Share This Page
Suppliers and packagers for sublocade
✉ Email this page to a colleague
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SUBLOCADE
Introduction
SUBLOCADE (buprenorphine XR) is a long-acting subcutaneous injectable formulation approved for the treatment of opioid use disorder (OUD). As an extended-release formulation of buprenorphine, SUBLOCADE offers patients a monthly dosing option, improving adherence and reducing diversion risks associated with daily oral medications. The manufacturing and supply chain dynamics of SUBLOCADE are pivotal to ensuring its availability across healthcare markets. This article provides a comprehensive overview of the key suppliers involved in the production, distribution, and supply chain of SUBLOCADE, emphasizing their roles, strategic importance, and implications for stakeholders.
Manufacturing of SUBLOCADE
Principal Manufacturer: Indivior
Indivior PLC, a leading pharmaceutical company specializing in addiction treatment medications, is the primary developer and manufacturer of SUBLOCADE. The company's expertise in formulation science, particularly in extended-release injectables, positions it as the sole supplier of this specific drug formulation.
Manufacturing Facilities:
Indivior operates multiple manufacturing facilities globally, with the primary production of SUBLOCADE occurring at specialized facilities compliant with Good Manufacturing Practices (GMP). These facilities feature advanced fill-finish lines, sterile processing units, and quality assurance systems designed for injectable products.
Capacity and Scalability:
Indivior has invested significantly to ensure scalable production capacity, aligning with the growing demand for OUD treatments. However, manufacturing complexity, especially in sterile injectable production, constrains rapid capacity expansion, making supply chain management critical.
Quality Assurance:
Strict regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) ensures product safety, efficacy, and consistent quality, which inherently links supply stability to rigorous manufacturing standards.
Raw Material Suppliers
The production of SUBLOCADE hinges on high-quality raw materials, notably buprenorphine active pharmaceutical ingredient (API) and specialized excipients for injectable formulations.
Buprenorphine API Suppliers:
Indivior sources buprenorphine API from multiple contract manufacturers, predominantly based in India and China, owing to their established APIs manufacturing capabilities.
- Key API Manufacturers:
- Sun Pharmaceutical Industries (India): A leading supplier for numerous opioid APIs, known for robust quality controls.
- Hubei Yionai Medical Tool Co. Ltd. (China): Specializes in opioid APIs with competitive pricing.
Excipients and Other Components:
Additional components for the formulation, such as solvents, stabilizers, and sterilization agents, are procured from global suppliers specializing in pharmaceutical-grade materials.
Supply Chain Partners and Distributors
Once manufactured, SUBLOCADE is distributed through a network of specialized pharmaceutical distributors to ensure broad access across hospitals, clinics, and specialty pharmacies.
-
Distribution Partners:
Major distributors include AmerisourceBergen, McKesson Corporation, and Cardinal Health. These entities handle storage, cold chain logistics, and delivery logistics, ensuring product integrity during transit. -
Specialty Pharmacies:
Given the specialized nature of SUBLOCADE, distribution often involves licensed specialty pharmacies directly serving clinics specializing in addiction treatment.
Supply Chain Challenges and Strategies
Complexity of Injectable Manufacturing
The sterile, extended-release formulation requires precise manufacturing, quality control, and cold chain logistics to prevent degradation. Any disruption at the manufacturing level can cause delays and shortages.
Regulatory Constraints
Regulatory compliance across multiple jurisdictions entails rigorous audits and quality inspections, which can impact supply timelines. Variability in regulatory approvals and manufacturing standards poses challenges for global supply expansion.
Global Raw Material Dependencies
The reliance on API manufacturing in India and China exposes the supply chain to geopolitical risks, trade tariffs, and pandemic-related disruptions, which have historically impacted pharmaceutical supply chains.
Strategic Risk Management
Indivior has adopted multiple strategies, including sourcing API from multiple suppliers and maintaining safety stock levels to mitigate supply interruptions. Collaborative planning with distribution partners and contingency planning remain critical.
