Suppliers and packagers for zoladex

zoladex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726	NDA	TerSera Therapeutics LLC	70720-950-36	1 POUCH in 1 CARTON (70720-950-36) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE	2018-03-31
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578	NDA	TerSera Therapeutics LLC	70720-951-30	1 POUCH in 1 CARTON (70720-951-30) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE	2018-01-26

ZOLADEX (goserelin) suppliers: key manufacturers of finished drug products, authorized generics, and regulated supply chain touchpoints

Last updated: May 25, 2026

Zoladex (goserelin) is supplied through a multi-layer chain: (1) active pharmaceutical ingredient (API) suppliers for goserelin acetate, (2) finished-dose manufacturers of the implant (typically the 3.6 mg and 10.8 mg strengths), (3) packaging and distribution partners, and (4) regional marketing authorization holders and wholesalers. The supplier landscape is determined by the applicable reference product ownership and by which parties hold marketing authorization and manufacture under license for each country market.

What companies supply Zoladex (goserelin) implants in 3.6 mg and 10.8 mg?

Zoladex is an LHRH (GnRH) agonist delivered as a subcutaneous depot implant. Supply is anchored by the original product authorization holder in each territory and by contract manufacturers producing the implant body and performing the final drug product fill-and-finish.

Finished product manufacturers: which firms make the implant dosage form?

Core supplier categories for Zoladex implants:

• Implant manufacturing (formulation, sterile implant preparation, and depot assembly)
• Sterile manufacturing controls and aseptic/bioburden processes as applicable to implant production lines
• Final packaging (unit-dose implant packaging) and cold-chain or temperature-controlled handling where required by local regulations

API suppliers: who makes goserelin acetate?

Goserelin acetate API is a specialized peptide-like small-molecule (synthetic) that typically comes from a limited set of global fine-chemical and API producers. The practical “supplier list” for Zoladex in a given market is the set of API vendors used by the implant manufacturer and cleared under regulatory filings and quality agreements.

Which vendors provide goserelin acetate API for Zoladex supply chains?

Goserelin acetate suppliers vary by region and by the approved supplier network in the drug master files and manufacturing sites referenced in regulatory submissions. For decision-making on sourcing risk, target:

• Approved API manufacturing sites listed in regulatory dossiers for each Zoladex strength
• Quality agreements (GMP release, change control, and supplier replacement provisions)
• Inspection record history for the API site(s)

What is the Orange Book status of Zoladex, and how does it map to supplier availability?

Zoladex is marketed in multiple strengths and geographies. In the U.S., the relevant “supplier visibility” in practice comes from:

• FDA “Orange Book” listings for the reference product and any approved generic equivalents (if any)
• Section viii listing of patent-to-drug linkages that drive which manufacturers can enter

Does U.S. exclusivity affect who can supply Zoladex?

Yes. Patent and exclusivity status influence whether additional FDA-approved manufacturers can ship a generic/authorized equivalent into the U.S. market, and they influence the practical number of active suppliers.

When does Zoladex lose exclusivity, and what does that mean for sourcing?

Exclusivity loss affects:

• The number of competitively sourced finished-dose suppliers
• Pricing dynamics and contracting leverage
• Availability of alternate manufacturing sites and API procurement flexibility

Timing differs by jurisdiction and depends on strength (3.6 mg vs 10.8 mg), route, and dosage form, as well as whether there are separate patent estates for each strength and related formulations.

What generic entry risks exist for Zoladex that could change supplier base?

Generic-entry risk affects the supply base in two ways:

1. New finished-dose generic approvals can add suppliers to distributor networks.
2. Paragraph IV and patent litigation (where applicable) can delay entry of new supply, consolidating purchasing power with incumbents.

For implant depot products like Zoladex, formulation and manufacturing method patents can constrain “drop-in” manufacturing substitution even when the core active ingredient is the same.

Which companies challenge Zoladex via Paragraph IV, and how does that affect supply?

Paragraph IV challenges and litigation are supply-shaping events. When challengers or intervening generic applicants seek approval during patent windows, they can:

• Freeze certain competitors out of the market
• Trigger settlement agreements that allocate launch timing
• Create temporary supply shortages if the incumbent’s manufacturing and distribution cannot absorb demand

What patent litigation affects Zoladex suppliers in the U.S. and EU?

For supplier diligence, litigation matters because it dictates:

• Whether a generic manufacturer can legally ship in each territory
• Whether contract manufacturing capacity can be redeployed to a Zoladex product line
• Whether there are forced supply agreements or risk-trigger clauses in drug distribution contracts

What formulations are protected for Zoladex implants, and does that constrain alternative suppliers?

Zoladex is an implant depot. Patent families can cover:

• The implant composition and release characteristics
• The manufacturing process and implant-specific geometry or structure
• Method-of-use indications (hormone-sensitive and prostate/cancer-related indications)

If formulation or process patents remain in force, alternative manufacturers may be limited to non-infringing designs, which reduces supplier interchangeability.

How do EU marketing authorization holders and packers influence the supplier list for Zoladex?

In EU markets, supply visibility is driven by:

• The marketing authorization holder (MAH) on the label for that country
• The manufacturing site(s listed on regulatory submissions and product labeling
• Local packers and distributors that control the “ready-for-sale” supply channel

This can yield different operational “suppliers” per country even when the same global manufacturer makes the implant.

Supplier due diligence checklist for Zoladex sourcing and procurement risk

For pharma procurement, the Zoladex supplier picture should be mapped as:

• API: approved API manufacturing sites used by the implant manufacturer(s)
• Drug product: approved finished-dose manufacturing sites for each strength
• Release: batch release testing site and quality unit
• Packaging: the packaging site for each market SKU
• Distribution: the authorized distributor network and any parallel trade constraints
• Regulatory: market-by-market MAH and labeling entities

Key Takeaways

• Zoladex supply is constrained by implant depot manufacturing complexity and by the approvals tied to specific manufacturing sites.
• The practical “supplier list” by market is defined by MAH and label-registered manufacturers, not by API suppliers alone.
• Patent and exclusivity status influences how quickly additional FDA- and EMA-regulated manufacturers can enter, shaping the number of active finished-dose suppliers.

FAQs

1. Who is the marketing authorization holder for Zoladex in the U.K., France, Germany, and Italy?
2. Which FDA listings (Orange Book) govern generic availability for Zoladex in the U.S.?
3. What contract manufacturing sites typically produce implant depot products like Zoladex, and how are they identified in regulatory documentation?
4. How do manufacturing site changes for goserelin acetate implants get managed under GMP change control?
5. What distributor networks supply Zoladex to hospitals and wholesalers, and how are allocations handled during shortages?

References

1. FDA Orange Book. U.S. Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
2. EMA. European public assessment reports and EPAR product information for Zoladex (goserelin).