized channels)
AmerisourceBergen (Cencora) (API and chemical distribution via authorized supply)
Brenntag and Univar Solutions (chemical distribution; may support secondary sourcing depending on regulatory classification)

Which suppliers commonly supply ibuprofen (API)?

Ibuprofen is high-volume and has a broad supplier base. The API supply market is dominated by large generic API producers and chemical synthesis specialists.

Common API supply sources include:

BASF (chemical production scale for NSAID supply chain routes)
Evonik (chemical supply chain capability; ibuprofen supply presence depends on market segment)
Boehringer Ingelheim (legacy and generic supply via network; varies by region)
Teva API (API manufacturing and supply)
Aurobindo Pharma
Sun Pharma
Sandoz (Novartis) (generic and API supply chain)
Lupin
Cipla
Mylan (Viatris)
Hikma

Secondary sourcing and distribution:

Cencora (AmerisourceBergen)
McKesson
Cardinal Health
Brenntag
Univar Solutions

Which suppliers commonly supply pseudoephedrine hydrochloride (API)?

Pseudoephedrine hydrochloride is controlled in many jurisdictions because it is a precursor used in illicit drug manufacture. This typically narrows the number of acceptable API suppliers and requires stronger compliance documentation (customer screening, end-use statements, and shipment tracing).

Common API supply sources include:

Jiangsu Hengrui (API network in China) (presence in many pharma intermediate and API supply chains)
Xian Janssen / Janssen network (via corporate and authorized sourcing channels, depending on market)
Teva API (where legally available)
Mylan (Viatris) (where legally available)
Lupin (where legally available)
Aurobindo Pharma (where legally available)

Specialist distributors and compliance-heavy channels (availability depends on jurisdiction):

Cencora (AmerisourceBergen)
McKesson
Cardinal Health
Authorized chemical API distributors that maintain controlled-substance/precursor compliance programs

How should you structure a sourcing list to be operational (manufacturer vs trader)?

Because these APIs have very different regulatory and supply-chain constraints, the practical sourcing approach is:

Chlorpheniramine maleate and ibuprofen

Prioritize API manufacturers (multiple GMP suppliers exist)
Add authorized distributors as backup for capacity, lead time, and batch scheduling

Pseudoephedrine hydrochloride

Prioritize licensed/qualified API manufacturers with a record of controlled precursor compliance
Use only authorized distributors with traceability and screening controls

What evidence to request in supplier qualification (minimum set that maps to these APIs)?

To keep qualification tight and auditable, request documentation that directly ties to batch release and regulatory compliance:

GMP certificate (API facility)
DMF status or equivalent dossier access (where applicable)
CoA for representative batches
Impurity profile and specification (including solvent and residuals, and for the salt form: specific salt and counterion controls)
Stability protocol and shelf-life basis
For pseudoephedrine HCl: controlled precursor compliance program documentation (end-use and end-user controls; shipping traceability)

Supplier shortlists (action-ready)

Below is a practical shortlist by API using the supplier categories above. This is designed to seed outreach for procurement and regulatory assessment.

API	Primary supplier category to contact first	Supplier names to start with
Chlorpheniramine maleate	API manufacturers	Lupin; Aurobindo Pharma; Cipla; Sun Pharma; Teva API; Zydus; Torrent; Viatris; Hikma
Ibuprofen	API manufacturers and chemical-scale producers	BASF; Teva API; Aurobindo Pharma; Sun Pharma; Sandoz; Lupin; Cipla; Viatris; Hikma
Pseudoephedrine hydrochloride	Qualified controlled-precursor API manufacturers (plus licensed distributors)	Teva API; Viatris; Lupin; Aurobindo Pharma; Jiangsu Hengrui network (where legally supplied)
All three (backup)	Authorized distributors	Cencora; McKesson; Cardinal Health; Brenntag; Univar Solutions

Key Takeaways

Chlorpheniramine maleate and ibuprofen have broad API supplier depth, making API-manufacturer sourcing and distributor backup both viable.
Pseudoephedrine hydrochloride is constrained by controlled-precursor rules; qualifying suppliers requires compliance-forward screening and controlled shipment traceability.
Build sourcing lists in two tiers: API manufacturer (primary) and authorized distributor (backup), then qualify using GMP, CoA, specs, and for pseudoephedrine, precursor controls.

FAQs

Can I source pseudoephedrine hydrochloride through general chemical distributors?
Only through authorized channels that run controlled-precursor compliance and traceability programs.
Do chlorpheniramine maleate and ibuprofen require salt/form-specific sourcing?
Chlorpheniramine must match the maleate salt form; ibuprofen is typically sourced as the free acid, but grade and spec matter.
What is the quickest path to qualified supply for ibuprofen?
Start with major generic API manufacturers, then add distributor backups for batch scheduling.
Which documentation most directly supports regulatory readiness?
GMP certificate, CoA, and the impurity/specification set aligned to your target market requirements.
Why does supplier availability differ for pseudoephedrine versus ibuprofen?
Pseudoephedrine is regulated as a controlled precursor in many jurisdictions, narrowing eligible supply and increasing compliance steps.

References

[1] Bloomberg Terminal / company profiles for Lupin, Aurobindo Pharma, Cipla, Sun Pharmaceutical Industries, Teva, Zydus, Torrent, Viatris, Hikma, Sandoz (access-dependent).
[2] Public corporate information for Cencora, McKesson, Cardinal Health, Brenntag, Univar Solutions (authorized distribution activities; access-dependent).
[3] Regulatory overview materials on controlled precursor frameworks for pseudoephedrine hydrochloride (jurisdiction-dependent; access-dependent).

Suppliers and packagers for generic pharmaceutical drug: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE