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Suppliers and packagers for ERYTHROMYCIN AND BENZOYL PEROXIDE
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ERYTHROMYCIN AND BENZOYL PEROXIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rising | ERYTHROMYCIN AND BENZOYL PEROXIDE | benzoyl peroxide; erythromycin | GEL;TOPICAL | 065385 | ANDA | Rising Pharma Holdings, Inc. | 64980-328-01 | 23.3 g in 1 JAR (64980-328-01) | 2016-10-18 |
| Rising | ERYTHROMYCIN AND BENZOYL PEROXIDE | benzoyl peroxide; erythromycin | GEL;TOPICAL | 065385 | ANDA | Rising Pharma Holdings, Inc. | 64980-328-02 | 46.6 g in 1 JAR (64980-328-02) | 2016-10-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ERYTHROMYCIN AND BENZOYL PEROXIDE
Who Supplies Erythromycin and Benzoyl Peroxide for Pharmaceutical Use?
Erythromycin and benzoyl peroxide are widely sourced building blocks in drug product manufacturing (notably topical acne combinations). Supply is typically split between (1) API and (2) key excipient-grade/chemical-grade inputs used to formulate finished products.
What suppliers are used for eryTHROMYCIN (API)?
Erythromycin API is sourced from global API manufacturers, contract API producers, and intermediates-to-API platforms. Common supply channels include:
| Supplier / Group type | What they typically supply | Notes for sourcing diligence |
|---|---|---|
| Major China-based API manufacturers | Erythromycin API in bulk | Often supply via distributors to EU/US; strong focus on cost and scale |
| Indian API manufacturers | Erythromycin API | Frequently integrated with multiple antibiotic lines; strong documentation practices for regulated markets |
| European/pharma-grade antibiotic producers | Erythromycin API (less common vs Asia) | More likely to support EU/EEA tendering and local quality systems |
| Global specialty chemical distributors | API and alternative sourcing | Useful when qualifying backups; requires audit trail and CoA discipline |
Sourcing reality for business: the practical market for erythromycin API is dominated by a handful of large-volume manufacturers outside the US/EU, with distributors acting as the interface to finished dose manufacturers.
What suppliers are used for benzoyl peroxide (BPO)?
Benzoyl peroxide is a bulk oxidant used in acne products (often with excipient systems and controlled particle properties). Supply often includes:
| Supplier / Group type | What they typically supply | Notes for sourcing diligence |
|---|---|---|
| Bulk chemical producers | Benzoyl peroxide (industrial/pharma-ready grades) | Requires strong control of moisture, particle size distribution, and stabilizers |
| API/chemical hybrid suppliers | Benzoyl peroxide plus specialty grades | Used when formulations demand tighter PSD and consistent decomposition behavior |
| Finished product ingredient distributors | Benzoyl peroxide and solvent blends | Depends on documented hazard handling and shipping controls (thermo-stability, transport class) |
| Multiple-region chemical supply | Benzoyl peroxide for EU/US | Often supported via parallel qualifying sites to manage availability |
Sourcing reality for business: benzoyl peroxide has broad chemical supply capacity, but pharma-grade acceptance depends on stable assay, impurity profile, particle size control, and controlled storage/shipping.
Which supplier categories matter most for regulated ERYTHROMYCIN + BENZOYL PEROXIDE products?
For combination topical acne products, sourcing must cover both materials and the “regulatory readiness” of each supplier. The critical categories are:
-
Quality system maturity
- GMP capability for API/intermediates
- Batch documentation completeness (CoA, impurity profile, stability data when required)
-
Specification discipline
- Erythromycin: assay potency, relevant impurities, water content, residual solvents (if applicable), microbiological quality
- Benzoyl peroxide: assay, active oxygen/available oxygen measures when used, impurity limits, decomposition-related parameters, particle size (when specified)
-
Consistency controls
- Controlled particle size and bulk density for BPO (often a key driver of formulation performance)
- Consistent polymorph/grade control for erythromycin API (where applicable to the supplier’s internal grade)
-
Supply continuity
- Dual-source qualification path
- Ability to provide compliant documentation for each shipment
Where do suppliers sit in the value chain?
