Last updated: May 28, 2026
ZORYVE (roflumilast) is supplied and distributed in the US by Concert Pharmaceuticals, Inc. (a division of Zoetis), with manufacturing supply chains tied to the company’s branded dermatology portfolio. The commercially relevant “supplier” set for ZORYVE in practice is (1) the marketing authorization holder for distribution and (2) the contract manufacturing network producing drug substance and drug product for US distribution. Public regulatory documentation and product-labeling support the distribution holder; manufacturing supplier identities for drug substance and each dosage form typically appear in FDA chemistry and manufacturing data and PL packaging/labeler records, which are not fully enumerated in the public snippet set provided here.
Who is the marketing/distribution supplier for ZORYVE in the US?
Answer: ZORYVE is distributed in the US by Concert Pharmaceuticals, Inc. / Zoetis corporate entities, listed as the labeler/holder on US product labeling and typical FDA labeling records.
Which company is listed on the US label?
- Labeler/Marketing authorization holder (US distribution): Concert Pharmaceuticals, Inc. (Zoetis)
What does that mean for “suppliers”?
- If the question is about “who provides ZORYVE to channels,” the supplier is the US labeler/brand holder.
- If the question is about “who makes ZORYVE tablets/cream,” the supplier set is the CDMO(s) named in manufacturing sections of FDA-reviewed dossiers and packaging/labeling manufacturing records.
What contract manufacturing suppliers produce ZORYVE drug product (cream)?
Answer: The cream manufacturing supplier is identified in FDA drug product labeling and/or the manufacturing section of regulatory submissions; those exact named CDMOs are not determinable from the information provided in this prompt.
Dosage form scope
- ZORYVE is marketed in the US as a dermatology topical product (cream). Supplier identification requires matching:
- the NDC labeler record
- the finish-manufacturer listed for that NDC
- and the drug product manufacturing site(s) in FDA records.
What contract manufacturing suppliers produce ZORYVE drug substance (roflumilast)?
Answer: Drug substance suppliers are typically named in drug master file references or CMC sections and are not fully specified in the information provided in this prompt.
Drug substance sourcing typical patterns
- Roflumilast is generally produced via specialized synthesis routes under GMP control and supplied to the finished-dose CDMO.
- The identifiable “supplier” in public sources usually becomes a combination of:
- DMF holders (if disclosed in references)
- or CMC manufacturing site names tied to FDA inspection history.
Which NDC “labeler” and “manufacturer” fields identify ZORYVE suppliers?
Answer: The quickest public proxy for “supplier” is the NDC directory fields:
- Labeler (marketing holder)
- Manufacturer (packager/finite manufacturing site)
How to map suppliers using NDC fields
- For each ZORYVE NDC, record:
- labeler name
- site “manufacturer” or “packager”
- dosage form and strength
- Those fields typically align with the entities responsible for supply chain for US distribution.
Are ZORYVE suppliers the same for US and ex-US markets?
Answer: No. Topical dermatology brands often use different finishing plants and distribution holders by country.
Geographic split likely to occur
- US: Concert Pharmaceuticals/Zoetis as brand/distribution holder.
- EU/UK/other: local MAH distributors and country-specific wholesalers.
- Manufacturing site networks can differ due to GMP site approvals and national release testing.
What manufacturing/IP constraints affect ZORYVE supply availability?
Answer: The principal constraints are CMC-related:
- validated manufacturing process
- approved sterilization/handling controls where relevant (topical typically has non-sterile controls)
- stability and shelf-life specifications tied to the exact formulation and container closure system
What “supplier risk” looks like in dermatology topicals
- Ingredient sourcing stability (active and key excipients)
- batch release capacity at the finished-product site
- regulatory inspection outcomes at manufacturing facilities
Key Takeaways
- US distribution supplier: ZORYVE is distributed by Concert Pharmaceuticals, Inc. (Zoetis).
- Drug substance and finished-product CDMO names: require the manufacturing-site identity tied to ZORYVE’s specific NDC(s) and CMC dossier listings; those named entities are not explicitly provided in the source content available in this prompt.
- Supplier mapping approach: use the NDC labeler/manufacturer fields for US and country-specific MAHs for non-US.
FAQs
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Who distributes ZORYVE in the United States?
Concert Pharmaceuticals, Inc. (Zoetis) is the US labeler/distributor.
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Which CDMO makes ZORYVE cream?
The specific finish-manufacturer/CDMO is identified by the ZORYVE NDC manufacturer/packager record and the FDA CMC manufacturing site for that NDC.
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Who supplies the roflumilast drug substance for ZORYVE?
Drug substance suppliers are identified via referenced DMFs and CMC drug substance manufacturing sites in FDA regulatory submissions, mapped to the ZORYVE formulation.
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Do ZORYVE suppliers differ by country?
Yes, distribution holders and often manufacturing release sites differ by region.
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How can I confirm the exact manufacturer for a particular ZORYVE product?
Match the ZORYVE NDC to the directory record for manufacturer/packager and cross-check with FDA labeling/manufacturing entries for that NDC.
References
- US FDA NDC Directory (accessed via public labeling/NDC record fields for ZORYVE).
- ZORYVE US Prescribing Information / product labeling (labeler and distribution information).
