Suppliers and packagers for xulane

xulane

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910	ANDA	Mylan Pharmaceuticals Inc.	0378-3340-53	3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH	2014-04-16
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910	ANDA	A-S Medication Solutions	50090-1683-0	3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCH	2014-04-16

Suppliers and packagers for xulane

Last updated: May 26, 2026

XULANE (ethinyl estradiol / norelgestromin) suppliers: Who manufactures the patch and what companies supply active ingredients?

Xulane is a contraceptive transdermal system (patch) delivering ethinyl estradiol (EE) and norelgestromin. In the US, the product is marketed by Organon and supplied/manufactured through Organon’s branded supply chain (with potential contract manufacturing for finished dosage form and component inputs). Publicly accessible, transaction-grade supply chain visibility for every step (API, intermediates, patch-film layers, adhesive, pouching, and secondary packaging) is limited in open sources.

Who is the manufacturer and distributor of XULANE in the US?

Commercial label and marketing entity

• Xulane (ethinyl estradiol and norelgestromin) transdermal system
• Label/marketing company (US): Organon (brand owner and NDA holder for the marketed product)

Typical supply-chain structure for a transdermal contraceptive

• Finished dosage form (patch) manufacture is usually done by a dedicated sterile-equivalent, controlled-adhesive manufacturing line (adhesive coating, backing/liner lamination, die-cutting/patch forming, packaging).
• API sourcing is generally split into:
  • EE API supply
  • norelgestromin API supply
  • Polymer/adhesive system inputs (pressure-sensitive adhesive, tackifier resins)
  • Patch backing and release liner materials

What active pharmaceutical ingredients (APIs) does XULANE use and who supplies them?

Xulane contains:

• Ethinyl estradiol (EE)
• Norelgestromin (NGMN)

Open regulatory databases (FDA drug labeling text and public records) usually do not provide a complete, current list of every API supplier for a specific NDA product. Supplier identities can change across campaigns, and API supply can be multi-sourced without a single canonical “supplier of record” in public label text.

What contract manufacturers supply XULANE transdermal patches?

Finished-dose manufacturers for transdermal systems are often contract partners or internal Organon sites, depending on market demand and technology transfer. Publicly listed information that definitively names contract manufacturers for Xulane is not consistently published outside:

• FDA facility registration details tied to manufacturing types (not always mapping cleanly to a specific product in public views)
• procurement or corporate reports
• litigation and CMO capacity documents
• EudraGMP and inspection reports (not always product-specific in a way that yields a definitive “Xulane CMO list”)

Because of this, a complete “supplier list” for patch manufacture for Xulane cannot be stated with the level of precision required for actionable sourcing decisions from open sources alone.

How do you identify XULANE manufacturing sites using FDA data?

For operational diligence, the usual approach is to reconcile:

1. FDA facility registrations (manufacturing, testing, packaging categories)
2. Product-specific labeling and submission history (when available in public dockets)
3. Inspection outcome records tied to establishments
4. Batch record linkage where disclosed in non-public or litigation materials

This can be performed deterministically for manufacturing capability mapping, but it does not always produce a one-to-one mapping from “facility” to “Xulane lot supplier” without deeper docket-level evidence.

What suppliers provide the patch’s delivery components (adhesive, backing, liner)?

For transdermal delivery systems, component suppliers typically fall into these technical buckets:

• Pressure-sensitive adhesive system precursors (PSA-grade polymers, tackifiers, plasticizers)
• Backing film and release liner materials
• Coating/printing inks and protective overwraps
• Packaging (pouching, foil laminate, secondary cartons)

Public supplier names for these inputs are typically not published in FDA label text and are often not exposed unless:

• a specific component supplier is named in regulatory submissions that become public
• a CMO supply chain is identified via litigation filings
• procurement disclosures exist in corporate statements

A definitive component-supplier list for Xulane cannot be provided from open regulatory labeling material alone.

What patent estate factors matter for sourcing and substitution of XULANE?

Supplier changes for transdermal systems are frequently constrained by:

• formulation and manufacturing method IP
• process know-how (adhesive composition, coating parameters, stabilization, multilayer construction)
• device-specific release-rate performance targets

Xulane is an established branded contraceptive patch, and supply substitutions must avoid infringing:

• formulation claims (EE/NGMN in specific adhesive matrices)
• methods of manufacture
• use claims related to dosing and regimen

This affects who can safely qualify as a substitute manufacturing partner and what tech transfer package is required for scale.

When do generic or AB-substitute versions change supplier risk for XULANE?

For sourcing continuity, the relevant question is whether an AB-rated product or authorized generic reduces branded demand and thereby changes:

• CMO utilization rates
• packaging supply obligations
• procurement allocations for adhesives and patch film

However, mapping that to “Xulane suppliers” still requires up-to-date market supply chain intelligence tied to manufacturing registrations and contract capacity.

Key Takeaways

• Xulane is marketed in the US by Organon for a transdermal contraceptive delivering ethinyl estradiol and norelgestromin.
• Open public sources generally do not provide a complete, current list of:
  • API suppliers for EE and norelgestromin
  • contract patch manufacturers (CMOs)
  • component suppliers for adhesive systems and patch film/liner
• A defensible sourcing map requires reconciliation of FDA facility registration and submission/inspection records, plus docket-level evidence when available.

FAQs

1. What is the active ingredient combination in Xulane?
   Xulane contains ethinyl estradiol (EE) and norelgestromin (NGMN).

2. Who holds the Xulane NDA and markets the product in the US?
   Organon.

3. Can FDA label text name the contract manufacturer for Xulane patches?
   Often it does not in a way that yields a definitive contract-manufacturer list.

4. How do you find Xulane manufacturing sites in FDA databases?
   Use FDA establishment registrations by manufacturing/packaging/testing category and reconcile with product mapping in submissions and inspection records.

5. What supply-chain components matter most for transdermal contraceptive patches?
   Adhesive system precursors, backing and release liner materials, and patch lamination/coating and packaging components.

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References (APA)

1. FDA. (n.d.). Drug label: Xulane (ethinyl estradiol and norelgestromin) transdermal system. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA: Xulane. U.S. Food and Drug Administration.