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Suppliers and packagers for baraclude
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baraclude
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-1614-12 | 1 BOTTLE in 1 CARTON (0003-1614-12) / 210 mL in 1 BOTTLE | 2005-03-29 |
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-1611-12 | 1 BOTTLE in 1 CARTON (0003-1611-12) / 30 TABLET, FILM COATED in 1 BOTTLE | 2005-03-29 |
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-1612-12 | 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE | 2005-03-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BARACLUDE
Introduction
Baraclude (entecavir) is a prescription antiviral medication developed by Bristol-Myers Squibb for the treatment of chronic hepatitis B virus (HBV) infection. As a widely prescribed nucleotide analogue, its supply chain is pivotal for ensuring continuous access for patients worldwide. This article provides an in-depth analysis of the primary suppliers, manufacturing landscape, and market dynamics associated with Baraclude, essential for pharmaceutical stakeholders, healthcare providers, and investors seeking comprehensive insights into its procurement ecosystem.
Manufacturers and Production Facilities
Bristol-Myers Squibb (BMS), the originator of Baraclude, is the principal manufacturer responsible for the drug's global supply. The company operates several manufacturing facilities worldwide, primarily located in:
- United States (Eschikon, New Jersey): BMS’s primary manufacturing site, adhering to stringent cGMP (current Good Manufacturing Practice) standards, ensuring high-quality production.
- Puerto Rico: Additional manufacturing, leveraging regional infrastructure and resources.
- Ireland and other European facilities: For distribution across European markets.
BMS maintains strict control over production quality, quantity, and distribution logistics, often working with qualified contract manufacturing organizations (CMOs) to supplement its supply chain.
Contract Manufacturing Organizations (CMOs)**
While Bristol-Myers Squibb directly oversees the manufacturing of Baraclude, it occasionally partners with CMOs to meet rising global demand or address regional supply needs. These partnerships are typically kept confidential due to competitive and regulatory considerations but are critical for:
- Scaling production capacity.
- Reducing lead times in supply chains.
- Ensuring market-specific compliance.
Major CMOs specializing in antiviral or nucleotide analogue production include companies like Fujifilm Diosynth Biotechnologies, Samsung Biologics, and Lonza—though explicit associations regarding Baraclude remain proprietary.
Supply Chain Dynamics and Global Distribution
The drug's global distribution hinges on a tightly coordinated supply chain managed by BMS and its network. Baraclude’s primary markets include:
- United States and Canada
- European Union countries
- Asian markets (notably China, Japan, India)
- Latin America and Africa
BMS utilizes regional warehouses and distribution centers to ensure timely delivery. The supply chain is influenced by factors such as:
- Regulatory approvals and compliance in various jurisdictions.
- Raw material sourcing, particularly for enucleoside salts such as entecavir.
- Shelf-life stability and storage conditions, affecting inventory management.
- Global pandemics or geopolitical issues that can disrupt logistics and manufacturing.
Raw Material and API Suppliers
The active pharmaceutical ingredient (API) for Baraclude, entecavir, is synthesized through complex chemical processes involving multiple intermediates and catalysts. The suppliers of raw materials and intermediates are often specialized chemical companies operating under strict quality control standards, including:
- Lanxess (Germany): Known for specialty chemicals used in nucleoside analogs.
- Fujifilm Toyama Chemical Co. Ltd.: Sometimes involved in the synthesis process.
- Local Asian chemical suppliers: Particularly in China and India, which provide generic intermediates.
Entecavir’s raw material supply chain is vulnerable to fluctuations in the chemical manufacturing sector. Ensuring consistent, GMP-compliant sourcing is critical.
Regulatory and Quality Assurance
Leading suppliers must comply with global regulatory standards, including FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies. Quality assurance measures include:
- Validation of manufacturing processes.
- Batch testing and stability assessments.
- Traceability of raw materials.
These standards impact supplier selection and ongoing quality audits, influencing procurement strategies.
Market Competition and Generic Suppliers
While Bristol-Myers Squibb retains exclusivity for Baraclude, several generic manufacturers have entered the market following patent expiration. Key players include:
- Hetero Labs (India)
- Mylan (now part of Viatris)
- Dr. Reddy’s Laboratories
- Sun Pharma
These companies typically source APIs from regional chemical suppliers, produce generics under regulatory approval, and distribute through local and international channels.
Future Supply Considerations
Emerging biosimilar and generic competitors, coupled with patent challenges and market demand fluctuations, influence supplier strategies. Bristol-Myers Squibb’s commitment to maintaining a secure and quality-focused supply chain remains vital amid these market dynamics. Continuous investment in manufacturing capacity, quality systems, and strategic supplier relationships ensures resilience and access.
Key Takeaways
- Primary originator: Bristol-Myers Squibb, with manufacturing facilities globally, predominantly in the US and Europe.
- Contract manufacturing: Supplemented by CMOs with expertise in nucleotide analogue production.
- Raw material sourcing: Involves specialized chemical suppliers, mainly in Europe and Asia, for entecavir API and intermediates.
- Distribution network: Managed through regional warehouses and logistics partners to ensure steady global supply.
- Market competition: Includes several regional generic manufacturers, sourcing APIs locally and complying with regional regulations.
FAQs
1. Who are the main manufacturers of Baraclude?
Bristol-Myers Squibb is the primary manufacturer, utilizing its own facilities and partnerships with contract manufacturing organizations (CMOs) globally.
2. What regions supply raw materials for entecavir?
Key raw materials are sourced from chemical suppliers in Europe (Germany, Switzerland) and Asia (China, India), specializing in nucleoside synthesis.
3. Are there alternative suppliers for Baraclude’s active ingredient?
While BMS controls most of the production, several regional generics manufacturers source APIs from local chemical firms or produce entecavir under licensed agreements.
4. How do supply chain disruptions affect Baraclude availability?
Disruptions in raw material supply, manufacturing delays, or logistical issues can cause shortages, emphasizing the importance of diversified supplier relationships and contingency planning.
5. What are future trends influencing suppliers for Baraclude?
Emerging biosimilars, patent expirations, and increased demand for hepatitis B therapies are prompting suppliers to invest in capacity expansion and quality assurance enhancements.
Sources
[1] Bristol-Myers Squibb Official Website, "Baraclude (Entecavir)".
[2] FDA Drug Approval Database.
[3] Market research reports on hepatitis B drugs and generics.
[4] Chemical supplier directories and industry publications.
[5] Industry news articles on pharmaceutical manufacturing partnerships and capacity expansion.
In conclusion, the supply of Baraclude hinges on Bristol-Myers Squibb’s manufacturing excellence, strategic CMO partnerships, reliable raw material sourcing, and an adaptive global logistics network. Understanding these supply dynamics is crucial for stakeholders managing procurement, market entry, or investment decisions centered on hepatitis B therapeutics.
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