Last updated: May 27, 2026
ARAZLO is a topical tazarotene gel. Commercial supply is typically organized across three layers: (1) active pharmaceutical ingredient (API) manufacturing of tazarotene, (2) finished-goods manufacturing and formulation (gel filling/packaging), and (3) secondary services including packaging and distribution.
Which companies are suppliers for ARAZLO (tazarotene) in the US?
No complete supplier roster for ARAZLO can be stated from the information available in this workspace. AAZLO’s supplier identification requires at least one of the following: FDA facility inspection listings tied to ARAZLO application/label, the Orange Book “Manufacturers” entries for the listed drug, FDA drug product application labeling with manufacturer/packer details, or executed sourcing disclosures (for example, DMFs and the listed manufacturer of record). This data is not present here.
What does the ARAZLO label list for manufacturers, packers, and distributors?
ARAZLO’s US prescribing information generally identifies separate entities for:
- Manufacturing site (drug product manufacturer)
- Packer (if different from manufacturer)
- Distributor / holder (often the marketing authorization holder or US distributor)
Those named entities are not available in the provided material here, so a manufacturer-by-manufacturer supplier table cannot be produced.
What label entities matter for supplier diligence?
- Drug product manufacturer (gel manufacture and filling)
- Site responsible for release testing
- Labeler/distributor (market-facing entity)
- Packaging manufacturer (tube, carton, leaflet production, labeling)
How do you map ARAZLO supply chains using FDA databases (Orange Book, SPL, inspections)?
A supplier map requires database pulls from FDA sources that are not included here, including:
- Orange Book listing for ARAZLO (drug product “Manufacturer” / “Labeler” fields)
- SPL (Structured Product Labeling) for ARAZLO (listed manufacturer and packager)
- Drug establishment registration and listing for relevant product code(s)
- FDA inspection databases linked to the application and facility identifiers
Without those datasets, there is no defensible company-to-process mapping for ARAZLO supply.
What are the typical API and gel manufacturing roles for tazarotene suppliers?
For a topical tazarotene gel, the supply structure usually breaks into:
- API tazarotene synthesis: chemical route to tazarotene (bulk API)
- Gel formulation: combining tazarotene with the gel base, excipients, and stabilizers
- Filling and packaging: filling tubes or pumps, applying labels, and carton/leaflet assembly
- Quality systems: analytical testing, stability programs, and sterility is typically not relevant for gels but microbial limits are
Company names for these steps for ARAZLO cannot be listed without source documents tying the product to specific facilities.
How many supplier sites support ARAZLO, and what drives redundancy?
Supplier redundancy for topical dermatology products is driven by:
- Release-test capacity
- Tube supply constraints (packaging)
- Demand volatility around seasonal acne/psoriasis cycles
- Regulatory compliance history for each site
The count of ARAZLO manufacturing sites and backup suppliers cannot be quantified from the current information.
What supplier risks exist for ARAZLO manufacturing and availability?
Key risk factors in topical gel supply chains include:
- API availability and contract manufacturing capacity for tazarotene
- Gel-base procurement and viscosity control capacity
- Packaging lead times (tube resin, closures, labeling systems)
- Quality system failures that can trigger voluntary or FDA-enforced hold
Specific ARAZLO supplier risks (by company) require facility- and contract-level disclosures that are not present here.
Key Takeaways
- ARAZLO supply involves API manufacturing, gel formulation/filling, and packaging/distribution roles.
- A defensible company-level supplier roster for ARAZLO cannot be produced from the information provided in this workspace.
- Supplier diligence should rely on Orange Book/SPL/establishment registration and inspection-linked facility identifiers, then map entities to drug product and packaging functions.
FAQs
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Where can I find the official manufacturer and packager for ARAZLO?
In ARAZLO’s FDA SPL and prescribing information label “Manufactured for/Distributed by” and “Manufactured at” sections.
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Can I identify ARAZLO suppliers from the Orange Book alone?
Orange Book can show product “Manufacturer/Labeler” fields, but full supplier identification for API and secondary packaging often requires SPL and facility registration/DMF mapping.
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Do ARAZLO and other tazarotene gels share the same supplier sites?
They can, but site sharing must be confirmed from product-specific labeling and FDA facility listings.
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How do packaging suppliers affect ARAZLO continuity?
Tube, closure, and labeling components can drive lead times and constrain manufacturing schedules even when API and formulation capacity are available.
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What evidence best supports a claim about the ARAZLO contract manufacturing company?
The labeled “Manufactured at”/site address in FDA SPL, and the registered facility in FDA drug establishment records tied to the product.
References
No sources were provided in the prompt, and no FDA label/Orange Book/SPL/inspection extracts are available in the current workspace to cite.
