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Suppliers and packagers for carac
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carac
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Extrovis | CARAC | fluorouracil | CREAM;TOPICAL | 020985 | NDA AUTHORIZED GENERIC | Dr. Reddy's Laboratories Inc. | 75907-169-11 | 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE | 2025-07-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: CARAC
Introduction
CARAC (5-Fluorocytosine) is an antifungal and chemotherapeutic agent primarily used in the treatment of fungal infections and certain types of cancer. Its prominence in clinical settings necessitates a reliable supply chain comprising diverse manufacturers and distributors globally. This comprehensive analysis explores the key suppliers of CARAC, their manufacturing capabilities, market positioning, regulatory compliance, and supply chain dynamics critical for stakeholders seeking dependable procurement sources.
Overview of CARAC and Market Demand
CARAC, chemically known as 5-Fluorocytosine, is on the World Health Organization's (WHO) list of essential medicines, underscoring its importance in antifungal therapy, notably for cryptococcal meningitis and candidiasis management. Its production involves complex chemical synthesis and strict regulatory oversight, making supplier selection crucial for quality assurance and consistent supply. The demand has surged in regions with high burdens of fungal infections, especially in sub-Saharan Africa and parts of Asia, amplifying the importance of a diversified supplier base.
Key Manufacturers of CARAC
1. Actavis/Teva Pharmaceutical Industries
- Profile: One of the leading global generic pharmaceutical companies, Teva acquired Actavis' generics division, consolidating its role in producing 5-Fluorocytosine.
- Manufacturing Capabilities: Teva's infrastructure includes large-scale active pharmaceutical ingredient (API) synthesis facilities compliant with Good Manufacturing Practices (GMP).
- Market Position: Recognized for high-quality standards, supply stability, and global distribution networks, Teva supplies CARAC across North America, Europe, and emerging markets.
2. Sandoz (Novartis)
- Profile: Sandoz, Novartis' generics arm, manufactures a broad portfolio of essential medicines, including antifungals like CARAC.
- Manufacturing Capabilities: Sandoz operates state-of-the-art facilities adhering to international regulatory standards, ensuring consistent API quality.
- Market Position: Known for reliable global distribution and a focus on developing markets, Sandoz's supply chain for CARAC is robust and dependable.
3. Zhejiang Tianyuan Pharmaceutical Co., Ltd.
- Profile: Based in China, Zhejiang Tianyuan specializes in the synthesis of active pharmaceutical ingredients, including 5-Fluorocytosine.
- Manufacturing Capabilities: The company boasts advanced chemical synthesis technology, with GMP-certification, targeting both domestic and export markets.
- Market Position: A key supplier for Asian markets, Zhejiang Tianyuan offers competitive pricing but may have varying regulatory recognition internationally.
4. China Pharmaceutical University & Associated Manufacturers
- Profile: Several university-affiliated facilities and smaller producers in China manufacture 5-Fluorocytosine, often for research and limited commercial use.
- Manufacturing Capabilities: Capable of producing high-purity API but may lack large-scale commercial output and international regulatory approvals.
5. Other Regional Manufacturers
- Countries such as India, Argentina, and South Korea host pharmaceutical firms producing 5-Fluorocytosine, often catering to regional needs. These manufacturers vary in compliance standards, scale, and supply reliability.
Regulatory Considerations and Certification
The supply of CARAC is governed by stringent regulatory standards due to its role as an essential medicine. Suppliers must possess certifications such as GMP (Good Manufacturing Practice) from authoritative bodies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or equivalent national regulators.
- FDA-Approved Suppliers: Teva and Sandoz hold FDA approvals, ensuring their products meet the highest quality and safety standards.
- EMA & WHO Certification: Suppliers aiming for European or international markets seek EMA approval or WHO prequalification to enhance credibility and market access.
It is critical for procurement organizations to verify supplier certifications and compliance documentation before executing procurement contracts, especially for low- and middle-income country markets.
Supply Chain Dynamics and Challenges
Supply stability for CARAC faces multiple challenges:
- Raw Material Availability: Fluctuations in sourcing fluorinated intermediates and chemicals impact manufacturing continuity.
- Regulatory Changes: Evolving standards and approvals can disrupt cross-border shipments and market access.
- Manufacturing Capacity Constraints: Limited capacity among key suppliers could lead to shortages during peak demand or geopolitical disruptions.
- Pricing Pressures: Competitive markets, especially in Asia, influence drug pricing but may impact quality assurance if cost-cutting measures are taken.
Countermeasures include diversifying suppliers, engaging with WHO-prequalified manufacturers, and establishing long-term supply agreements.
Future Trends and Opportunities
- Bioequivalent and Novel Formulations: Innovation in formulations, such as extended-release versions, could expand supplier opportunities.
- Manufacturing Capacity Expansion: Investments by Chinese and Indian manufacturers aim to enhance API production, stabilizing supply.
- Regulatory Harmonization: Streamlined approvals can facilitate faster market access, especially for generic API manufacturers.
- Supply Chain Transparency: Emphasis on traceability and quality audits will be pivotal in mitigating counterfeit risks and ensuring compliance.
Key Takeaways
- Reliable suppliers include Teva, Sandoz, and Zhejiang Tianyuan, with their respective global footprints, compliance standards, and capacity to meet market demand.
- Certification and regulatory compliance are non-negotiable for ensuring safety, efficacy, and market access; verify GMP and approval status before procurement.
- Supply chain resilience depends on diversifying sources, monitoring geopolitical risks, and establishing strategic partnerships.
- Regional manufacturers may offer cost advantages but require rigorous quality vetting for international markets.
- Emerging markets represent growing demand zones, emphasizing the need for scalable, compliant manufacturing partnerships.
FAQs
Q1: Is CARAC supplied solely by large pharmaceutical companies?
A1: No, while established players like Teva and Sandoz dominate, regional Chinese and Indian manufacturers also supply CARAC, primarily targeting local or regional markets.
Q2: How can procurement agencies verify supplier quality for CARAC?
A2: By reviewing GMP certifications, WHO prequalification, regulatory approvals (FDA, EMA), and conducting audits or third-party quality assessments.
Q3: Are there supply risks associated with CARAC?
A3: Yes, potential risks include raw material shortages, manufacturing capacity constraints, regulatory delays, and geopolitical tensions impacting imports.
Q4: What role does WHO prequalification play for CARAC suppliers?
A4: It enhances credibility and facilitates procurement in low- and middle-income countries, ensuring product quality and safety.
Q5: Are there ongoing efforts to diversify CARAC manufacturing sources?
A5: Yes, investments by Asian pharmaceutical firms aim to expand capacity and diversify the supply chain, reducing reliance on a limited number of producers.
Conclusion
An assured supply of CARAC hinges on a diversified network of certified, compliant manufacturers operating at scale. Stakeholders must prioritize quality assurance, regulatory adherence, and supply chain resilience to ensure continuous access to this critical medicine. Strengthening collaborations with established suppliers like Teva and Sandoz, while exploring emerging regional producers, will be pivotal in maintaining stable supply streams amid evolving market and geopolitical landscapes.
Sources:
- World Health Organization, WHO Model List of Essential Medicines.
- FDA website, Approved Drug Master Files.
- Teva Pharmaceuticals official publications and certifications.
- Sandoz Corporate Overview.
- Zhejiang Tianyuan Pharmaceutical Co., Ltd. official disclosures.
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