Emerging Suppliers and Competition
Market Entrants and Licensing
Although Indivior holds exclusive rights to SUBLOCADE, the broader buprenorphine extended-release market is witnessing increased competition. Several pharmaceutical companies explore biosimilars or alternative formulations to challenge Indivior’s market dominance, potentially affecting supply chain dynamics.
Potential Contract Manufacturing Organizations (CMOs)
The pharmaceutical industry increasingly shifts toward outsourcing sterile injectable production to specialized CMOs to expand capacity and mitigate risks. Current and future collaborations with CMOs may diversify the supplier landscape but also introduce supply chain complexity.
Implications for Stakeholders
Healthcare Providers and Patients
Supply stability of SUBLOCADE remains vital to ensuring uninterrupted treatment for patients with OUD. Any disruptions directly impact treatment adherence, recovery outcomes, and public health initiatives.
Pharmaceutical and Distribution Companies
Manufacturers and distributors must sustain tight quality controls, robust logistics, and contingency planning to prevent shortages and meet escalating demand.
Regulatory Bodies
Regulators play a critical role in scrutinizing manufacturing quality, facilitating supply chain transparency, and expediting approvals for alternative suppliers or new manufacturing sites to enhance supply resilience.
Future Outlook
The global focus on addressing the opioid epidemic is likely to drive sustained demand for SUBLOCADE. Indivior’s ongoing investments in manufacturing capacity, supply chain diversification, and strategic partnerships with third-party manufacturers are expected to bolster supply stability. Concurrently, policy shifts emphasizing overdose prevention and increased access to medication-assisted treatment (MAT) will amplify market needs, necessitating a resilient and adaptable supply chain network.
Key Takeaways
- Indivior remains the sole manufacturer of SUBLOCADE, leveraging specialized facilities for sterile injectable production.
- API sourcing is predominantly from Indian and Chinese manufacturers, highlighting geopolitical and supply chain risk factors.
- Global distribution networks, primarily through major pharmaceutical distributors and specialty pharmacies, coordinate the supply of SUBLOCADE, ensuring access across healthcare settings.
- Supply chain complexities, including manufacturing, regulatory compliance, and raw material dependencies, pose ongoing challenges, mitigated through strategic planning and diversification.
- Market growth and increasing demand underscore the importance of resilient supply chains, with future expansions potentially involving new manufacturing partnerships.
FAQs
1. Who are the primary manufacturers of the buprenorphine API used in SUBLOCADE?
The API is mainly sourced from Indian companies like Sun Pharmaceutical Industries and Chinese manufacturers such as Hubei Yionai Medical. These firms meet stringent quality standards for pharmaceutical-grade APIs.
2. How does Indivior ensure the quality and safety of SUBLOCADE throughout its supply chain?
Indivior adheres to GMP standards, conducts rigorous quality testing at manufacturing sites, and maintains regulatory compliance across jurisdictions, ensuring consistent product safety and efficacy.
3. What are the primary logistical challenges in distributing SUBLOCADE?
Its injectable, extended-release formulation requires cold chain logistics, sensitive handling, and precise inventory management across global distribution networks to prevent degradation and ensure timely delivery.
4. Are there any emerging competitors or alternative suppliers for SUBLOCADE?
Currently, Indivior holds exclusive rights; however, biosimilar development and new formulations are in exploration stages, which could introduce competition or alternative sourcing options in the future.
5. What strategies are in place to mitigate supply chain risks for SUBLOCADE?
Indivior and partners employ multiple sourcing arrangements, safety stock inventories, and diversified distribution channels to mitigate risks stemming from manufacturing disruptions, geopolitical issues, or raw material shortages.
References
[1] Indivior PLC. “SUBLOCADE (buprenorphine extended-release) Prescribing Information.” 2022.
[2] FDA. “Approval of SUBLOCADE for Opioid Use Disorder.” Federal Register, 2018.
[3] IMS Health Data. “Global API Market Overview.” 2021.
[4] MarketWatch. “The Future of Opioid Use Disorder Treatments.” 2022.
[5] World Health Organization. “Guidelines for the Pharmacological Treatment of Opioid Dependence.” 2018.
More… ↓
