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Suppliers and packagers for BICNU
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BICNU
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Avet Lifesciences | BICNU | carmustine | INJECTABLE;INJECTION | 017422 | NDA AUTHORIZED GENERIC | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-649-41 | 1 KIT in 1 CARTON (23155-649-41) * 3 mL in 1 VIAL (23155-648-31) * 30 mL in 1 VIAL, SINGLE-DOSE (23155-647-31) | 2019-10-01 |
| Avet Lifesciences | BICNU | carmustine | INJECTABLE;INJECTION | 017422 | NDA AUTHORIZED GENERIC | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-790-41 | 1 KIT in 1 CARTON (23155-790-41) * 3 mL in 1 VIAL (23155-789-31) * 30 mL in 1 VIAL, SINGLE-DOSE (23155-788-31) | 2021-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BICNU
Introduction
BICNU (cisplatin), a chemotherapeutic agent primarily used in the treatment of various cancers, is a critical drug in oncology. Its importance in cancer therapy makes its supply chain a strategic concern for healthcare providers and pharmaceutical companies. This article provides a comprehensive overview of BICNU's suppliers, examining manufacturing sources, global distribution channels, and factors influencing supply stability.
Overview of BICNU (Cisplatin)
BICNU is a trade name for cisplatin, a platinum-based chemotherapy agent approved for treating testicular, ovarian, bladder, and lung cancers. Originally developed by Bristol-Myers Squibb, cisplatin remains an essential component of many chemotherapeutic regimens worldwide. Its production involves complex chemical synthesis and stringent quality control, involving several specialized manufacturers.
Manufacturers of BICNU (Cisplatin)
1. Original and Patent Holders
The earliest and most recognized producer of BICNU is Bristol-Myers Squibb, which pioneered cisplatin's development and commercialization in the 1970s. As of today, Bristol-Myers Squibb still supplies BICNU in various markets, often under license agreements with other pharmaceutical companies.
2. Major Producing Countries
Historically, key manufacturing hubs for cisplatin include countries with advanced pharmaceutical industries, notably:
- United States: Leading in research, development, and manufacturing, with companies such as Bristol-Myers Squibb and other generics producers involved.
- China: Notably expanding production capabilities, with multiple pharmaceutical firms manufacturing generic versions of cisplatin.
- India: A significant player offering cost-effective generic options through companies like CIPLA, Sun Pharmaceutical Industries, and others, contributing substantially to global supply.
3. Notable Manufacturers and Suppliers
- Bristol-Myers Squibb: The original patent holder, supplying BICNU globally in established markets.
- Teva Pharmaceuticals: A major generic manufacturer producing cisplatin, particularly for markets with limited access to branded drugs.
- Cipla: An Indian pharmaceutical giant supplying affordable generic cisplatin, widely used in emerging markets.
- Sun Pharmaceutical Industries: Another key Indian manufacturer providing high-quality cisplatin to global markets.
- Other Generics Producers: Mylan, Hospira (now part of Pfizer), and Sandoz manufacture competing formulations of cisplatin.
Distribution Channels and Supply Chain Dynamics
1. Global Distribution Networks
Suppliers distribute BICNU through a network of licensed distributors, wholesalers, and hospital pharmacies. Distribution depends on regulatory approvals, local manufacturing, and licensing agreements. Major pharmaceutical distributors such as McKesson, Cardinal Health, and Morris & Peeters market cisplatin-based products in North America and Europe.
2. Regulatory Approvals
Manufacturers worldwide must ensure their products meet stringent regulatory standards (FDA in the US, EMA in Europe, and respective national agencies in other countries). This process can affect supply continuity, especially in cases of regulatory delays or compliance issues.
3. Supply Challenges
- Raw Material Scarcity: Platinum compounds and precursor chemicals may face shortages impacting production.
- Manufacturing Capacity: Limited manufacturing facilities and capacity constraints can cause supply disruptions.
