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Suppliers and packagers for generic pharmaceutical drug: bedaquiline fumarate
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bedaquiline fumarate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384 | NDA | Janssen Products, LP | 59676-701-01 | 188 TABLET in 1 BOTTLE (59676-701-01) | 2012-12-28 |
| Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384 | NDA | Janssen Products, LP | 59676-702-60 | 60 TABLET in 1 BOTTLE (59676-702-60) | 2020-05-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Bedaquiline Fumarate
Introduction
Bedaquiline fumarate, marketed under the brand name Sirturo, is a groundbreaking antimicrobial agent developed by Johnson & Johnson for treating multidrug-resistant tuberculosis (MDR-TB). Approved by the U.S. Food and Drug Administration (FDA) in 2012, it marked a major advance in TB treatment due to its novel mechanism targeting mycobacterial ATP synthase. As the global burden of MDR-TB persists, the demand for reliable suppliers of bedaquiline fumarate has grown. This article assesses the current landscape of suppliers for this critical drug, analyzing manufacturing sources, supply chain considerations, and strategic implications for stakeholders.
Manufacturing Landscape of Bedaquiline Fumarate
Original Manufacturer and Patent Holders
Johnson & Johnson was the pioneering entity in developing and commercializing bedaquiline fumarate. Its proprietary drug, Sirturo, benefited from exclusive rights for several years post-approval, limiting the number of authorized suppliers initially. The manufacturer’s global supply chain production was centralized, with strict quality controls governed by regulatory approvals and Good Manufacturing Practices (GMP).
Authorized Generic Production
Following patent expiration or licensing agreements, biosimilar and generic producers entered the market, expanding the supply base. While Johnson & Johnson retains patent protections in certain jurisdictions, several companies in emerging markets have received approval to manufacture generic bedaquiline fumarate, often under voluntary licensing or through compulsory licensing agreements.
Current Approved Suppliers
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Johnson & Johnson (Janssen Pharmaceuticals)
The primary original manufacturer, maintaining GMP-certified production facilities in the United States and Europe. -
Dr. Reddy’s Laboratories (India)
Received WHO prequalification for generic bedaquiline fumarate, enabling procurement through WHO channels and participating in global TB initiatives. -
Jiangsu Hengrui Medicine Co., Ltd. (China)
Reported as a manufacturer with approvals in China, aiming to meet national TB treatment demands. -
Cipla Limited (India)
Approved for generic production, with distribution primarily in developing nations. -
Shenzhen Second Pharmaceutical Factory (China)
Involved in the supply chain, particularly within Asian markets.
These suppliers, among others, align with global efforts to improve access, particularly in high-burden regions such as India, South Africa, and parts of Southeast Asia.
Global Supply Chain Dynamics
Regulatory Approvals and Quality Assurance
Manufacturers must meet stringent regulatory standards. WHO prequalification and approvals from agencies like the U.S. FDA, European Medicines Agency (EMA), and others serve as key benchmarks. The supply chain depends heavily on compliance, particularly in ensuring drug stability, bioavailability, and manufacturing consistency.
Manufacturing Capacity and Demand
The rising demand hinges on the global push to eradicate MDR-TB. Manufacturers scaled up production after WHO’s endorsement and global health organization funding initiatives. Yet, supply constraints persist, partly due to complex synthesis processes and the need for high-level containment measures, given the drug’s classification as a biosafety level 3 agent.
Distribution and Access Challenges
High costs, patent restrictions, and limited manufacturing facilities in certain regions hinder equitable access. Notably, generic producers in India and China dominate supply in low-to-middle-income countries. International organizations such as WHO and Global Drug Facility play pivotal roles in procurement and distribution.
Key Factors Influencing Supplier Selection
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Regulatory Compliance
Suppliers must demonstrate adherence to GMP standards, WHO prequalification, and regional approvals. -
Production Capacity & Reliability
The ability to meet global demand, especially during outbreaks or supply chain disruptions. -
Cost & Economic Viability
Competitive pricing influences procurement strategies in resource-limited settings. -
Supply Chain Security
Diversification of suppliers reduces risk of shortages, especially amid geopolitical or logistical challenges. -
Quality Control & Traceability
Establishing transparent supply chains ensures drug efficacy and safety.
Strategic Implications for Stakeholders
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Global Health Agencies
Must navigate complex licensing agreements and foster collaborations to expand the number of quality-assured suppliers. -
Manufacturers
Encouraged to increase capacity, streamline synthesis, and participate in international certifications to meet rising demand. -
Governments & Procurement Entities
Need to leverage diverse sources to prevent shortages and negotiate fair pricing, especially in high-burden regions. -
Pharmaceutical Companies
Opportunities exist for biosimilar entrants to expand market share through strategic licensing and technology transfer.
Regulatory and Market Developments
Recently, several companies, especially in the generic space, have sought and received approvals for bedaquiline fumarate production. The World Health Organization’s prequalification process remains a key facilitator, encouraging manufacturers to meet global standards. Furthermore, patent expirations in certain markets are expected to catalyze an influx of new suppliers, further stabilizing supply.
Conclusion
The landscape of suppliers for bedaquiline fumarate comprises a mix of original innovator companies, licensed generics, and regional manufacturers. Ensuring stable, high-quality supply requires ongoing regulatory vigilance, capacity expansion, and regional diversification. Stakeholders must continue to foster collaborations, promote technology transfer, and support regulatory harmonization to meet the escalating global demand for MDR-TB therapies.
Key Takeaways
- Johnson & Johnson remains a primary supplier, with multiple generic producers emerging post-patent expiry.
- WHO prequalification and regional approvals significantly influence supplier credibility and market access.
- Growth in manufacturing capacity, especially in India and China, is critical to meeting global MDR-TB treatment needs.
- Diversification of suppliers stabilizes supply and reduces dependency risks.
- Regulatory milestones and patent expirations will shape the future supply landscape, opening opportunities for new entrants.
Frequently Asked Questions
1. Who are the main suppliers of bedaquiline fumarate globally?
The primary supplier is Johnson & Johnson (Janssen). Key generic producers include Dr. Reddy’s Laboratories, Cipla, Jiangsu Hengrui Medicine, and Shenzhen Second Pharmaceutical Factory, among others.
2. What factors determine the quality of bedaquiline fumarate from different suppliers?
Regulatory compliance (WHO prequalification, FDA, EMA approvals), GMP standards, manufacturing process controls, and batch consistency are critical determinants.
3. How do patent laws affect the supply of bedaquiline fumarate?
Patent protections limit generic manufacturing initially. Expiry or licensing agreements enable more producers to enter the market, increasing supply.
4. Is bedaquiline fumarate restricted to certain regions?
While originally approved in the U.S. and Europe, generic versions are widely available in Asia, Africa, and other low-to-middle-income regions, facilitated by WHO prequalification and regional authorization.
5. What are the supply challenges facing bedaquiline fumarate today?
Manufacturing complexities, regulatory hurdles, patent restrictions, high costs, and logistical issues contribute to supply constraints, particularly in high-demand settings.
Sources:
[1] WHO Prequalification of Medicines Program. (2022). Bedaquiline.
[2] U.S. Food and Drug Administration. (2012). FDA Approves New Drug for Multidrug-Resistant Tuberculosis.
[3] Johnson & Johnson. (2022). Sirturo (bedaquiline) Product Information.
[4] Global Drug Facility. (2022). Tuberculosis Medicines Supply Forecast.
[5] Cipla Limited. (2021). Product Approvals and Certifications.
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