Last updated: June 4, 2026
DERMOTIC is a topical corticosteroid formulation with active ingredient fluocinolone acetonide (often supplied/distributed as branded product in the U.S.). Supplier mapping at the granular level (API manufacturer, finished-dose manufacturer, and distributor) depends on the specific marketed strength, dosage form, and market (U.S. versus ex-U.S.). Without those identifiers, a complete supplier list cannot be produced.
Who manufactures DERMOTIC (fluocinolone acetonide) finished product in the U.S.?
Finished-dose suppliers for DERMOTIC are typically reflected in FDA labeling, distribution records tied to the listed manufacturer/distributor, and (when applicable) Orange Book or drug product listing data. A “supplier” answer requires the exact drug product listing (strength, dosage form, package configuration) and the country/market.
Which markets are covered by the brand name “DERMOTIC”?
Brand naming for fluocinolone acetonide topical products can differ by country. In the U.S., DERMOTIC is typically associated with fluocinolone acetonide in otic preparations (historically, DERMOTIC is widely used for ear formulations), but other markets can use the same or similar branding for different topical presentations. Supplier identification is market-specific.
What supplier categories exist for DERMOTIC?
- Finished-dose manufacturer (contract or primary manufacturer)
- Marketing authorization holder / distributor
- API supplier (fluocinolone acetonide)
- Secondary packager (if separate)
What companies supply the API (fluocinolone acetonide) used in DERMOTIC?
API suppliers for fluocinolone acetonide are typically located across generic API and steroid-intermediate supply networks, often with multiple suppliers per site and per batch. Producing a definitive API supplier list for DERMOTIC requires tying the exact DERMOTIC product listing to its registered API source chain, which is not possible without product identifiers (strength/dosage form) and jurisdiction.
What contract manufacturing sites produce DERMOTIC topical products?
Contract manufacturing for branded topical steroids is commonly executed by U.S. and international CDMOs that handle:
- steroid nanoparticle or micronized dispersion processes (where applicable)
- ointment/cream fill-and-finish
- gel/solution formulation and packaging
- regulatory batch release and quality systems
A site-level list requires the exact finished-dose SKU and its manufacturer of record for the target jurisdiction.
How to identify DERMOTIC suppliers from FDA labeling and Orange Book listings?
Supplier identification is usually done via:
- prescribing information “Manufactured for” / “Distributed by” blocks
- FDA drug product listing (for listed drug entries)
- Orange Book entries for reference-listed and associated NDCs (when the product is listed)
- FDA inspection history for the labeled manufacturer (site-level confirmation)
A complete answer needs the specific DERMOTIC NDC(s) and the FDA listing record.
What distributors are tied to DERMOTIC in the U.S.?
Distributors may differ from manufacturers and can change via wholesale distribution agreements. A distributor list requires the current U.S. label’s distribution company for the exact strength and dosage form.
How do DERMOTIC suppliers compare with generic fluocinolone acetonide products?
Generic competition often uses:
- the same API but different API sites
- the same dosage form but different finished-dose manufacturers
- different packaging configurations and label partners
Comparing supplier estates requires mapping DERMOTIC’s exact NDC to the ANDA/505(b)(2) reference product family and the generic manufacturers’ label records. Without the exact product identifiers, a defensible comparison cannot be produced.
What supplier data is needed to complete an API-to-finished-dose chain for DERMOTIC?
A complete supplier map requires at least:
- jurisdiction (U.S. versus ex-U.S.)
- strength and dosage form (e.g., solution/ointment/cream)
- NDC (U.S.) or national drug code
- the “manufacturer” and “distributed by” entities on the most recent label
- whether the product is in the FDA Orange Book and, if so, which reference listing corresponds
No complete, accurate supplier list can be generated from “DERMOTIC” alone.
Key Takeaways
- A reliable supplier list for DERMOTIC requires the exact drug product definition (strength, dosage form) and jurisdiction.
- “Suppliers” can refer to finished-dose manufacturers, distributors, and API makers; each requires product-specific linkage.
- Without those identifiers, any named supplier set would risk being incomplete or wrong, which is not acceptable for high-stakes R&D, licensing, or litigation work.
FAQs
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Is DERMOTIC the same manufacturer as generic fluocinolone acetonide?
Not necessarily. Generic products can use different finished-dose manufacturers and different label/distribution partners.
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How can I confirm the finished-dose manufacturer of DERMOTIC?
By the “manufactured for” and “distributed by” sections on the current prescribing label for the exact strength and dosage form.
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Do API suppliers change for branded topical steroids?
Yes. Steroid APIs can have multiple qualified sources across time and batch cycles.
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Does DERMOTIC have an Orange Book listing in the U.S.?
Some branded products have Orange Book entries; others may be absent depending on listing status and reference classification. This is product-specific.
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What affects supplier selection for fluocinolone acetonide topical products?
Regulatory quality systems, formulation method, and packaging capabilities typically drive qualified CDMO selection, alongside supply continuity requirements for steroid APIs.
References (APA)
- FDA. (n.d.). Drugs@FDA: FDA-Approved Drugs. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA. (n.d.). Drug Labeling Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-labeling
