LEUPROLIDE ACETATE FOR DEPOT SUSPENSION: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Invagen Pharms	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054	NDA	CIPLA USA INC.	69097-909-50	1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31)	2022-07-15
Invagen Pharms	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054	NDA	Avyxa Pharma, LLC	83831-134-01	1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)	2025-03-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

Suppliers for Leuprolide Acetate for Depot Suspension: Active Ingredient, Depot Formulation, and Contract Manufacturing Options

Leuprolide acetate for depot suspension is supplied through a chain split between (1) leuprolide acetate API manufacture, (2) depot-suspension formulation and fill-finish, and (3) distribution under brand-labeled NDCs. Supplier identification is NDC-specific and route-of-administration specific because depot suspensions rely on sterile manufacturing, controlled particle-size suspension specs, and validated reconstitution/administration workflows.

Which companies supply leuprolide acetate API for depot suspensions?

Leuprolide acetate API sourcing typically sits with large peptide API manufacturers that also support long peptide stability and impurity control. In practice, branded depot products are supplied via (a) direct API-plus formulation supply agreements or (b) API-to-formulator licensing where the formulator holds the depot product platform.

API supply patterns in depot peptide products

API is produced under GMP with in-process controls targeted to peptide integrity and impurities tied to cleavage/oxidation.
Depot suspensions require strict control of particle size distribution in the final suspension, which constrains API lot-to-lot variability.
Supply chains often include dual sourcing for continuity due to batch-to-batch yield variability in peptide manufacturing.

Who manufactures leuprolide acetate for depot suspension (formulation + sterile fill-finish)?

Depot suspension manufacturers are usually contract manufacturers with capabilities for:

sterile injectable suspension processing
lyophilized-to-suspension or direct suspension manufacturing depending on the product presentation
long-term stability for depot particle settling and suspension re-dispersibility
closed manufacturing lines to reduce particulate and microbial risk

Common depot suspension manufacturing steps

API and excipients blending or wet-milling to achieve a target particle-size distribution
sterile filtration or aseptic processing strategy depending on validated process
filling into dual-chamber or prefilled formats (product presentation driven)
packaging aligned with administration technique (reconstitution, injection preparation, storage conditions)

What are the major supplier models for leuprolide acetate depot suspensions?

Supplier structures for depot products usually fall into three commercially common models:

Brand principal with vertically integrated manufacturing
- Brand owner holds the dossier and manufacturing approvals.
- Supply is performed by the brand owner’s network plants or directly managed CDMOs.
API manufacturer supplies through a formulator/CDMO
- API supplier sells API to a formulator who owns the depot formulation process and final fill-finish.
- Often includes technical transfer and quality agreements.
License-and-manufacture under product platform
- Brand owner licenses a depot platform to a CDMO.
- The CDMO performs formulation and fill-finish under the brand holder’s control.

How do you identify the correct suppliers for a specific leuprolide acetate depot NDC?

Supplier identification for this product class is best done by mapping:

the specific NDC (concentration, pack size, syringe vs vial format)
the labeler and manufacturer listed on the FDA label
the FDA establishment IDs linked to manufacturing and testing
the Orange Book listing tied to the product and strength

Depot suspensions are not one-size-fits-all, so the same active ingredient can route through different manufacturing sites across strengths and label configurations.

Orange Book and FDA label mapping

Orange Book lists the drug product and patent/ exclusivity hooks for that labeled product.
FDA label lists the manufacturing information and responsible parties for each presentation.
FDA establishment listings map to actual sites for manufacturing/testing.

What patents and exclusivity do supplier networks have to respect for leuprolide acetate depot suspension?

Even if the question is supplier-centric, manufacturing eligibility is constrained by:

Orange Book-listed patents for the specific depot product
any granted exclusivity (new chemical entity, new therapeutic, orphan, or formulation-specific exclusivity)
patent-protected manufacturing and formulation characteristics that may block generic entry or require design-around

Supplier risk drivers tied to exclusivity and patents

if the depot suspension is protected by a formulation or method-of-use patent, CDMOs can face transfer limits and quality-only manufacturing constraints
if there is a pending ANDA with Paragraph IV certifications for the same NDC strength/presentation, supplier readiness can be affected by settlement terms

How many suppliers exist globally for leuprolide acetate depot suspensions?

The global supplier pool is limited by:

sterile depot suspension manufacturing capacity
peptide API scale-up and impurity specification requirements
regulatory experience with depot injection products and stability constraints

As a result, supplier competition is concentrated among a small set of vertically integrated peptide or injectable depot specialists and a narrower set of CDMOs that handle complex sterile suspensions.

Which suppliers have the manufacturing capability for depot suspension particle-size control?

Depot suspension performance is tied to particle-size distribution and re-suspension characteristics. Suppliers with the most fit-for-purpose capability generally have:

validated milling or dispersion processes
in-line or validated characterization for size distribution
robust stability programs for settling and re-dispersibility
sterile fill-finish platforms for injectable suspensions

For peptide depot injectables, this capability is a stronger differentiator than general sterile injection manufacturing.

What does “contract manufacturing” look like for leuprolide acetate depot products?

Contract manufacturing typically divides as:

API supply: peptide API producer under GMP
Formulation: depot formulation and sterile suspension manufacturing
Fill-finish: aseptic filling, labeling, packaging, and distribution release testing
Quality oversight: batch record review, deviation handling, and release testing coordination with the NDA/ANDA holder

What generic entry risks exist for leuprolide acetate depot suspension that can affect supplier demand?

Generic demand risk is driven by:

patent barriers on the exact labeled formulation and dosage form
exclusivity timing and Paragraph IV litigation outcomes
settlement agreements that delay or limit supply-to-market

Supplier demand can swing when:

a settlement grants delayed launch with “authorized supply” arrangements
an ANDA receives approval but is bottlenecked by manufacturing readiness at the CDMO layer

How do leuprolide acetate depot suppliers compare with suppliers for other GnRH agonist depots?

Compared with other GnRH agonist depots (e.g., triptorelin or goserelin depots), leuprolide acetate depot supplier selection is constrained by peptide-specific manufacturing and depot suspension spec control. The competitive overlap is usually:

CDMOs capable of sterile depot injections across peptide chemistries
API suppliers capable of long-chain peptide synthesis and peptide purity control

Key takeaways for supplier selection and sourcing strategy

Treat supplier identification as NDC- and presentation-specific, not just active-ingredient specific.
Depot suspension CDMOs need validated control of particle size distribution and suspension re-dispersibility.
Supplier access and manufacturing timelines depend on Orange Book patents and exclusivity for the exact product listing, which can limit generic manufacturing or trigger authorized supply structures.
Supplier landscape is concentrated among peptide-capable API producers and depot-sterile fill-finish CDMOs with proven regulatory and stability programs.

FAQs

How do I determine the contract manufacturing site for a specific leuprolide acetate depot NDC?
What quality attributes most influence depot suspension performance for leuprolide acetate?
Do different leuprolide acetate depot strengths use the same manufacturer and fill-finish sites?
How do Paragraph IV challenges affect supplier capacity planning for depot injectables?
What manufacturing changes typically require comparability studies in leuprolide depot suspension?

References

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
U.S. Food and Drug Administration. Drug Labels (DailyMed). (Database).
U.S. Food and Drug Administration. Drugs@FDA. (Database).

Suppliers and packagers for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION