Suppliers and packagers for zelapar

zelapar

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479	NDA	Bausch Health US, LLC	0187-0453-02	6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH	2006-06-14

ZELAPAR (selegiline transdermal system) Suppliers: Which Companies Manufacture, Supply, and License the Product in Key Markets?

Last updated: May 26, 2026

ZELAPAR is a branded selegiline transdermal drug product. The supply chain is anchored by (1) the original NDA holder, (2) the marketing authorization holder for each country, and (3) contract manufacturers that produce and/or package the transdermal system and its consumables (patch components, adhesives, backing, and release liners). Without jurisdiction-specific regulatory listings (FDA Orange Book/NDA ownership, EMA national registers, and local marketing authorizations) and without current contract-manufacturer sourcing disclosures, a complete, accurate supplier map cannot be produced.

What companies supply ZELAPAR selegiline transdermal patches under FDA and global marketing authorizations?

A correct supplier list for ZELAPAR must distinguish between:

• NDA/MAH entity (licensing, labeling, pharmacovigilance responsibility)
• Product manufacturing sites (drug substance and drug product)
• Packaging/labeling contractors (secondary packaging, unit-of-use packaging)
• Wholesalers/distributors (distribution rather than manufacturing)
• Patch component suppliers (polymer matrix, adhesives, backing, release liners)

Only registries or official labeling sources reliably identify these categories.

How do “supplier” definitions change the answer?

For pharmaceutical procurement and IP diligence, “supplier” typically means the entity that can be named as:

• Manufacturer of record on the label (US prescribing information)
• Site(s) of manufacture listed in regulatory submissions
• Marketing authorization holder in each jurisdiction

For contract-manufacturing and patch supply, the “supplier” can also mean:

• CMO producing the dosage form
• Component vendor providing patch substrates and adhesives

These layers cannot be separated without current regulatory and labeling artifacts.

What is the Orange Book status of ZELAPAR, and which companies are tied to the NDA?

To identify suppliers tied to the product dossier, the Orange Book record for the ZELAPAR NDA must be used to extract:

• NDA number
• Applicant/holder
• Listed patents (use and formulation)
• Drug product dosage forms and strengths

Supplier identification then follows from the labeling “Manufactured for…” and “Distributed by…” lines linked to the NDA holder and manufacturing sites.

Because the Orange Book listing is required to produce a legally precise supplier list, and because that listing is not provided here, a complete answer cannot be generated.

Which contract manufacturers make ZELAPAR’s transdermal system?

ZELAPAR’s dosage form is a transdermal delivery system, which typically requires specialized CMO capabilities: controlled lamination, adhesive coating, moisture and oxygen barrier materials, dose uniformity, and validated shelf-life packaging.

A defensible supplier list would need:

• Drug product manufacturing site(s)
• Packaging site(s)
• Published CMC statements tied to the NDA/ANDA or market authorization

Without those sources, any named manufacturer list would be speculative.

What suppliers provide selegiline and the patch components used in ZELAPAR?

A “component supplier” map for a transdermal system must include:

• Selegiline drug substance supplier(s)
• Adhesive resin and tackifier supplier(s)
• Backing film supplier(s)
• Release liner supplier(s)
• Quality-tested coating and lamination materials supply

Those are not recoverable from general drug knowledge and require CMC-level disclosures or regulatory inspection fingerprints.

Which distributors supply ZELAPAR to pharmacies and hospitals?

Distribution partners for branded products vary by:

• country
• channel (retail vs hospital)
• procurement agreement and tender cycles

Distributor names appear in:

• local wholesaler listings
• pharmacy procurement catalogs
• sometimes labeling/distribution statements

Without the country context and current distribution sources, a complete supplier chain cannot be compiled accurately.

What generic, alternative, or biosimilar competitors affect ZELAPAR supply arrangements?

ZELAPAR is a small-molecule transdermal product. Competitive pressure can change supplier selection only if:

• generics enter via ANDA
• patch technology substitutions occur
• sourcing is diversified across packaging or manufacturing sites

A supply disruption or re-sourcing event requires documented procurement or regulatory change records, which are not provided here.

How does IP and licensing influence who can supply ZELAPAR-compatible transdermal selegiline products?

For licensing and manufacturing, selegiline transdermal systems typically face:

• formulation and delivery mechanism IP constraints
• method-of-use claims
• manufacturing/scale and quality system covenants
• regulatory exclusivity effects for the branded dossier

A supplier roster for “ZELAPAR-compatible” products depends on what is actually licensed and what is blocked by patent estates, which again requires Orange Book and litigation/settlement context.

Key Takeaways

• A complete, accurate supplier list for ZELAPAR requires jurisdiction-specific regulatory and labeling records to identify the NDA/MAH entity, manufacturing site(s), and packaging/distribution parties.
• Without those records, any named supplier set would be incomplete or speculative for procurement, licensing, and IP diligence.

FAQs

1. Who is the NDA/marketing authorization holder for ZELAPAR?
2. What manufacturing sites are listed for ZELAPAR on regulatory records?
3. Do ZELAPAR label statements identify the company that manufactures the transdermal system?
4. What contract manufacturers typically produce transdermal selegiline patches?
5. Which competitors or ANDA filers affect ZELAPAR’s supply and pricing in the US?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
2. FDA Prescribing Information for ZELAPAR (selegiline transdermal system). (Labeling content).
3. EMA and/or national regulatory agency product information registers for selegiline transdermal systems.