Erythromycin supply chain typically goes:
- fermentation and antibiotic intermediate processing
- API crystallization/purification
- API packaging and documentation for pharma use
Benzoyl peroxide supply chain typically goes:
- benzoyl chloride/related feed conversion
- peroxide synthesis and purification
- stabilization, grade selection, packaging under hazardous goods controls
These differences drive different supplier risks:
- Erythromycin risk: API impurity profile and batch-to-batch potency consistency
- BPO risk: hazardous handling capability and physicochemical consistency (especially particle size and stability during storage/transport)
What supplier strategy supports both materials in one program?
A robust approach for combination product manufacturing is to qualify suppliers in a way that reduces operational risk:
- Dual-source API: qualify two erythromycin API sites for continuity
- Dual-source BPO grades: qualify at least one backup with compatible particle size/stability profile
- Distributor vs direct: direct supplier qualification reduces variability; distributor procurement can shorten lead times but requires stronger incoming QC and qualification paperwork discipline
- Documentation alignment: ensure supplier CoAs and specifications match your internal specs before scale-up
What supplier information is typically required for qualification?
Even when suppliers are known, qualification is driven by documentation and spec alignment.
For erythromycin API, manufacturers commonly require:
- GMP certificate (or equivalent regulatory status)
- CoA per batch
- specification sheet (assay, impurities, residual solvents if relevant)
- analytical methods (or reference to approved pharmacopeial methods)
- stability summary and storage conditions
- change control notifications process
For benzoyl peroxide, manufacturers commonly require:
- GMP/quality documentation for pharma grade
- CoA per batch and assay control limits
- impurity/decomposition-related parameters
- particle size/bulk density information where relevant
- shipping/stability protocol for hazardous goods handling
Key Takeaways
- Erythromycin API supply concentrates in global API manufacturers and their distributors; benzoyl peroxide supply is broader across chemical producers, with pharma acceptance driven by grade consistency and hazardous goods handling.
- Supplier selection for ERYTHROMYCIN + BENZOYL PEROXIDE is less about brand recognition and more about qualification readiness: GMP status, spec discipline, and batch consistency.
- A dual-source model for both materials reduces manufacturing downtime risk when either API or BPO supply tightens.
FAQs
-
Do erythromycin and benzoyl peroxide need to be sourced from GMP suppliers?
For regulated topical pharmaceutical manufacturing, both inputs must come from suppliers with pharmaceutical quality systems capable of providing compliant CoAs and specifications. -
What is the main supplier risk for benzoyl peroxide?
Physicochemical variability (assay stability and particle characteristics) plus hazardous transport and storage handling. -
How should manufacturers approach dual sourcing for this combination?
Qualify at least two supplier sites for erythromycin API and at least one backup benzoyl peroxide grade that matches formulation-relevant physicochemical properties. -
Can distributors be used instead of qualifying suppliers directly?
Distributors can reduce lead time, but qualification must still verify GMP status, consistent specifications, and complete shipment documentation for each batch. -
What documents drive acceptance during supplier qualification?
CoA, specification sheets, analytical method references, GMP/quality system evidence, stability and storage guidance, and change control procedures.
References
[1] U.S. Food and Drug Administration (FDA). Drug master files (DMFs) and regulatory guidance related to active pharmaceutical ingredients and related quality documentation. FDA website.
[2] European Medicines Agency (EMA). Guidelines on starting materials and GMP expectations for APIs and related substances. EMA website.
[3] World Health Organization (WHO). Quality assurance of pharmaceuticals: GMP and quality documentation practices for APIs and excipient-like substances. WHO publications.
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