BENZOYL PEROXIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510	NDA	Galderma Laboratories, L.P.	0299-5890-00	3 g in 1 BOTTLE, PUMP (0299-5890-00)	2022-05-09
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510	NDA	Galderma Laboratories, L.P.	0299-5890-30	1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP	2022-05-09
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510	NDA	Mayne Pharma Commercial LLC	51862-772-30	1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP	2025-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 24, 2026

Who supplies benzoyl peroxide for pharmaceutical use (API and excipient-grade)?

Benzoyl peroxide (BPO) is commercially sourced from a concentrated set of commodity chemical producers that sell either:

BPO (manufactured chemical) used as an API or intermediate depending on grade and dossier strategy
BPO formulations (finished topical drug products) through branded and generic manufacturers, where BPO quantity is compounded under regulated manufacturing controls

In practice, “pharmaceutical supply” for BPO typically breaks down into two channels:

Specialty chemical manufacturers selling BPO under controlled specifications (purity, particle size, assay, residuals), often with compliance packages for regulatory submissions.
Topical drug product manufacturers (finished dosage forms) that buy BPO and build the product under GMP, while the BPO supplier role sits upstream.

Because “benzoyl peroxide suppliers” depends on whether you want bulk chemical (API-grade / excipient-grade) or finished pharmaceutical product, supplier lists change materially.

Which companies are the core global suppliers of benzoyl peroxide?

The global BPO supply base is dominated by chemical producers with multi-ton, multi-application manufacturing. The suppliers below are the most consistently referenced in commercial supply for BPO (including industrial and pharma-relevant grades) based on their market presence and role as BPO producers.

Global benzoyl peroxide chemical suppliers (upstream BPO)

Evonik (Germany) (BPO and related peroxide chemistries across specialty applications)
Arkema (France) (peroxides business; BPO is part of the broader peroxide portfolio)
Nippon Shokubai (Japan) (peroxide supply capability through established chemistry platforms)
Lucite/Manufacturers within specialty chemical ecosystems (where BPO is produced and distributed through regional specialty channels)

Regional distributors and compliance-focused resellers

BPO is also sold by compliance-focused distributors who handle documentation, shipping controls for energetic materials, and grade sorting (common in pharma procurement). These include:

Pharmaceutical/chemical distributors supplying BPO under customer-specific CoA and specs
Chemical traders supplying different grades (industrial vs pharma-relevant), often with batch documentation

Procurement note: pharma-grade supply is usually distinguished by batch documentation, residual solvent/residual catalyst controls, assay specification, and particle size distribution, not by the trademark name alone.

Which suppliers are used for finished benzoyl peroxide drug products?

When the requirement is a “benzoyl peroxide product supplier” (finished topical medicines), the supplier set becomes generic and branded pharmaceutical companies that manufacture creams, gels, and washes containing BPO.

Finished dosage suppliers typically include:

Generic topical dermatology manufacturers with BPO strengths (common strengths include 2.5%, 5%, and 10% depending on jurisdiction)
Branded acne products manufacturers in their target markets

In this route, the upstream BPO supplier matters less to the end customer than the GMP manufacturing site and regulatory documentation for the specific drug product.

What procurement specs determine whether a benzoyl peroxide supplier is “pharma-ready”?

BPO suppliers vary widely on what they can document for a regulated application. Pharmaceutical procurement typically requires evidence on the following:

Chemical and quality

Assay (active content)
Impurities (including oxidative byproducts)
Residual solvents
Water content
Particle size and polymorphic form (critical for topical performance and uniformity)

Material handling and controls

Temperature and shipping controls suitable for peroxide stability
Batch traceability and change control history

Regulatory documentation

CoA per batch
Controlled specification sheets (and often a dossier-ready technical package)
Quality system alignment with GMP/ISO requirements

How does benzoyl peroxide supplier selection differ by grade: API vs excipient?

BPO is used across regulated contexts as either:

Active ingredient (API) in topical products
Component/excipient-like role in certain formulations depending on jurisdiction and product strategy

Supplier choice shifts based on:

whether you need a pharma dossier-compatible material set
whether you can accept an excipient-quality specification
whether the application drives particle size requirements (often the deciding factor for performance)

What are the main sourcing risks with benzoyl peroxide?

Even for well-established suppliers, procurement risk is shaped by the energetic-material nature of peroxides:

Stability and shelf-life management (temperature excursions and storage conditions)
Batch-to-batch variability in particle size and impurities
Regulatory and shipping constraints for peroxides
Contracting and supply continuity driven by production scheduling in the peroxide market

These risks drive why pharma customers prefer suppliers who can provide consistent documentation and reliable batch release processes, not only low price.

Key Takeaways

Benzoyl peroxide supply is dominated by upstream chemical producers plus regional distributors, with the “pharma supplier” label usually depending on documentation, specs, and batch traceability, not brand identity alone.
For pharma use, the real decision points are assay/impurities, particle size, residuals, shipping stability controls, and regulatory-grade documentation.
If you need finished topical products, the supplier set becomes finished-dose GMP manufacturers, with upstream BPO procurement less visible.

FAQs

1) Is benzoyl peroxide usually sourced as an API or as an excipient?

It is commonly sourced as the active ingredient for topical dermatology products, but the classification can vary by regulatory strategy and local dossier structure.

2) Do suppliers differ by particle size for benzoyl peroxide?

Yes. Particle size distribution materially affects topical performance and uniformity, and many pharma-grade specifications include targeted ranges.

3) What documentation matters most when buying benzoyl peroxide for regulated products?

Per-batch CoA, controlled specification sheets, traceability, and documentation covering impurities/residuals and stability handling.

4) Are benzoyl peroxide suppliers the same for finished products and bulk chemical?

No. Finished product manufacturers are responsible for GMP manufacturing. Bulk suppliers provide the chemical upstream with quality systems and specs.

5) What supply constraints affect benzoyl peroxide procurement?

Peroxide handling constraints (storage and transport), batch stability, and market production schedules in the peroxide category.

References

[1] PubChem. Benzoyl peroxide. National Center for Biotechnology Information. https://pubchem.ncbi.nlm.nih.gov/compound/Benzoyl-peroxide
[2] European Medicines Agency (EMA). Benzoyl peroxide related product information and assessment context (search portal). https://www.ema.europa.eu/
[3] U.S. FDA. Dermatology drug product information and ingredient context (search portal). https://www.fda.gov/drugs

Suppliers and packagers for generic pharmaceutical drug: BENZOYL PEROXIDE