IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565	NDA	Haleon US Holdings LLC	0573-0199-01	50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH	2015-07-01
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565	NDA	Haleon US Holdings LLC	0573-0199-03	3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH	2015-07-01
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565	NDA	Haleon US Holdings LLC	0573-0199-11	10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK	2015-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Executive summary: Supplier coverage for ibuprofen and phenylephrine hydrochloride (PEHCl) is broad at the API level, with China and India dominating primary synthesis. Competitive bottlenecks shift from raw API supply to regulatory-grade quality systems (DMFs/CEP), impurity control, and downstream formulation availability for common dosage forms (tablets, capsules, and combination cold-and-flu products). For procurement and IP-risk screening, the key workstreams are: (1) confirm DMF/CEP holders and which suppliers have approved commercial manufacturing history, (2) map which suppliers can reliably meet impurity specifications tied to each DMF, and (3) separate API supply from excipient and packaging vendors that constrain change control.

Which companies supply ibuprofen APIs and what grades are available?

Most ibuprofen supply chains converge on bulk chemical manufacturing with downstream crystallization and particle-size control for tablet/capsule grades. Procurement should be mapped by regulatory documentation (DMF/CEP) and by whether the supplier is integrated into downstream solid oral manufacturing or only sells API.

Ibuprofen API supplier profile (typical market structure)

API-only manufacturers: produce and sell ibuprofen in bulk; customers qualify via DMF and stability/impurity data.
API with intermediates: often offers stronger impurity control and traceability on key process impurities.
Contract manufacturers (CMOs): offer finished dose manufacturing and sometimes “bridge” regulatory packages if the buyer files a new process under an existing supplier’s DMF pathway.

Common procurement checkpoints for ibuprofen

Regulatory status: DMF availability for US FDA and/or CEP routes used in other jurisdictions.
Specification match: USP/EP alignment and tight controls on key impurities (process-related and stereochemical impurities).
Particle engineering: suitability for direct compression (if needed) and consistent dissolution performance.
Supply continuity: site-level uptime, batch size capability, and ability to meet annual forecast swings.

Typical API and salt form

Ibuprofen is supplied as the active ingredient in neutral form for solid oral products; no salt conversion is typical for standard OTC analgesics.

Who supplies phenylephrine hydrochloride (PEHCl) APIs and what makes the supply chain constrained?

PEHCl API is widely available, but supplier qualification is tighter in practice because PEHCl is heavily used in combination cold-and-flu products and monographs, which drives stricter impurity and assay specs and frequent change-control scrutiny.

PEHCl API supplier profile (typical market structure)

API manufacturers: produce PEHCl bulk chemical; deliver CoA with batch-specific impurity panels.
Specialty chemical producers: supply intermediates that reduce variability if the buyer needs controlled sourcing.
Downstream combo manufacturers: control the “system” (API + excipients + blending + compression) which can be operationally easier than switching API-only suppliers.

Procurement checkpoints for PEHCl

DMF/CEP coverage for the intended market.
Impurity control: limits for related substances that differ by pharmacopeia and by regulatory submission.
Moisture and particle properties: affects compression performance and stability in combination tablets.
Manufacturing traceability: documentation discipline matters due to OTC market scrutiny and frequent product refresh cycles.

Typical API and salt form

Phenylephrine hydrochloride is supplied as the hydrochloride salt for most oral dosage forms.

Which API suppliers cover both ibuprofen and PEHCl, and how does overlap matter?

Cross-supplier overlap is commercially relevant for combination products because it can shorten procurement lead times and reduce qualification cycles. Practically, even when one supplier sells both APIs, the buyer still must qualify each DMF and ensure impurity panels and polymorph/crystal forms are consistent across drug product lots.

Overlap procurement implications

Qualification load: one supplier may reduce vendor onboarding friction but does not remove the need for finished product bridging.
Change control: switching either API site or intermediate supplier can trigger additional validation, especially in multi-ingredient tablets.
Supply resilience: overlap can help if one API market tightens, but shared geography can also increase correlated risk.

What excipients and processing aids do ibuprofen and PEHCl products require, and who supplies them?

Even when the buyer’s focus is APIs, the operational “supplier set” for solid oral dosage forms often becomes the limiting factor: glidants, binders, lubricants, disintegrants, coating polymers, and film coating systems.

Excipients commonly used in ibuprofen tablets/capsules

Binders (e.g., PVP-based systems, cellulose derivatives)
Disintegrants (e.g., croscarmellose sodium)
Lubricants/glidants (e.g., magnesium stearate, silica)
Coating polymers (HPMC-based or cellulose acetate-based systems)
Colorants and opacifiers for OTC branding

Excipients commonly used in PEHCl-containing combination products

Same solid oral toolkit as ibuprofen, with attention to:
- stability interactions (API/API and API/excipient)
- compression and flow needs for PEHCl blends
- film coat permeability if products include moisture-sensitive components

Processing aids and manufacturing inputs

Granulation systems (dry vs wet granulation choices influence excipient selection)
Purified water and solvents (affects validation scope)
Packaging materials: blister foil, HDPE bottles with desiccant/closure systems

What dosage forms dominate market demand for ibuprofen and PEHCl inputs?

Procurement strategy differs by dosage form because it changes validation scope, blending and compression requirements, and packaging constraints.

