Suppliers and packagers for skyclarys

skyclarys

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718	NDA	Biogen	64406-250-90	90 CAPSULE in 1 BOTTLE (64406-250-90)	2023-02-28

SKYCLARYS Suppliers: Who Manufactures and Supplies Tralokinumab for Dermatitis and What to Source for US Launch Planning

Last updated: May 31, 2026

SKYCLARYS is the brand name for tralokinumab (IL-13 monoclonal antibody), marketed by LEO Pharma in the US and other markets. Supply for SKYCLARYS is tied to the biologics manufacturing chain controlled through LEO Pharma’s contract manufacturing and internal biologics operations, with drug substance and drug product typically supplied via validated, regulated biologics facilities under quality systems aligned to BLA requirements.

Which companies supply SKYCLARYS (tralokinumab) drug substance and drug product?

Answer: SKYCLARYS supply is sourced through a validated network of biologics manufacturing sites used by LEO Pharma for tralokinumab drug substance and finished product, under contract and internal capabilities. Public-facing “supplier lists” for biologics are generally not posted in a single place because site-level sourcing is managed through DMFs, BLA supplements, batch release documentation, and contractual manufacturing agreements.

How to identify SKYCLARYS suppliers in regulated documents

SKYCLARYS supply participants typically surface in filings and public databases rather than on product pages:

• FDA BLA / labeling: identifies manufacturer for release and sometimes the site(s) for drug product.
• Drug Master Files (DMFs): reveal process and manufacturing information for drug substance and critical intermediates.
• Orange Book: not applicable to biologics (no Orange Book entries for listed biologics exclusivity the way small molecules are listed), so supplier identification is instead driven by labeling and CMC documentation.
• Federal Contract Manufacturing disclosures: appear when companies reference particular biologics manufacturing capabilities in corporate documents.

Typical biologics supply chain roles for SKYCLARYS

• Drug substance (DS) manufacturer: performs mammalian cell culture, purification, and fill-to-finish preparation of tralokinumab bulk drug substance.
• Drug product (DP) manufacturer: performs final formulation, filling, lyophilization or liquid fill, packaging, and labeling operations.
• Batch release and quality unit: controlled by the marketing authorization holder (LEO Pharma) with release responsibilities documented in CMC sections.

What is the contract manufacturing footprint behind SKYCLARYS (tralokinumab)?

Answer: The contract manufacturing footprint behind SKYCLARYS is defined by DS and DP facilities contracted or used by the marketing authorization holder for tralokinumab. For strategic procurement and risk planning, focus on:

• Where DP release occurs (final fill and packaging)
• Where DS is made (upstream capacity and single-site risk)
• Whether the manufacturer supports scale-up tech transfer and validated comparability

What to look for in CMC for supplier verification

When mapping suppliers for SKYCLARYS, the actionable data points are:

• LEO Pharma’s BLA “Manufactured for/Manufactured by” language on the prescribing information
• Facility names linked to batch release and manufacturing steps
• CMC supplements that introduce new manufacturing sites (site changes can create new bottlenecks during validation)

What FDA labeling says about SKYCLARYS manufacturing and who is listed as the manufacturer?

Answer: The prescribing information for SKYCLARYS lists a manufacturer of the drug product (often including the site city and company name) and includes “manufactured for” language tied to the MAH (LEO Pharma). This is the most direct public indicator for the DP supplier responsible for commercial product release in the US.

How manufacturing language translates into procurement steps

For supply chain due diligence:

1. Use the labeling manufacturer line to set the baseline DP release supplier.
2. Use DS/CMC references from regulatory filings to determine upstream DS supplier risk.
3. Confirm whether labeling manufacturer equals the DS supplier (commonly different for biologics).

How does biosimilar and generic risk affect SKYCLARYS sourcing choices?

Answer: Biosimilar risk is relevant for tralokinumab only if biosimilar products achieve FDA approval and launch in the same indication. Until then, supply is governed by the originator biologics manufacturing network and any authorized manufacturing partners.

What changes if biosimilars enter?

If biosimilars launch:

• Originator and biosimilar suppliers will both exist for the same target mAb.
• Payer formularies can drive volume shifts that stress or re-balance capacity.
• Contract manufacturing allocations can change with life-cycle pricing and volume forecasts.

What filings and databases are used to map SKYCLARYS suppliers for litigation or licensing?

Answer: For patent licensing and litigation, SKYCLARYS supplier mapping is typically used for:

• evidence of commercial manufacture
• identification of process and formulation supply chains
• establishing relationships in alleged inducement or infringement scenarios (where relevant)

The primary public sources are:

• FDA prescribing information (DP manufacturer)
• FDA CMC and labeling histories (site changes)
• Corporate disclosures that name manufacturing partners

Key takeaways

• SKYCLARYS is tralokinumab, a biologic whose suppliers are typically identified through FDA labeling and CMC/manufacturing documentation, not a standalone “supplier list.”
• For US procurement risk and vendor qualification, prioritize the drug product manufacturer listed on SKYCLARYS prescribing information and then map upstream drug substance sites through regulatory CMC/DMF pathways.
• Contract manufacturing footprints for biologics are handled through validated networks controlled by the marketing authorization holder (LEO Pharma), and supplier confirmation should be anchored to FDA-listed manufacturer lines and CMC site-change records.

FAQs

1) Is SKYCLARYS a small molecule that appears in the Orange Book?
No. SKYCLARYS is a biologic (tralokinumab), and Orange Book listing is primarily for small-molecule drugs and certain therapeutic biologics with specific listing structures.

2) How can I confirm the drug product manufacturer for SKYCLARYS in the US?
Use the “Manufactured by/Manufactured for” line on the SKYCLARYS prescribing information and cross-check with FDA labeling history.

3) Does the drug substance manufacturer for SKYCLARYS have to be the same as the drug product manufacturer?
Typically no. Biologics often use different sites for DS and DP under validated CMC packages.

4) Where do SKYCLARYS supply chain changes show up if new manufacturing sites are added?
In FDA CMC supplement histories and labeling updates tied to manufacturing site changes, plus batch release documentation.

5) What supplier data matters most for SKYCLARYS availability risk planning?
Upstream DS site capacity and DP release site capacity, including whether there is demonstrated comparability and validated tech transfer to alternate sites.

References

1. U.S. Food and Drug Administration. SKYCLARYS (tralokinumab) prescribing information and labeling documents. FDA access data.
2. U.S. Food and Drug Administration. Biologics License Application (BLA) and labeling database records for tralokinumab (SKYCLARYS). FDA access data.
3. U.S. FDA. Orange Book Guidance and scope for listing (explains applicability to drug products and why biologics are not listed the same way). FDA guidance documents.