GOSERELIN ACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Goserelin Acetate Suppliers: Who Makes It, Who Ships It, and What to Screen in Procurement

Goserelin acetate active pharmaceutical ingredient (API) and finished-dose supply typically come from a small set of dedicated peptide manufacturing networks and contract manufacturers that support depot formulations (most commonly 3.6 mg and 10.8 mg). Supplier selection for goserelin acetate should be driven by (1) whether the vendor supplies peptide API vs depot kit components, (2) quality system maturity for sterile depot manufacturing, and (3) regulatory track record (FDA DMF/biocompatibility packages, if applicable).

Critical procurement note: “Goserelin acetate suppliers” splits into two sourcing models: (a) API/peptide suppliers (raw material supply), and (b) injectable depot kit suppliers (sterile long-acting formulation with the polymer matrix and implant delivery hardware). In practice, most manufacturer-to-manufacturer availability is constrained by peptide capacity, impurity control for long-acting depots, and regulatory dossier ownership.

Below is the actionable supplier map you can use for procurement screening based on market-standard supplier categories for goserelin acetate depot products.

Which companies supply goserelin acetate API vs depot kits?

Featured snippet answer: The market supply chain for goserelin acetate is dominated by (1) peptide/API producers for GnRH analogs and (2) sterile depot formulation and filling partners that package the implant-ready system for submission under NDA/ANDA/505(b)(2) dossiers.

API suppliers (goserelin acetate active)

Common sourcing routes:

Peptide synthesis specialists that can support complex GnRH analogs and control deamidation, oxidation, and truncation impurities.
Fermentation-to-peptide platform companies that own peptide intermediates and can provide batch-level impurity profiles aligned to depot specification.

Procurement screening criteria for API:

DMF availability (Type II) or referenced dossier support
Impurity release strategy aligned to long-acting implant acceptance criteria
Ability to supply consistent particle size and water content targets (if the API is shipped into kit formulation workflows)
Long-acting depot impurity sensitivity and stability data

Depot kit and finished product suppliers (sterile long-acting implant)

Depot goserelin acetate products typically require:

Polymer matrix (biodegradable implant forming step)
Sterile manufacturing under controlled aseptic conditions
Prefilled delivery system compatibility with the implant geometry

Procurement screening criteria for depot kits:

Sterile aseptic capability and batch record governance
Compatibility between implant polymer grade and goserelin acetate peptide quality
Extractables/leachables and device-implant integration documentation
Stability indicating analytical method transfer readiness

What suppliers provide goserelin acetate 3.6 mg depot vs 10.8 mg depot?

Featured snippet answer: The supplier base often overlaps at API level but diverges at the sterile depot manufacturing and kit assembly level because the implant geometry and polymer-to-drug ratio differ between 3.6 mg monthly and 10.8 mg every-12-weeks regimens.

3.6 mg (monthly) sourcing patterns

More manufacturing partners can support monthly depot lines because process footprint is established for legacy submissions and broader capacity demand.

10.8 mg (every-12-weeks) sourcing patterns

Fewer qualified vendors due to additional implant validation, device integration, and dossier-specific comparability requirements for long interval release.

How to identify goserelin acetate suppliers through regulatory filings (Orange Book and DMFs)?

Featured snippet answer: Use FDA dossier ownership and listing evidence to distinguish true API suppliers from finished product labelers and to confirm whether a supplier’s material is referenced in approved applications.

Procurement workflow:

Start with FDA application holders for the labeled goserelin acetate products (NDA/ANDA).
Retrieve facility and manufacturing site data from FDA labels and application manufacturing descriptions.
Where available, map to DMF reference pathways (Type II API DMFs or supplier-referenced modules).
Match vendor names to:
- manufacturing site listings
- API manufacturing statements
- kit assembly and sterile filling steps
- change control histories

This avoids a common failure mode where vendors market “goserelin acetate” but only supply non-aligned intermediates or non-validated grades.

What is the supplier landscape for generic goserelin acetate implants?

Featured snippet answer: Generic or 505(b)(2) goserelin acetate availability depends on (a) access to a qualified API and (b) a depot manufacturing line that can reproduce release characteristics and stability.

Generic supplier screening:

Verify whether the ANDA uses a supplier-referenced API or a fully owned peptide process
Confirm whether kit components are sourced from:
- a qualified polymer supplier network
- a sterile assembly partner
- a device/implant integration vendor
Evaluate likely quality agreement maturity: goserelin acetate is peptide-sensitive and long-acting depots are impurity-profile sensitive.

