IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Perrigo R And D	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	H E B	37808-158-60	20 BLISTER PACK in 1 CARTON (37808-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2016-04-18
Perrigo R And D	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	United Natural Foods, Inc. dba UNFI	41163-158-60	20 BLISTER PACK in 1 CARTON (41163-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2015-07-17
Perrigo R And D	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	Meijer Distribution Inc	41250-158-60	20 BLISTER PACK in 1 CARTON (41250-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2014-09-17
Perrigo R And D	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	Kenvue Brands LLC	50580-436-01	2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2019-06-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

Ibuprofen and Phenylephrine Hydrochloride Drug Suppliers: Who Makes the API, Intermediates, and Finished Dosage Forms

Key supplier map for ibuprofen + phenylephrine HCl combination products hinges on three layers: (1) API manufacturers for ibuprofen and phenylephrine HCl, (2) contract manufacturers (CMOs) that build fixed-dose tablets/caplets, and (3) logistics and packaging supply chains (blister, bottle, cartons). The supplier set varies by geography and by whether the product is marketed as OTC cold/flu combination (oral solid dosage forms) versus prescription formulations.

Who supplies ibuprofen and phenylephrine hydrochloride APIs for combination cold products?

Featured-snippet answer: ibuprofen is widely sourced from multi-product chemical API manufacturers in China, India, and Europe; phenylephrine HCl APIs are also concentrated in Asia with additional sourcing from specialty chemical suppliers in the US/EU supply chain via distributors rather than direct API plants for OTC finished products.

Ibuprofen API supply pattern (global)

Large-scale ibuprofen API producers serve global OTC and generic markets due to high-volume demand and mature manufacturing routes.
Supply chains typically include:
- ibuprofen API plants
- intermediate suppliers for ester/acid conversion and chiral/oxidation steps (route-dependent)
- salt-form suppliers are generally not relevant because ibuprofen is already an acid (no salt switching in ibuprofen manufacture)

Typical procurement approach for finished-dose manufacturers

Finished-dose CMOs and brand/OTC packers buy ibuprofen API directly from accredited API vendors or via approved distribution partners.
Lot-by-lot CoA, impurity profiling (process impurities), and stability support drive vendor qualification.

Phenylephrine hydrochloride API supply pattern (global)

Phenylephrine HCl is manufactured and sold as the hydrochloride salt for formulation compatibility and stability.
Supply chains typically include:
- core phenylephrine synthesis suppliers
- HCl salt formation and crystallization steps (often part of the API manufacturer’s own process)
- optional downstream intermediate suppliers depending on whether the vendor is vertically integrated

Typical procurement approach for finished-dose manufacturers

API purchasers require impurity compliance suitable for OTC monographs and stricter generic specifications depending on the filing route used by the finished-dose manufacturer.

Which contract manufacturers (CMOs) make ibuprofen plus phenylephrine tablets or caplets?

Featured-snippet answer: most ibuprofen + phenylephrine HCl combination OTC products are made by oral solid CMOs that specialize in tablet/caplet compression, coating, and OTC packaging formats. These CMOs often act as fill-finish and packers for brand owners, private label, and generic firms.

CMO manufacturing scope that matters for this combination

Direct compression or granulation-based tablet/caplet production
Film-coating for taste masking and consumer acceptability
Blister and bottle packaging line capability (serialization optional depending on market)
Stability program execution (real-time and accelerated) with humidity/temperature controls

Common formulation-relevant manufacturing inputs

Excipient systems suitable for:
- ibuprofen dissolution performance
- phenylephrine HCl stability under humidity and light exposure
Lubricants and disintegrants validated against tablet hardness, friability, disintegration, and dissolution targets

What finished-dose suppliers distribute ibuprofen and phenylephrine hydrochloride in the US?

Featured-snippet answer: finished-dose supply in the US is dominated by established OTC and generic manufacturers that source APIs globally and then manufacture and distribute through US-controlled or US-supported packaging networks.

US distribution structure

Brand owner or OTC marketer contracts:
- API supply (direct or through distributor)
- formulation and packaging manufacturing
- US release testing and distribution
Private label programs often use the same CMO base across multiple brands, with specification differences handled through vendor quality agreements.

How do ibuprofen + phenylephrine hydrochloride supplier choices differ by geography?

Featured-snippet answer: Asia-based API production dominates both APIs, while US/EU finished-dose manufacture and release testing concentrates where regulatory QA and OTC distribution requirements are enforced.

Asia (API-heavy)

Higher availability and lower unit costs for ibuprofen API and phenylephrine HCl API
Longer lead times and heavier documentation requirements for change control and impurity updates

US/EU (finished-dose and release testing-heavy)

Finished dosage manufacturers, packers, and distributors emphasize:
- US QA release testing
- GMP compliance alignment
- adverse event traceability and batch genealogy

Which suppliers are likely to qualify under FDA GMP for OTC ibuprofen/phenylephrine products?

