Last updated: May 27, 2026
Renova is a brand of topical tretinoin used for acne and photoaging. Supply in the US is typically handled by branded product marketers and contract manufacturers, but exact “who makes the product” depends on the specific strength (for example, 0.02% or 0.05% tretinoin), package configuration, and current FDA labeling/market authorization holders listed at the NDC level.
Who supplies Renova (tretinoin) in the US market?
Renova supply is organized around the labeled application holder and the manufacturing sites shown on the FDA label and/or listed in the Drug Product listing (NDC Directory) and Orange Book (where applicable).
What to check to identify the actual manufacturer
For a defensible supplier map, the following data fields are the ones that consistently identify the responsible parties:
- NDC Directory: “Labeler” and drug product listing
- FDA label: company name under “Manufactured for/Distributed by” and the site(s) listed under “Manufactured by”
- Orange Book: patent listings do not directly name contract manufacturers, but they confirm product identity and active ingredient strength
- DSCSA (where product history is available commercially): commissioning and serialization traceability
What companies are the labeled manufacturer/distributor for Renova?
A complete supplier list requires the current FDA listing by strength and NDC. Without the specific Renova strength(s) and NDC(s), any named “supplier” set would be incomplete and risks naming parties that do not correspond to the product currently on the shelf.
What contract manufacturers make Renova (tretinoin cream) for the labeler?
For topical tretinoin creams and gels, contract manufacturing typically covers:
- bulk blending (tretinoin is handled as a potent, light- and oxygen-sensitive active)
- emulsification and homogenization for cream bases
- packaging into tubes and cartons with controlled environmental handling
- in-process controls for viscosity, uniformity, and assay
Contract manufacturing names are usually discoverable only by matching:
- FDA label “Manufactured by” statements
- inspection history (FDA Form 483 and Establishment Inspections)
- DSCSA transaction records, if available
How does Renova supply differ by strength (0.02% vs 0.05% tretinoin)?
Renova is sold in distinct strengths, and each strength can have:
- different NDCs
- different labeler/manufacturer details
- different suppliers and release testing arrangements
A supplier assessment therefore must be strength-specific, not brand-only.
What does Orange Book reveal about Renova manufacturing and product identity?
Orange Book listings establish:
- active ingredient
- dosage form
- labeled strength
- patent-relevant identifiers for the specific product
However, Orange Book typically does not provide a contract manufacturer list. It supports product mapping so you do not accidentally apply a supplier profile from one strength, dosage form, or product presentation to another.
What patent estate status affects Renova supply through FDA exclusivity and bottlenecks?
Renova is a legacy topical tretinoin product. Even where patents and exclusivity have expired, supply bottlenecks usually come from:
- formulation manufacturing know-how for the specific cream base
- packaging formats and tube suppliers
- validated analytical methods for tretinoin content and uniformity
- GMP release capacity for dermatology-topical lines
What generic or alternative tretinoin products compete with Renova and who supplies them?
Renova competes with multiple topical tretinoin products (generics and other brands) that may be manufactured by different labelers/contract manufacturers. Supplier overlap happens at the contract-manufacturer level more than at the brand level, but the only accurate way to identify overlap is to compare:
- NDC-to-labeler and NDC-to-manufacturer label statements
- manufacturing site addresses across multiple tretinoin products
How to build a litigation-proof Renova supplier list (for procurement, licensing, or due diligence)
A procurement-grade supplier dossier for Renova should include:
- NDC(s) per strength and package configuration
- labeler and manufacturer names exactly as shown on the FDA label
- manufacturing site addresses from the label
- establishment identifiers from FDA listings/inspection records
- quality agreement references (where available via customer qualification packages)
- product-specific stability and packaging compatibility notes for tretinoin
Key Takeaways
- “Renova suppliers” are best identified at the NDC level, not as a brand-only label.
- The authoritative supplier identification usually comes from FDA label “Manufactured by” / “Manufactured for” and the NDC Directory labeler.
- Orange Book supports product identity, not typically contract-manufacturer identification.
- A complete supplier map must be strength- and NDC-specific to avoid misattributing the wrong manufacturer.
FAQs
- How do I identify the Renova manufacturer from the NDC Directory?
- Does Renova’s supplier change by strength or package size?
- What documents prove Renova’s real manufacturing site for procurement?
- Which FDA databases should be used to cross-check Renova product identity and labeling?
- Do Renova and other topical tretinoin products share contract manufacturers?
References
(No sources can be cited because no Renova strength, NDC, manufacturer label text, or FDA listing identifiers were provided.)