Which companies are approved manufacturers or label holders for goserelin acetate products?

Featured snippet answer: Label holders and approved manufacturers are identified through FDA product labeling and listing records for goserelin acetate depot products (3.6 mg and 10.8 mg).

From a procurement standpoint, two layers matter:

NDA/ANDA holder (commercial and regulatory owner)
cGMP manufacturing site (where sterile depot assembly and release testing occurs)

Supplier selection should prioritize:

direct contract manufacturing by the regulatory holder or
qualified CMOs with a demonstrated regulatory history for sterile depot drug products

What manufacturing risks affect goserelin acetate supplier qualification?

Featured snippet answer: The main supplier qualification risks are peptide impurity control, sterile depot assembly reproducibility, and device-implant performance variability.

Quality risks specific to goserelin acetate peptides

Oxidation and deamidation pathways that change impurity distributions over time
Truncation impurities from peptide synthesis
Lot-to-lot variability that impacts depot release profile

Depot assembly risks

Polymer grade variability affecting drug release rate
Sterile assembly process deviations leading to unacceptable bioburden or particulate risk
Device-implant geometry issues impacting administration performance

How many suppliers can realistically support goserelin acetate long-acting depot projects?

Featured snippet answer: The effective supplier count is typically small because the supply must cover both peptide-grade quality and sterile depot formulation capabilities.

A practical supplier universe for depot projects is constrained by:

peptide synthesis capacity for GnRH analogs
sterile depot kit manufacturing lines
regulatory track record for long-acting injectables

What patent/IP barriers impact supplier entry for goserelin acetate?

Featured snippet answer: For widely marketed goserelin acetate depots, supplier barriers are often more about formulation know-how, process validation, and regulatory dossier referencing than active primary compound patents, because peptide drug substance patents and early formulation patents are typically mature or expired.

Supplier due diligence:

Verify whether any formulation-specific patents still cover the depot matrix, implant composition, or manufacturing method.
Screen whether the planned launch route relies on Paragraph IV for formulation claims or instead uses literature/data bridging for 505(b)(2) or ANDA referencing.

(Your actual freedom-to-operate depends on the jurisdiction and the specific product configuration: 3.6 mg vs 10.8 mg, plus implant/device system.)

Supplier commercialization: who can supply at scale and at what lead times?

Featured snippet answer: Scale supply typically belongs to suppliers with validated sterile depot capacity and established release testing frameworks. API-only suppliers can be scale-limited by peptide synthesis campaigns and impurity specification requirements.

Procurement levers:

long-term supply agreement for peptide campaign reservation
validated change control clauses for impurity profile movement
inventory buffer strategy for depot implant geometry and polymer lot availability

Key Takeaways

Goserelin acetate supply splits into API peptide suppliers and sterile depot kit/finished product manufacturers; depot manufacturing qualification is the gating factor for most procurement decisions.
Supplier screening should prioritize regulatory evidence (manufacturing site listings and dossier linkage), peptide impurity control capability, and sterile depot assembly reproducibility.
Effective supplier count for long-acting depots is small because sterile implant manufacturing, device integration, and release-profile comparability constrain entry more than raw API availability.
For generic or lifecycle projects, dossier strategy (API source and comparability package) is as important as procurement price and availability.

FAQs

1) Who supplies goserelin acetate for depot injections (3.6 mg and 10.8 mg)?
Depot supply is typically provided by sterile depot manufacturers and kit/implant assembly partners, with API usually sourced from peptide specialists through qualified supply agreements.

2) What should a contract manufacturer demonstrate to qualify as a goserelin acetate depot supplier?
Sterile depot manufacturing cGMP capability, validated implant assembly process, impurity-sensitive release characterization, and dossier-aligned stability/analytical methods transfer.

3) What are the main quality specs to audit in goserelin acetate API procurement?
Impurity profile (oxidation/deamidation/truncation), residual solvents, water content/physical attributes tied to depot formulation behavior, and batch traceability.

4) How do lead times typically differ between goserelin acetate API and finished depot kits?
API lead times are driven by peptide campaign capacity, while depot lead times are driven by sterile aseptic scheduling, device/implant assembly, and release testing.

5) What is the most common failure mode when onboarding a new goserelin acetate supplier?
Inability to match depot release and impurity acceptance criteria due to peptide impurity drift or depot matrix/process variability.

References (APA)

U.S. Food and Drug Administration. (n.d.). Drug product labeling and application information for goserelin acetate depot products. FDA. https://www.fda.gov
U.S. Food and Drug Administration. (n.d.). Drugs@FDA. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

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