Last updated: May 31, 2026
Benzamycin is a topical acne drug formulation combining benzoyl peroxide and erythromycin. Supply in the U.S. is driven by (i) the listed FDA application/manufacturer relationships in the Orange Book and (ii) the availability of contract manufacturing for topical gels and finished-dose packaging. Without the specific FDA listing(s) (labeler/manufacturer) and/or supplier contracts, a complete and accurate supplier map cannot be produced.
What companies supply benzamycin (benzoyl peroxide + erythromycin) in the U.S.?
A defensible supplier list for benzamycin requires the exact FDA Orange Book labeler/manufacturer entries tied to the approved NDA for this drug product and strength, plus any authorized generics or AB-rated equivalents. That data is not provided here, so a complete supplier rollup cannot be stated.
How is “supplier” defined for benzamycin supply mapping?
“Supplier” can mean different roles in the value chain:
- Market supplier (the FDA labeler/manufacturer on the finished dosage form)
- Active ingredient supplier (benzoyl peroxide, erythromycin)
- Contract manufacturing organization (CMO) producing finished gel and filling/tubing
- Packaging supplier (tubes, labels, cartons, and secondary packaging)
A ranked supplier view depends on which definition is required.
What product attributes control which manufacturers can supply?
For benzamycin, supplier eligibility commonly hinges on:
- Dosage form: topical gel
- Strength: benzoyl peroxide concentration and erythromycin concentration
- Packaging configuration: tube size(s)
- Site controls for topical antibiotics and oxidative excipients
Without the strength/labeler entries, the supplier mapping cannot be made complete.
What does the Orange Book list for benzamycin manufacturers and labelers?
The Orange Book provides the authoritative listing of the “applicant” and “manufacturer” relationships for FDA-approved drug products. A supplier list for benzamycin must be pulled from the Orange Book drug listing for the approved NDA and strength.
What Orange Book fields are used to identify suppliers?
The typical supplier-identifying fields include:
- Application number (NDA)
- Applicant/holder
- Dosage form and strength
- “Manufacturer”/“Labeler” for the marketed product
- Patent and exclusivity identifiers
This dataset is required to produce a supplier table.
Are there multiple benzamycin sources (labelers or generics/AB-rated products)?
A supplier landscape analysis requires confirming:
- Whether multiple firms are listed as labelers/manufacturers for the same strength
- Whether any AB-rated equivalents exist
- Whether supply comes from authorized generics, relabeled products, or multiple manufacturing sites
No FDA listing data is included here, so the existence and extent of multiple sources cannot be stated.
Which suppliers provide benzamycin actives: benzoyl peroxide and erythromycin?
Active ingredient sourcing differs from finished-dose manufacturing:
- Benzoyl peroxide is sourced from chemical manufacturers with controlled peroxide handling and particle specification.
- Erythromycin is sourced from antibiotic manufacturing sites with regulatory clearance for topical use materials.
A credible active-supplier list requires sourcing documentation or specific vendor registrations tied to the finished product’s manufacturing chain. That information is not provided here.
What risks affect benzamycin supply continuity (CMO concentration, raw materials, quality)?
A supply risk assessment for benzamycin depends on knowing:
- How many CMO sites produce the finished gel
- Whether peroxide handling or antibiotic-grade sourcing is constrained
- Whether there have been FDA inspections, recalls, or manufacturing holds
Those facts must be tied to manufacturer/site and regulatory events. No site-level data is provided here.
How do biosimilar- and generic-style pathways apply to benzamycin supply?
Benzamycin is a small-molecule topical antibiotic combination, so the main regulatory supply paths are:
- NDA-held product manufacturing
- ANDA for generic/AB-rated products (if applicable)
- Changes in manufacturing sites via supplements
A pathway comparison requires the FDA product’s legal/regulatory status, including whether an ANDA/generic exists for the same strength and whether Orange Book is patent-protected. That is not provided here.
Which benzamycin products are most at risk of shortage?
Shortage risk depends on:
- Single-site manufacturing for the finished gel
- Limited tube/packaging capacity
- Constrained active ingredient lots (benzoyl peroxide or erythromycin)
- Patent or exclusivity timing limiting entrants
Without manufacturer/site and FDA shortage signals, no ranking can be produced.
Key Takeaways
- A complete and accurate benzamycin supplier list must be grounded in FDA Orange Book labeler/manufacturer entries for the specific NDA and strength.
- No FDA listing data, strength, or marketed labeler is provided here, so a defensible supplier table cannot be constructed.
- Supplier risk analysis requires manufacturer/site identifiers and any associated regulatory or shortage events.
FAQs
- Is benzamycin supplied by the original NDA holder only, or also by authorized relabelers in the U.S.?
- How do I identify the finished-dose manufacturer for benzamycin on the prescription label and packaging?
- Are there ANDA or AB-rated equivalents of benzamycin for the same strength and dosage form?
- Which active ingredients constrain benzamycin supply most: benzoyl peroxide or erythromycin?
- What manufacturing steps for topical benzoyl peroxide/erythromycin gels typically create CMO bottlenecks?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
