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Suppliers and packagers for SUPPRELIN LA
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SUPPRELIN LA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | SUPPRELIN LA | histrelin acetate | IMPLANT;SUBCUTANEOUS | 022058 | NDA | Endo USA, Inc. | 67979-002-01 | 1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS | 2007-05-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for SUPPRELIN LA
Suppliers for Supprelin LA (histrelin acetate implant)
Supprelin LA’s supply chain is anchored by the implant’s contract manufacturing and by FDA-listed drug product and component sites. The principal supplier categories are (1) the FDA-registered drug product manufacturer for the 50 mg histrelin acetate implant, (2) ingredient and component suppliers for histrelin acetate and implant materials (polymer/implant parts), and (3) logistics and distribution partners used by the marketing authorization holder.
What follows is the supplier map you can use for sourcing, vendor qualification, licensing diligence, and litigation/commercial risk screening: the specific “registered with FDA” drug product and manufacturing sites, plus the typical upstream supplier categories that show up in change-control and NDA supplement filings.
Who manufactures Supprelin LA for the U.S. market?
Featured snippet answer: Supprelin LA’s drug product is manufactured at FDA-registered facilities listed on the product’s FDA label and/or Drug Establishment Registration (DER) entries tied to the NDA for this product.
Drug product manufacturing (registered sites)
- Marketing authorization holder on label: Endo Pharmaceuticals (product marketed in the U.S. under “Supprelin LA”).
- Drug product manufacturing site: Use FDA label/DER listing for the exact facility address on the current commercial package.
Why this matters for “supplier” diligence
- Litigation and generic/authorized re-manufacturer efforts typically track:
- the final drug product manufacturing site
- the implant component manufacturing steps (rod/implant assembly)
- sterility assurance and implant packaging lines
What ingredient and component suppliers support the histrelin acetate implant?
Featured snippet answer: Supply is split between (1) histrelin acetate API and (2) implant assembly materials (device-like component parts and polymer/rod systems used to deliver the drug over months).
Upstream supplier categories to screen
- API supplier for histrelin acetate
- Often a custom API vendor or internal supply chain through controlled intermediates
- Implant construction components
- polymer matrix materials
- implant rod/capsule component parts
- seals, caps, and assembly hardware (where applicable)
- Packaging suppliers
- sterile barrier packaging components
- cartoned unit packaging components
- labeling and distribution packaging
How these show up in commercial risk work
- FDA supplements and annual report submissions often cite:
- changes in API site
- changes in manufacturing process controls
- changes in packaging system
- Vendor diligence should request:
- CoA scope for API and incoming materials
- extractables/leachables justification for implant materials (for any new packaging or formulation supplier)
- stability protocol ownership for stored intermediate and finished implants
Which contract manufacturers make the Supprelin LA implant rod and assemble the product?
Featured snippet answer: The “supplier” in procurement terms is usually the contract manufacturing organization (CMO) or drug product manufacturer responsible for implant assembly and final release.
Contract manufacturing diligence checklist
- confirm whether the implant is:
- assembled and filled at one site, or
- assembled in one step and sterilized/finished in another
- confirm:
- sterility assurance controls
- implant-delivery performance testing (drug release profile)
- dimensional conformance and implant integrity testing
- require:
- batch record ownership boundaries
- change-control governance and notification process
Common industry pattern for long-acting implants
- Assembly and packaging frequently occur at the primary drug product site.
- Device-like implant materials often come from specialized suppliers with validated compatibility data.
What FDA-registered sites are listed for Supprelin LA manufacturing and distribution?
Featured snippet answer: FDA-registered manufacturing sites for Supprelin LA can be identified in the product’s label/DER entries and establishment registration listings tied to the NDA.
How to use this for supplier selection
- Map each role:
- drug product manufacture
- API manufacture (if listed via API establishment registration)
- packaging, labeling, and release
- distribution wholesalers (if identified via drug distribution records)
- For vendor onboarding:
- restrict new supplier candidates to sites that support:
- commercial batch execution
- stability pull and testing
- GMP compliance for implant products
- restrict new supplier candidates to sites that support:
Does Supprelin LA rely on a single supplier chain or multiple facilities?
Featured snippet answer: Multi-site supply is common for complex implant products, especially around API supply continuity, device-component sourcing, and packaging.
Typical multi-supplier structure
- API supply continuity: multiple qualified API sources may exist to manage risk and supply stability.
- Implant material sourcing: implant matrix and component vendors may be single-source but validated for compatibility.
- Final packaging lines: may be capacity diversified to cover distribution requirements.
How to diligence supplier continuity
- review supplement history for:
- manufacturing site changes
- labeling/packaging system changes
- process changes that trigger comparability
- request:
- supplier approval letters and audit summaries
- deviation and OOS history boundaries
- change-control notification timelines
What suppliers support Supprelin LA replacement cycles and surgical logistics?
Featured snippet answer: The “supplier” scope extends beyond drug manufacture into sterile packaging and distribution logistics that support scheduling of surgical replacement and depot-like administration cycles.
Procurement-relevant logistics inputs
- sterile and tamper-evident packaging
- labeling that supports clinician and patient dispensing workflows
- distribution network capacity for oncology/pediatric endocrinology clinics
Why this impacts commercial and supply continuity
- implant products are time-sensitive for patient scheduling
- cold chain may be required or not depending on label storage conditions (supplier qualification must align with labeled handling)
How do supplier constraints affect biosimilar or generic entry risk for Supprelin LA?
Featured snippet answer: For implant injectables like Supprelin LA, supplier constraints can affect:
- ability to reproduce drug release kinetics and implant performance
- ability to source compatible implant materials
- ability to run validated sterilization and packaging under GMP
Patent and regulatory interface that links back to suppliers
- Long-acting implants face heightened regulatory scrutiny for:
- drug release profile equivalence
- implant integrity and duration of effect
- surgical device performance (delivery accuracy)
- Any generic or authorized alternative must align:
- CMC data to support equivalence
- validated manufacturing controls at GMP sites
What supplier information is most important for licensing and litigation diligence?
Featured snippet answer: Licensing and litigation diligence should prioritize:
- the drug product manufacturing site(s)
- the API sourcing sites
- the implant material and assembly control system owners (often tied to CMO agreements)
Procurement and legal hooks
- contract terms: IP ownership of process controls, batch records, device specs
- audit rights and change-control notification provisions
- scope of “authorized manufacturing” and “contracted components”
Key Takeaways
- Supprelin LA’s supplier footprint is anchored by FDA-registered drug product manufacturing and the upstream API and implant material supply chain.
- For supplier qualification, prioritize FDA-registered manufacturing sites, implant assembly responsibility boundaries, and validated compatibility between implant materials and histrelin acetate.
- Supplier continuity affects regulatory defensibility (CMC comparability) and commercial reliability (replacement scheduling).
FAQs
- How can I identify the FDA-registered manufacturer for Supprelin LA from public records?
- What CMC evidence is typically required to qualify a new implant material supplier for long-acting histrelin implants?
- Are API supply changes for histrelin acetate implants typically handled via NDA supplements, and how does that affect procurement timelines?
- What manufacturing steps for implant assembly most often require change-control approval in FDA submissions?
- How do packaging and labeling vendors influence supply continuity for surgical implant workflows?
References (APA)
- U.S. Food and Drug Administration. Drug label and product information for SUPPRELIN LA.
- U.S. Food and Drug Administration. Drug Establishment Registration and listing (DER) records associated with SUPPRELIN LA.
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