Suppliers and packagers for SUBLOCADE

SUBLOCADE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819	NDA	Indivior Inc.	12496-0100-1	1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5)	2018-02-26
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819	NDA	Indivior Inc.	12496-0300-1	1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5)	2018-02-26

Suppliers and packagers for SUBLOCADE

Last updated: May 25, 2026

Sublocade suppliers: who manufactures and supplies the depot buprenorphine injection (NDC), and what supply/IP constraints matter?

Executive summary: Sublocade (buprenorphine extended-release injectable, for subcutaneous use) is supplied in the US by Braeburn Pharmaceuticals as the branded marketer, with manufacturing by Camber/Specialty or the original authorized manufacturer chain for the depot product. For inbound sourcing and contingency planning, the supply risk is driven less by active-pharmaceutical ingredient availability and more by sterile depot manufacturing, fill-finish, and the extended-release/formulation process, which typically restricts true second-source manufacturing.

Who is the supplier for Sublocade (braeburn) in the US supply chain?

Answer (featured snippet): In the US, Braeburn Pharmaceuticals is the branded supplier/marketer for Sublocade (buprenorphine extended-release injection). The product’s manufacturing is performed through approved sterile manufacturing sites that execute the depot/formulation and fill-finish under the NDA/CMC package.

What roles exist in the Sublocade supply chain?

1. Brand holder / NDA holder / marketer
   • Controls labeling, distribution agreements, and the US regulatory dossier.
2. Drug substance and drug product manufacturers
   • Drug substance supply and depot formulation manufacturing.
3. Sterile fill-finish and packaging sites
   • Critical path for injectable sterility assurance and depot manufacturing parameters.
4. Distribution wholesalers
   • US channel fulfillment and inventory logistics.

Where do distributors fit for Sublocade?

Sublocade reaches endpoints through authorized wholesalers and specialty distributors that manage cold-chain is not always required, but injectable handling and temperature controls are still enforced via label and supply SOPs.

Which companies manufacture Sublocade (where are the drug product and fill-finish done)?

Answer (featured snippet): Sublocade is manufactured at approved sterile injectable depot manufacturing and fill-finish sites under the NDA, with the approved manufacturers listed in FDA CMC and the label’s “Manufactured for” and “Manufactured by” lines.

How to map “manufacturer” vs “supplier” on labeling

• “Manufactured for” usually indicates the marketer relationship.
• “Manufactured by” or “Distributed by” indicates the site performing the manufacturing step(s).
• Depot injectables often list the firm(s) responsible for drug product manufacturing and packaging.

Why depot manufacturing limits second-source options

Extended-release buprenorphine depots require control of:

• particle morphology and dispersion,
• solvent system removal process,
• depot viscosity and syringeability,
• terminal sterilization or aseptic strategy (depending on the process),
• in-process controls that preserve release kinetics.

These create higher CMC and validation burdens than non-depot generics.

What NDCs and package strengths exist for Sublocade, and do supplier changes track by NDC?

Answer (featured snippet): Sublocade is marketed in distinct kit/strength configurations (commonly including initiation and monthly maintenance doses). In practice, supplier/manufacturer identifiers can vary by NDC if multiple fill-finish lines or contract sites are authorized.

Common supplier mapping by NDC

• Initiation and maintenance strengths can have different packaging lines.
• Each NDC can point to a specific configuration, lot, and authorized manufacturer site.

Are there approved alternative suppliers or contract manufacturers for Sublocade after manufacturing changes?

Answer (featured snippet): Contract manufacturing is typically controlled by NDA supplement approvals and approved CMC changes. When a manufacturer site changes, the FDA CMC package is updated and the label manufacturing statement reflects authorized sites.

What triggers a new supplier listing

• site transfers,
• line changes for fill-finish,
• process parameter updates that require comparability,
• additional capacity approvals.

What supply risks exist for Sublocade (shortages, allocation, and continuity of supply)?

Answer (featured snippet): Supply risk for depot buprenorphine products is usually tied to sterile depot capacity, validated aseptic/fill-finish line throughput, and lot release timelines, not raw API alone.

Where shortages tend to originate

• constrained sterile capacity,
• slow sterility assurance release,
• raw material lead times for excipients used in the depot matrix,
• regulatory hold or investigational deviation impacting lot release.

What patent/IP constraints affect supplier entry for Sublocade manufacturing?

Answer (featured snippet): Even when a firm can source API, depot manufacturing and formulation know-how can be constrained by proprietary extended-release composition and process patents, plus NDA exclusivity and Orange Book-listed patents if applicable to the product.

How IP interacts with sourcing decisions

• CMO contract acceptance may require freedom-to-operate coverage.
• Scale-up and process replication can require license or design-around if protected process claims exist.

How does Sublocade compare with Probuphine, Brixadi, and generics in supplier structure?

Answer (featured snippet): Other monthly/implant or injectable buprenorphine depots often use specialty formulation CMOs with less generic-style multi-vendor sourcing.

Competitive supply landscape

• Sublocade is a depot injectable with commercial-scale sterile fill-finish.
• Brixadi is another buprenorphine depot with its own manufacturing network.
• Probuphine (implant) relies on different delivery system and manufacturing steps.

Key Takeaways

• Braeburn Pharmaceuticals is the US branded supplier/marketer for Sublocade.
• The real supply bottleneck is sterile depot manufacturing and fill-finish, which limits true second-source capacity.
• If manufacturers change, NDC-specific label/manufacturer statements typically reflect which authorized sites execute depot manufacturing and packaging.
• IP and CMC constraints matter for any new entrant CMO or co-manufacturer seeking to supply the depot product.

FAQs

1. Is Sublocade manufactured in-house by Braeburn or by contract manufacturers?
2. Do Sublocade shortage events correlate with specific NDCs or manufacturing sites?
3. Can CMOs supply Sublocade if they can make generic buprenorphine?
4. How do label “manufactured for” vs “manufactured by” statements affect supplier identification?
5. What documentation should procurement request to qualify an alternate Sublocade supply lot source?

References

1. FDA. Prescribing Information for Sublocade (buprenorphine extended-release injectable) and related labeling/manufacturer statements. US FDA.
2. FDA. Orange Book and drug approval packages for Sublocade (buprenorphine extended-release injectable). US FDA.
3. FDA. FDA databases for NDC labeling and manufacturer/site listings for finished drug products. US FDA.