Suppliers and packagers for SKLICE

SKLICE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736	NDA	Azurity Pharmaceuticals	24338-185-04	1 TUBE in 1 CARTON (24338-185-04) / 117 g in 1 TUBE	2022-08-31

SKLICE suppliers: Which CMOs, fill-finish partners, and raw-material vendors support the varicella-zoster virus (Oka/Merck) live attenuated vaccine supply chain?

Last updated: May 23, 2026

Which companies supply SKLICE (varicella-zoster virus) drug substance and bulk vaccine?

Answer: The public record typically identifies the marketing authorization holder and the primary manufacturing sites, but does not consistently publish a complete tier-1 supplier list (drug substance, excipients, and raw materials) in public-facing sources. For SKLICE, supply-chain visibility is strongest at the level of approved manufacturing sites listed in regulatory filings and label/manufacturing disclosures, not at the level of every upstream excipient and raw-material vendor.

What is publicly identifiable

• SKLICE is a live attenuated varicella-zoster virus (Oka/Merck) vaccine. Its “supplier” footprint in public sources is usually expressed as:
  • the company marketing the product,
  • the company responsible for bulk manufacture of the vaccine,
  • and the company performing final fill and finish at licensed facilities.

Practical implication for supplier sourcing

• For commercial procurement, licensing, or litigation due diligence, SKLICE supplier mapping usually resolves to:
  • site-level manufacturers (licensed manufacturing plants named in FDA product labeling and review documentation),
  • with additional vendor names appearing only in higher-sensitivity documentation (Master Batch Records, DMF-linked excipient listings, or confidential contracts).

What does the FDA label/manufacturing disclosure say about SKLICE production sites?

Answer: The FDA-approved product labeling for SKLICE identifies manufacturers by name and location for drug product manufacture and packaging. Those named entities are the most defensible “suppliers” for SKLICE in public sources.

Drug product manufacturing disclosures to extract

• Final drug product manufacturing and packaging sites
• Labeling/packaging responsibilities (if different entities)
• Storage and handling instructions that often align with the manufacturing chain

Downstream access

• Once the label-disclosed site is identified, supplier due diligence typically follows with:
  • inspection history,
  • license status,
  • and whether the site is also the listed manufacturer of comparably scoped biologics (same platform, same viral-batch logistics).

Which CMOs perform fill-finish for SKLICE?

Answer: Fill-finish partners are usually named on the FDA label or in FDA manufacturing sections, but specific CMO brand names are not uniformly published across all SKLICE documentation in public sources.

Typical approach used in the market

• Identify the label-listed manufacturer for “manufactured by” or “distributed by.”
• Cross-check whether the labeled entity operates:
  • a licensed biologics manufacturing facility for live virus drug product,
  • and whether they have a dedicated fill-finish biologics suite (commonly in multi-use lines with stringent viral contamination controls).

Procurement risk

• Live attenuated virus vaccines impose tighter controls on:
  • biological containment and cleaning validation,
  • lot segregation and travel,
  • and cold-chain requirements at fill and finish.
• This typically limits the number of qualified fill-finish CMOs.

What raw excipients and buffer systems are used in SKLICE, and who supplies them?

Answer: SKLICE contains stabilizers and formulation excipients typical of live attenuated viral vaccines; however, the label does not always list individual vendor identities for those excipients.

Where supplier identity shows up

• Excipients vendors are more often identifiable via:
  • DMFs (Drug Master Files) cross-referenced to the product,
  • historical comparability packages,
  • and regulatory submission appendices.
• Public sources often stop at the excipient name and concentration, not the commercial supplier.

Commercial consequence

• In sourcing, procurement teams treat excipient risk as:
  • specification risk (particle size, residuals, sterility assurance levels),
  • and supply continuity risk (single-source stabilizers for live virus).

How can you map SKLICE suppliers using FDA approval and inspection records?

Answer: The most defensible supplier mapping method uses:

• the FDA label “manufactured by” site names, and
• the FDA Establishment Inspection Reports (EIRs) where available in public inspection summaries, to build a shortlist of manufacturing entities that can credibly be treated as SKLICE suppliers.

Supplier mapping workflow used for biologics

• Step 1: Pull label “manufacturer” and “distributor” entities and locations.
• Step 2: Check whether those sites appear in:
  • Biologics License Application manufacturing facility lists,
  • inspection histories for the relevant product category.
• Step 3: Identify contract relationships only when publicly evidenced (e.g., co-manufacturing disclosures on label, or named entities in regulatory decisions).

Which companies are listed as SKLICE manufacturers/distributors in public documentation?

Answer: Public SKLICE supplier visibility is usually highest at the level of:

• marketing authorization holder and product distributor,
• and the named manufacturers responsible for manufacturing/packaging.

Why this matters for licensing and litigation

• Patent litigation, regulatory exclusivity challenges, and procurement disputes depend on:
  • who performed the manufacturing step at issue,
  • and which entity controls the manufacturing process and quality system.

Are there Paragraph IV-style IP challenges for SKLICE that affect supplier decisions?

Answer: SKLICE is a biologic vaccine; “Paragraph IV” frameworks are specific to certain FDA generic drug pathways and do not map 1:1 to biologics competition. Supplier decisions are instead driven by:

• biologics license competition pathways (e.g., biosimilar concepts in broader biologics, even though vaccines have unique regulatory paths),
• interchangeability determinations (where applicable),
• and vaccine-specific regulatory submissions.

Supplier implication

• Even when competition appears, supplier risk remains:
  • qualification timelines,
  • viral/batch consistency controls,
  • and cold-chain logistics for live attenuated products.

Key Takeaways

• Public “supplier” identification for SKLICE is strongest at the site level through FDA labeling manufacturing disclosures, not full tier-1 raw-material vendor lists.
• For commercial sourcing, the defensible path is:
  • extract label-disclosed manufacturer sites and names,
  • then map those sites to inspection and regulatory documentation.
• Upstream vendors for excipients and raw materials are typically not fully published; identification usually requires DMF or submission-level detail not present in standard public label text.

FAQs

1. Who is the marketing authorization holder for SKLICE and how does that affect supplier discovery?
2. Which manufacturing sites are named on SKLICE labeling for bulk manufacture and packaging?
3. How do DMFs typically reveal excipient suppliers for live attenuated vaccines like SKLICE?
4. What qualification and quality barriers limit alternative CMOs for live attenuated virus fill-finish?
5. What competitive pathways exist for SKLICE that influence future supply chain design?

References

1. U.S. Food and Drug Administration. SKLICE (varicella virus vaccine) prescribing information and labeling (accessed 2026-05-24).