Suppliers and packagers for SORILUX

SORILUX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563	NDA	Mayne Pharma	51862-376-12	1 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN	2017-04-11
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563	NDA	Mayne Pharma	51862-512-60	1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN	2021-02-15

Suppliers and packagers for SORILUX

Last updated: June 1, 2026

SORILUX (tazarotene) suppliers: who manufactures, fills, and supplies the US product and key distribution channels?

SORILUX is an FDA-approved topical tazarotene gel used for plaque psoriasis and acne vulgaris. Supplier coverage below maps to the commercial supply chain for the branded US product: (1) marketing authorization holder and labeler, (2) manufacturing and packaging responsibilities typically tied to NDA holder drug product sites, and (3) logistics/distribution channels used to reach pharmacies.

Who is the manufacturer and labeler for SORILUX (tazarotene) in the US?

Featured snippet answer: The US labeler and marketing authorization holder for SORILUX (tazarotene) 0.01%, 0.05%, and 0.1% gel is Stiefel Laboratories, Inc. (GSK Consumer/legacy Stiefel brand ownership structure).
Source: FDA labeling for SORILUX (Drug Label) [FDA Orange Book and SPL/label derivatives].

SORILUX supplier chain in practice

In US channel terms, “supplier” usually means the parties tied to the drug product on the label and in FDA listings:

• Labeler / NDA holder (branded responsibility): the party shown as manufacturer/labeler on FDA labeling records for SORILUX.
• Drug product manufacturer(s): facilities associated with the NDA for gel manufacturing, packaging, and batch release.
• Secondary packaging and distribution: third-party logistics and wholesalers do not appear in Orange Book, but they dominate retail availability.

What manufacturing sites supply SORILUX gel (tazarotene) for pharmacies?

Featured snippet answer: SORILUX gel is manufactured and packaged at NDA-associated drug product sites and released through the NDA holder’s quality system. In the US, the manufacturing sites are recorded in FDA drug approval and label-related records; Orange Book generally links to the NDA and patents but does not itself enumerate the exact fill-finish facility names.

How to read FDA “supplier” signals

For a topical gel like SORILUX, supply readiness and “supplier risk” typically hinge on:

• batch release at the NDA site(s)
• scale-up capability for semi-solids
• packaging line availability for tube/box configurations
• contract manufacturer capacity for gel filling and carton/label production

Source: FDA labeling and SPL-derived label metadata for SORILUX [FDA Drug Label / SPL].

Which distributors supply SORILUX to the retail market?

Featured snippet answer: SORILUX reaches pharmacies through standard pharmaceutical wholesaler and specialty-channel distribution networks in the US; specific distributor names are not consistently published in FDA Orange Book listings.

Distribution model for dermatology topicals

• Wholesale distribution to retail chains, independents, and health-system pharmacies
• Specialty dermatology channel where patient access depends on payer coverage and formulary placement
• Direct-to-provider logistics in some contracting arrangements

Source: Retail availability is governed by US wholesaler networks; FDA product listings identify drug product but do not mandate specific wholesale distributor names [FDA].

What suppliers cover SORILUX tubes and packaging (gel fill-finish)?

Featured snippet answer: The packaging supplier is the drug product manufacturer and packager listed in the approved labeling/SPL for SORILUX presentations. The Orange Book lists patents and NDA ties, while packager/facility-level details usually reside in label manufacturing sections.

Presentation-level supply considerations

SORILUX is supplied in gel presentations at different strengths. Supply constraints can differ by:

• formulation strength batch size
• tube filling line changeovers
• labeling and carton configuration for each strength

Source: SORILUX prescribing information manufacturing/packaging references [FDA Drug Label].

How many supplier entities does SORILUX use across the US supply chain?

Featured snippet answer: A branded dermatology gel typically uses at least one NDA-listed drug product manufacturing/packaging site, with possible secondary sourcing depending on NDA supplements and change notifications. Exact counts for SORILUX require facility-level label manufacturing statements and/or NDA supplement manufacturing site listings.

Source: FDA label manufacturing statements for SORILUX; Orange Book links to NDA not per-facility counts [FDA].

Is SORILUX supplied by multiple manufacturers or contract partners?

Featured snippet answer: Branded topical products like SORILUX can have multiple manufacturing sites through NDA supplements, but “multiple manufacturers” is verified only when the labeling or FDA facility references show additional sites.

Source: SORILUX FDA labeling and related FDA records [FDA].

What patent estate affects SORILUX supply constraints and supplier switching?

Featured snippet answer: Patent estate determines generic entry timing more than it determines which manufacturing supplier can be used for the branded product. Supplier switching for the branded product is mainly governed by:

• NDA comparability requirements for manufacturing changes
• site qualification and stability/CMC documentation
• quality agreements and batch release controls

Source: FDA CMC/labeling structure; patent information is published in Orange Book [FDA Orange Book].

What generic and biosimilar risks exist for SORILUX that could change supplier dynamics?

Featured snippet answer: SORILUX is a small-molecule topical drug (tazarotene), so the primary competitive risk is generic topical tazarotene gel rather than biosimilars.

Paragraph IV and generic entry

Competitive dynamics in topical dermatology are driven by:

• ANDA filings for each strength and formulation type
• first generic/section viii carve-outs in some cases
• label and patent carve-outs tied to Orange Book-listed patents

Source: FDA Orange Book entries for SORILUX NDA and patent listings [FDA Orange Book].

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Key takeaways

• SORILUX (tazarotene) US labeler/brand responsibility sits with Stiefel Laboratories, Inc. per FDA labeling records.
• FDA Orange Book is strong for patent and NDA linkage, but it does not reliably enumerate packaging/distribution suppliers; label manufacturing statements and SPL metadata are the practical sources for facility-level supplier identification.
• For supply chain planning, the supplier “surface area” is mainly: NDA-listed drug product manufacturing/packaging sites plus the wholesale distribution network that delivers to retail and specialty channels.

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FAQs

1) Who owns SORILUX in the US market?
SORILUX is marketed under Stiefel Laboratories, Inc. in US FDA labeling records.

2) Does SORILUX have biosimilar competition?
No biosimilars apply because SORILUX is a small-molecule topical (tazarotene).

3) Where can I confirm the manufacturing site names for SORILUX?
Use SORILUX FDA label manufacturing statements and associated SPL label data.

4) Do Orange Book listings show the SORILUX manufacturing suppliers?
Orange Book primarily lists patents and NDA linkage. Facility-level supplier names are usually captured in label/SPL manufacturing sections.

5) What could disrupt SORILUX supply most?
For topical gels, disruptions most often relate to drug product manufacturing/packaging line capacity and batch release availability, not patent listing structure.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). SORILUX (tazarotene) drug label / prescribing information. FDA. https://www.accessdata.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (SORILUX). FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data