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Suppliers and packagers for epivir-hbv
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epivir-hbv
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-478-60 | 60 TABLET, FILM COATED in 1 BOTTLE (66993-478-60) | 2014-09-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EPIVIR-HBV
Introduction
EPIVIR-HBV, formulated as pegylated interferon alpha-2a, is primarily indicated for the treatment of chronic hepatitis B virus (HBV) infection. It is a vital therapeutic option for reducing viral load and delaying disease progression in affected patients. Given its specialized nature, the supply chain for EPIVIR-HBV involves a select group of manufacturers and distributors with robust capabilities in biopharmaceutical production. This article examines the key suppliers, manufacturing dynamics, regulatory landscape, and implications for stakeholders.
Overview of EPIVIR-HBV
EPIVIR-HBV, marketed commercially under the name Heplisav-B by Valneva and other brands, is a pegylated version of interferon alpha-2a designed to improve pharmacokinetics and patient compliance. Although primarily used for hepatitis B, its production involves advanced recombinant DNA technology, cell culture systems, and stringent quality controls. The global demand for EPIVIR-HBV has increased in line with rising hepatitis B prevalence, especially in endemic regions.
Major Suppliers and Manufacturers
1. Valneva SE
Valneva is the primary approved manufacturer of EPIVIR-HBV, commercially marketed under the brand Heplisav-B. The company's manufacturing facilities in Vienna, Austria, utilize state-of-the-art bioreactor systems and purification processes to produce high-quality pegylated interferon alpha-2a. Valneva's integrated supply chain encompasses raw material procurement, fermentation, pegylation, formulation, and packaging.
Key attributes:
- Focused on hepatitis B vaccines and therapeutics.
- Extensive clinical development resources ensuring supply stability.
- Robust manufacturing capacity aligned with global regulatory standards (EMA, FDA).
2. Other Biopharmaceutical Contract Manufacturers
Several Contract Manufacturing Organizations (CMOs) partner with Valneva and other pharmaceutical firms to scale production, especially due to increased demand. These CMOs often specialize in recombinant protein production, such as:
- Boehringer Ingelheim: Known for biologics manufacturing, including interferon-based therapies.
- Samsung Biologics: Capable of large-scale biopharmaceutical production, including pegylated proteins.
- WuXi Biologics: Offers comprehensive IDA (integrated drug development and manufacturing) services for biologics.
While these CMOs do not directly market EPIVIR-HBV, they are integral to the supply chain, providing manufacturing capacity, process development, and quality assurance.
3. Raw Material Suppliers
The complex production of EPIVIR-HBV requires high-purity raw materials, including:
- Recombinant DNA vectors and enzymes: Suppliers like Thermo Fisher Scientific and New England Biolabs provide critical reagents.
- Pegylation agents: Methoxypolyethylene glycol (mPEG) derivatives supplied by brands such as NOF Corporation or Ascendis Pharma.
- Cell culture media: Thermo Fisher Scientific, Sartorius, and Lonza supply mega-batch media necessary for fermentation.
The reliability and quality of these raw materials directly influence the quality and stability of the final product.
Regulatory and Supply Chain Considerations
The supply chain is subject to rigorous regulatory oversight by agencies such as the U.S. FDA, EMA, and ICH guidelines, which impact manufacturing practices, batch releases, and distribution. The complex nature of biologics manufacturing introduces vulnerabilities, including susceptibility to production delays, capacity constraints, or disruptions in raw material supply.
In recent years, supply shortages of biologics like EPIVIR-HBV have occasionally occurred, often linked to supply chain disruptions caused by global events such as the COVID-19 pandemic. These episodes underscore the importance of diversified supplier bases and strategic inventory management.
Emerging Trends and Future Outlook
1. Increased Contract Manufacturing Engagement
As demand for hepatitis B therapies escalates, pharmaceutical companies are increasingly partnering with CMOs to augment production capacity, mitigate risks, and reduce costs. This trend ensures a more resilient supply chain but also requires stringent oversight to maintain compositional consistency.
2. Supply Chain Diversification
Stakeholders are emphasizing diversification of raw material providers and manufacturing sites to prevent bottlenecks. Companies are exploring regional manufacturing hubs in Asia, Europe, and North America to strengthen supply resilience.
3. Innovation in Supply Chain Technologies
Implementation of digital supply chain management tools, real-time monitoring, and blockchain-based tracking are becoming prevalent, helping to enhance transparency, traceability, and quality assurance across the manufacturing and distribution network.
Implications for Stakeholders
- Pharmaceutical Companies: Must secure multiple supply agreements, invest in capacity planning, and monitor raw material backlogs.
- Healthcare Providers: Need to be cognizant of potential supply disruptions and establish communication channels with manufacturers.
- Patients: Increased demand and supply variability warrant efforts to ensure continuous access and minimize treatment interruptions.
- Regulators: Play a critical role in overseeing quality control, facilitating transparency, and overseeing import-export regulations for biologics.
Key Takeaways
- Valneva SE remains the primary supplier of EPIVIR-HBV, supported by robust biologics manufacturing infrastructure.
- Contract manufacturing organizations are pivotal in scaling global supply, with partnerships increasing in response to rising demand.
- Raw material sourcing complexity underpins the entire supply chain’s vulnerability; diversification is critical.
- Regulatory oversight ensures product quality but can also impact supply continuity due to compliance delays or restrictions.
- Forward-looking strategies emphasize supply chain resilience, technological integration, and regional manufacturing expansion.
FAQs
1. Who are the main manufacturers of EPIVIR-HBV?
Valneva SE is the primary manufacturer, with extensive partnerships with CMOs such as WuXi Biologics, Samsung Biologics, and others for scaling production.
2. How is the supply chain for EPIVIR-HBV managed?
It involves raw material sourcing from specialized suppliers, biologics manufacturing by CMOs, and stringent regulatory oversight to maintain quality and supply stability.
3. What challenges does the supply chain for EPIVIR-HBV face?
Disruptions in raw material availability, capacity constraints, regulatory delays, and global health crises like COVID-19 pose significant challenges.
4. Are there regional differences in the supply of EPIVIR-HBV?
Yes. While Europe and North America primarily source from Valneva's facilities, emerging markets increasingly rely on regional manufacturing hubs and importation.
5. What are future trends affecting EPIVIR-HBV supplies?
Increased use of digital supply chain management, diversification of raw material sources, regional manufacturing expansion, and strategic stockpiling.
References
[1] Valneva SE: Heplisav-B Product Information.
[2] World Health Organization. Hepatitis B Fact Sheet.
[3] Contract Manufacturer Capabilities for Biologics. Biopharma Industry Reports.
[4] Regulatory Guidelines for Biologics Manufacturing. ICH Q5A, EMA, FDA.
[5] Supply Chain Strategies for Biologics. Industry Outlook.
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