Featured-snippet answer: qualification is driven by FDA GMP and controlled supply chain documentation, not by supplier name. In practice, supply chain “qualification” is achieved by:

approved manufacturing site audits (internal or third-party)
validated analytical methods for API release and incoming inspection
change control systems for sourcing transitions

What buyers audit

API impurity profile against product specification
Nitrosamine and other contamination risk controls where relevant
Environmental controls for consistent crystallization and drying
Stability and packaging integrity data on the API and the intermediate/completed tablets

What API intermediates or upstream inputs affect supplier reliability for phenylephrine HCl?

Featured-snippet answer: phenylephrine HCl supply reliability is sensitive to upstream synthesis steps and crystallization capacity, because salt formation and drying are frequent pinch points in manufacturing capacity.

Upstream bottlenecks commonly seen in phenylephrine supply

Salt formation and crystallization equipment throughput
Drying and water-activity control for consistent polymorph or hydrate behavior
Overlap with other phenethylamine-derived intermediates used in multiple chemical programs

How do distributors factor into ibuprofen and phenylephrine hydrochloride sourcing?

Featured-snippet answer: for many finished-dose manufacturers, distributors serve as the procurement layer that consolidates API supply, manages vendor qualification status, and handles regulatory document flow (CoAs, GMP certificates, and traceability).

Distributor value-add

Approved vendor list management
Batch traceability support and deviation handling
Documentation continuity when API plants change or add production lines

What documentation and testing requirements typically apply to ibuprofen and phenylephrine hydrochloride suppliers?

Featured-snippet answer: incoming API testing and documentation requirements are driven by:

identity and purity specifications
impurity limits (process-related impurities)
stability data expectations for OTC products

Typical release/package documentation

Certificate of Analysis (CoA) with:
- identity (e.g., IR/DSC/HPLC method depending on vendor)
- assay and impurity panel
- residual solvents and water (as applicable)
GMP certificate and facility inspection history support
Batch manufacturing record attestation through quality agreements

What generic or private-label entry risks exist for ibuprofen/phenylephrine combo supply?

Featured-snippet answer: the main risk is not patent entry but supply continuity and QC compliance during vendor transitions. OTC combinations can change pack sizes and supplier lots frequently, increasing variability risk in impurity profiles and dissolution performance.

Practical risk factors

API vendor changeovers without adequate bridging data
Drying/crystallization process shifts that affect impurity pattern
Packaging supplier outages that delay blister/bottle availability

Key Takeaways

Ibuprofen + phenylephrine HCl combination products rely on a two-API supply model dominated by Asian API production and US/EU-oriented finished-dose manufacturing and release testing.
Finished-dose manufacturers commonly source APIs through qualified direct vendors or through distributors that manage documentation and compliance.
Supplier reliability depends on GMP compliance, impurity control, salt/crystallization process stability for phenylephrine HCl, and packaging throughput for blister/bottle formats.
Supply-chain risk is concentrated in upstream API process stability and downstream packaging capacity rather than in regulatory patent barriers.

FAQs

1) Who can manufacture ibuprofen and phenylephrine hydrochloride tablets under contract?

Oral solid CMOs with compression and coating lines plus OTC packaging capacity; selection is driven by GMP compliance, change control systems, and proven dissolution performance for ibuprofen with phenylephrine HCl stability.

2) Are ibuprofen and phenylephrine hydrochloride APIs interchangeable by supplier?

Not automatically. Even when both meet specs, supplier transitions can alter impurity profiles and dissolution behavior, requiring validated incoming controls and change control.

3) Does phenylephrine HCl require special handling compared with ibuprofen API?

Yes. Phenylephrine HCl involves salt/crystallization characteristics that make water content, polymorph/hydrate behavior, and drying controls more consequential.

4) How do packaging suppliers impact availability for this OTC combination?

Blister and bottle line downtime, labeling supply constraints, and carton material lead times can delay finished product release even if API supply is stable.

5) What drives pricing differences among API suppliers for these drugs?

Process complexity and yield, impurity control capability, certification and audit status, batch-to-batch consistency, and lead time plus documentation readiness.

References

FDA. Current Good Manufacturing Practice for Finished Pharmaceuticals. (21 CFR Parts 210 and 211). https://www.ecfr.gov/
FDA. Pharmaceutical Quality Policy and GMP/quality expectation documents. https://www.fda.gov/industry/quality
FDA. Guidance for Industry: ANDA Submissions—Content and Format for ANDA (as applicable to quality/CMC expectations). https://www.fda.gov/industry/abbreviated-new-drug-application

Suppliers and packagers for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE