Last updated: May 25, 2026
Claravis suppliers (FDA, manufacturers, and contract manufacturing for isotretinoin)
Claravis is the brand-name formulation of isotretinoin. Supplier mapping depends on which strength and dosage form (typically oral capsules) is being sourced, and on whether supply is coming from the NDA holder’s commercial manufacturer versus authorized contract manufacturers listed on FDA inspections and supply-chain disclosures. Without the specific Claravis product identifiers (strength, labeler, NDC) and an up-to-date Orange Book/FDA labeler trace, a complete, accuracy-guaranteed supplier list cannot be produced.
Who manufactures Claravis (isotretinoin) capsules in the US?
Answer: Claravis manufacturing is tied to the product’s FDA labeler and manufacturing site(s). Determining the current manufacturer requires the specific NDC(s) and the FDA label “Manufactured for” / “Distributed by” / “Manufactured by” sections, plus Orange Book listing(s) for the branded product.
What supplier data is used for Claravis manufacturer identification
Commonly used supplier touchpoints for branded US drugs include:
- FDA Orange Book product listings for the NDA (active ingredient, dosage form, strength)
- FDA labeler data for each NDC/label
- Site-specific manufacturing disclosed on the label and in recent FDA establishment inspection records
What companies supply isotretinoin for Claravis under contract manufacturing?
Answer: Contract manufacturers for Claravis are identified through the same labeling and inspection establishment trail. Without the current labeled manufacturing establishment(s) for each Claravis NDC/strength, a factual supplier list cannot be compiled.
Where contract manufacturing usually appears
- Label section “Manufactured for” and the listed establishment address
- FDA drug establishment registrations for isotretinoin product manufacturing
- Public settlement and supply disclosures in generic/brand disputes (rare for this brand unless litigation is active)
What is the Orange Book status of Claravis and does it list manufacturing sites?
Answer: Orange Book is used to confirm the NDA and listed drug status and associated patent entries; it does not reliably provide a full site-by-site supply chain. It is typically the starting point to map the correct product/label set, after which labeling and FDA establishment data are used for supplier identification.
Which Orange Book fields matter for supplier mapping
- NDA number tied to Claravis
- Dosage form and strength entries
- Listed patents and whether any are tied to specific formulation changes (which can trigger different manufacturing/scale-up sources)
When does Claravis lose exclusivity and can that change suppliers?
Answer: Exclusivity loss can affect commercial supply dynamics, but it does not by itself identify “suppliers.” Supplier changes usually reflect:
- labeler and manufacturing site shifts
- batch-specific sourcing
- contract renewals
Accurate exclusivity-timeline mapping requires the specific listed Claravis NDA and its exclusivity/patent record.
Which suppliers risk shortages for Claravis (supply chain concentration)?
Answer: The risk is assessed by counting:
- the number of currently active manufacturing establishments for Claravis
- historical FDA warning letters or inspection outcomes affecting those sites
- prior recall or distribution discontinuations by NDC/label
A concentration-risk ranking requires current site-level supplier data, which cannot be generated from the information provided.
How do Claravis suppliers compare with generic isotretinoin suppliers?
Answer: Generic isotretinoin supply is distributed across multiple abbreviated approval manufacturers. Comparing supplier bases is an NDA-level and NDC-level exercise and requires:
- Claravis labeler/manufacturers
- generic competitors’ labelers/manufacturers for the same strength/form
- any shared API intermediates or finished-dose sites
No current labeler mapping is available here to support a factual comparison.
What generic entry risks exist for Claravis suppliers?
Answer: Generic entry risk is driven by:
- patent and exclusivity status
- FDA approval pathway (ANDA suitability)
- litigation outcomes and settlements
Supplier risk is downstream and cannot be tied to specific suppliers without the current Orange Book and litigation record for Claravis and then the exact manufacturing site list.
What formulations are protected for Claravis and do they affect sourcing?
Answer: If Claravis has line extensions, formulation changes, or manufacturing-method patents, sourcing can shift. Determining whether sourcing changes are legally required depends on:
- patent claims tied to formulation/process
- whether generics are attempting “skinny” approvals or carve-outs
No formulation/patent-to-sourcing mapping can be produced from the information provided.
Key Takeaways
- Claravis supplier identification requires NDC/strength-specific manufacturer and labeler data.
- Without the specific Claravis product identifiers and the current FDA labeler/manufacturing site listings, an accuracy-guaranteed supplier list cannot be produced.
FAQs
- How do I identify the actual Claravis capsule manufacturer for a specific NDC?
- Do Claravis suppliers change by strength or capsule size?
- Where can I verify Claravis manufacturing sites besides the label?
- How do Claravis patent challenges influence manufacturer or labeler decisions?
- What is the fastest way to audit Claravis supply chain concentration?
References
(No sources cited because supplier-manufacturer facts for Claravis were not provided in the prompt.)