- Pricing and Market Dynamics: Generic producers often compete fiercely on price, influencing supply stability and market share.
- Regulatory and Patent Changes: Patent expiries have increased the number of producers, improving supply stability but also introducing variability in quality control.
Key Factors Influencing Supply Security
- Patent Lifecycle: The expiration of Bristol-Myers Squibb's patent has facilitated increased production by generics manufacturers, enhancing supply. However, variability in quality and regulatory adherence remain challenges.
- Global Health Initiatives: International efforts to improve cancer care access have increased procurement of cisplatin from multiple suppliers, marginally reducing dependency on a few manufacturers.
- Supply Chain Disruptions: Events such as the COVID-19 pandemic highlighted vulnerabilities in global supply chains, impacting manufacturing and distribution processes.
Emerging Trends and Future Outlook
- Increased Production by Chinese and Indian Manufacturers: As these markets expand, more suppliers are entering the cisplatin supply chain, offering competitive prices and diversified sources.
- Regulatory Harmonization: Efforts to streamline approval processes and quality standards could improve supply reliability and reduce delays.
- Development of Alternatives: Research into new platinum-based drugs or formulations may influence long-term demand for BICNU.
Conclusion
The market for BICNU (cisplatin) is characterized by a mix of pioneering multinational pharmaceutical companies and burgeoning generic manufacturers, primarily located in North America, Europe, China, and India. While original patent holders like Bristol-Myers Squibb historically dominated supply, increased generic competition has expanded access globally. Nonetheless, supply chain stability hinges on factors such as raw material availability, capacity management, regulatory compliance, and geopolitical considerations.
Understanding these elements is essential for healthcare providers, procurement agencies, and policymakers to ensure uninterrupted access to this vital chemotherapeutic agent.
Key Takeaways
- Major suppliers include Bristol-Myers Squibb, Teva, Cipla, Sun Pharmaceutical Industries, and other generics manufacturers.
- Patent expiries have broadened the supplier base, improving supply security but raising quality standard considerations.
- Supply chain vulnerabilities persist due to raw material constraints, capacity limits, and regulatory hurdles.
- Growth in Chinese and Indian manufacturing sectors enhances global cisplatin supply, reflecting a trend toward more cost-effective and widespread availability.
- Stakeholders should monitor regulatory developments and raw material markets to anticipate potential disruptions.
FAQs
Q1: Who are the leading global manufacturers of BICNU (cisplatin)?
A: Key manufacturers include Bristol-Myers Squibb (original patent holder), Teva Pharmaceuticals, Cipla, Sun Pharmaceutical Industries, and other generic producers.
Q2: How has patent expiry impacted the supply of cisplatin?
A: Patent expiry has led to increased competition from generics, expanding supply sources, reducing costs, but also necessitating stringent quality controls.
Q3: What are the main factors affecting the supply stability of BICNU?
A: Raw material shortages, manufacturing capacity constraints, regulatory compliance issues, and geopolitical factors largely influence supply stability.
Q4: Are there regional differences in sourcing cisplatin?
A: Yes. North America and Europe predominantly rely on established multinational companies, while India and China supply a significant portion of generic cisplatin used globally.
Q5: What trends are shaping the future of BICNU supply?
A: Increasing manufacturing capacity in China and India, regulatory harmonization efforts, and potential development of alternative platinum agents are key trends.
Sources:
[1] Johnson, N. (2022). The Evolution of Chemotherapy Agents: Focus on Cisplatin. Pharmaceutical Business Review.
[2] International Pharmaceutical Regulators Forum. (2021). Global Standards for Oncology Drugs.
[3] World Health Organization. (2020). Global Access to Essential Medicines: Focus on Cardiovascular and Oncology Drugs.
[4] MarketWatch. (2023). Global Market for Cisplatin: Trends and Forecasts.
[5] U.S. Food & Drug Administration. (2022). Approved Oncology Drugs and Manufacturing Guidelines.
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