Ibuprofen common dosage forms

Immediate-release tablets and capsules
Liquid formulations (less common for API sourcing focus, more complex for excipient/system)
Extended-release variants (tight control on matrix systems, often tied to specific formulation platforms)

PEHCl common dosage forms

Immediate-release tablets/capsules in cold-and-flu combination products
Liquids less frequently for standard market SKUs depending on region
Multi-API combinations with analgesics and antihistamines

How do DMF or CEP listings affect which suppliers can be used for regulatory filings?

For buyers targeting US and regulated global markets, the gating item is whether the supplier’s dossier is usable for the intended regulatory pathway.

US FDA pathway dynamics

DMF holders: procurement can rely on DMF cross-reference only if properly authorized and aligned with the buyer’s submission strategy.
Site and process matching: the buyer must ensure the incoming API matches the DMF-described manufacturing route and impurity profile.

EU/UK pathway dynamics

CEP-based qualification: can be faster for certain market submissions, but still requires finished dose validation and compliance with local requirements.

Which supplier qualification risks matter most for ibuprofen and PEHCl (impurity, polymorph, batch variability)?

The highest-probability failures in API qualification are not “availability” but “fit-for-filing” and “fit-for-manufacturing.”

Ibuprofen-specific risk points

Impurity profile drift due to process changes
Crystal form and particle size variability impacting dissolution and tablet compression
Batch-to-batch CoA variability that forces incoming batch testing

PEHCl-specific risk points

Impurity drift and related substances limits tied to each regulatory submission
Moisture uptake and blending performance variability in combination tablets
Supply chain documentation gaps that complicate audits

Cross-cutting risks

Unapproved change history for intermediate synthesis
Incomplete analytical method transfer packages
Lack of robust stability data supporting shelf-life claims

Which manufacturers make combination cold-and-flu products that drive PEHCl demand, and how does that affect API sourcing?

PEHCl is often sold into fixed-dose combinations, which concentrates purchasing and drives supplier onboarding around high-volume commercial supply.

Commercial implications

Multi-ingredient product manufacturers frequently use preferred API suppliers to reduce change control.
When a primary supplier tightens allocation, manufacturers switch based on dossier compatibility and short bridging timelines.

How many qualified suppliers typically exist for ibuprofen and PEHCl, and what does that mean for negotiation?

Supplier count varies by regulatory grade availability and dossier coverage. Negotiation leverage usually depends on:

number of suppliers with active DMFs/CEPs compatible with the buyer’s markets
ability to supply consistent impurity panels at scale
readiness for tech transfer and analytical method alignment

Procurement leverage pattern

If multiple DMF/CEP holders meet specs, buyers can negotiate on price and lead time.
If only a subset meets dossier and impurity controls, buyers shift negotiation to qualification speed, long-term supply agreements, and audit cadence rather than unit price.

What contract manufacturing and scale-up constraints limit switching suppliers for ibuprofen and PEHCl?

Switching API suppliers is rarely “drop-in.” It triggers:

incoming testing
blending and compression process verification
stability re-runs depending on change classification

Key constraints

Tight dissolution specs (ibuprofen)
Blending performance and uniformity (PEHCl combinations)
Compatibility with existing film coating formulation and packaging moisture barriers

What does the supplier landscape look like by geography (China, India, Europe, US)?

The practical reality is that China and India dominate API production capacity for both ibuprofen and PEHCl, with Europe and the US more often acting as:

finished dose manufacturing hubs
formulation/excipient and packaging ecosystems
secondary API sourcing through qualified importers

Geography matters for procurement

lead times and freight terms
audit schedules and quality system maturity
batch analytics availability and method robustness

Key takeaways

Ibuprofen and PEHCl have wide nominal API supplier coverage, but regulatory usability and impurity control determine which suppliers are actually selectable.
Procurement risk is concentrated in dossier alignment (DMF/CEP), site/process equivalence, and impurity stability, not in basic availability.
For combination products, excipient and packaging suppliers can become the limiting qualification bottleneck even after API approval.
Negotiation leverage increases when multiple suppliers offer dossier-compatible API with stable impurity panels at scale.

FAQs

1) What documents should be required from ibuprofen and PEHCl API suppliers to support regulatory filings?
CoA with impurity panel; DMF/CEP linkage documentation; full batch analytical reports; stability data; change history; validation and method transfer packages for QC testing.

2) Which quality attributes most often trigger rejection when qualifying ibuprofen API?
Impurities outside spec, dissolution-impacting particle size variation, and batch variability that fails incoming test specifications.

3) Which quality attributes most often trigger rejection when qualifying PEHCl API?
Assay drift and out-of-limit related substances, blending/moisture related performance issues in combination tablet formulations.

4) How do you reduce change-control burden when switching ibuprofen or PEHCl suppliers?
Use dossier-compatible suppliers and require demonstrable site/process equivalence, then run incoming testing and targeted process verification rather than full revalidation where justified.

5) Does using the same supplier for ibuprofen and PEHCl reduce qualification risk for combination products?
It can reduce vendor onboarding friction, but regulatory and formulation qualification risks persist because impurity profiles and process specifics still must match.

References

No sources were provided in the prompt, and no compliant, named supplier dataset with citable identifiers (DMF holder lists, CEP databases, or official regulatory listings) was included in the input.

Suppliers and packagers for generic pharmaceutical drug: IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE