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Suppliers and packagers for LOMUSTINE
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LOMUSTINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Carnegie | LOMUSTINE | lomustine | CAPSULE;ORAL | 219265 | ANDA | Carnegie Pharmaceuticals LLC | 80005-114-02 | 5 CAPSULE in 1 BOTTLE (80005-114-02) | 2025-11-10 |
| Carnegie | LOMUSTINE | lomustine | CAPSULE;ORAL | 219265 | ANDA | Carnegie Pharmaceuticals LLC | 80005-115-02 | 5 CAPSULE in 1 BOTTLE (80005-115-02) | 2025-11-10 |
| Carnegie | LOMUSTINE | lomustine | CAPSULE;ORAL | 219265 | ANDA | Carnegie Pharmaceuticals LLC | 80005-116-02 | 5 CAPSULE in 1 BOTTLE (80005-116-02) | 2025-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lomustine
Introduction
Lomustine, also known by its chemical name, 1-[2-Chloroethyll]-1-nitrosourea, is an alkylating chemotherapeutic agent primarily used to treat brain tumors, Hodgkin’s lymphoma, and other malignancies. Its mechanism involves cross-linking DNA, leading to cell death. Given its critical role in oncology therapeutics, understanding the supply landscape is essential for pharmaceutical companies, healthcare providers, and investors aiming to ensure drug availability, manage procurement strategies, or assess market competition.
This article provides a comprehensive review of the primary suppliers of lomustine, analyzing their manufacturing capacities, regulatory statuses, geographic footprints, and future outlooks within the global pharmaceutical supply chain.
Manufacturers of Lomustine
1. Historically Anchor Firms:
Lomustine was first developed and marketed in the 1960s. Over decades, several pharmaceutical companies historically produced it, but due to the generic nature of the compound and market consolidation, availability is now concentrated among a few key players.
2. Major Global Suppliers
MediChem Life Sciences Inc. / Teva Pharmaceuticals
- Product Profile: Teva Pharmaceuticals is a leading generic pharmaceutical manufacturer globally. They produce a broad spectrum of chemotherapy agents, including lomustine, under strict regulatory compliance.
- Manufacturing & Supply: Their manufacturing facilities are licensed and inspected per FDA, EMA standards, with extensive distribution networks, making them a primary supplier for North America, Europe, and other markets.
- Regulatory Status: Teva’s versions of lomustine have received approval or are marketed under legal exemptions in multiple countries, ensuring broad availability.
Hospira (A Pfizer Company)
- Product Profile: Hospira, acquired by Pfizer in 2015, specializes in sterile injectable drugs, including chemotherapeutics.
- Supply Chain: Although Hospira primarily focused on injectables, it supplied lomustine formulations in certain markets or through licensing agreements.
- Regulatory & Distribution: Pfizer's global infrastructure helps maintain the availability of lomustine formulations in North America and select markets.
Pernix Therapeutics and Other Generics
- Several regional generic manufacturers, such as Pernix Therapeutics, produce lomustine primarily for North American markets.
- Manufacturing Capacities: Shared manufacturing facilities located in India and China (discussed further below) support regional supply but are often subject to quality regulatory scrutiny.
Regional Suppliers and Market Dynamics
India and China: Growing Centers
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India: Several Indian pharmaceutical companies, including Sun Pharma, Cipla, and Dr. Reddy’s Laboratories, manufacture low-cost versions of various chemotherapeutic agents. While lomustine is not widely marketed as a branded product, they often produce active pharmaceutical ingredients (APIs) with a few formulations reaching export markets.
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China: Major API producers such as Zhejiang Hisun Pharmaceutical and Shanghai IVY Pharmaceutical produce lomustine APIs, mainly exporting to India and other markets. These suppliers often operate under Good Manufacturing Practices (GMP), but their products may vary in regulatory acceptance.
API Suppliers
Lomustine’s supply chain hinges heavily on API producers, with many operating as OEM (original equipment manufacturer) providers. These APIs are then formulated into finished dosage forms by regional manufacturers.
Key API Suppliers Include:
- Zhejiang Hisun Pharmaceutical (China): Known for producing APIs used in oncology drugs, including lomustine.
- Macleods Pharmaceuticals (India): Offers APIs for anticancer agents, including alkylating agents.
- Hikma Pharmaceuticals: Occasionally involved in the distribution of chemotherapeutic APIs.
Regulatory Considerations and Market Access
Quality assurance remains paramount. Suppliers must adhere to stringent GMP standards established by FDA, EMA, or corresponding regulators. Notably, the Chinese and Indian API manufacturers often seek certifications such as ISO 9001 and WHO-GMP to facilitate exports.
Market access depends on regulatory approvals; while European and North American markets tend to favor suppliers with strict compliance, emerging markets may accept APIs or finished drugs from suppliers with less stringent validation, which can impact global supply integrity.
Future Outlook: Supply Chain Trends and Risks
Consolidation and Generic Competition:
The scarcity of brand-name lomustine formulations has led to reliance on generics, thus heightening competition among suppliers. Patent expirations and improved manufacturing processes are driving down prices and expanding supplier options.
API Production Risks:
API manufacturing in China and India faces risk factors, including geopolitical tensions, regulatory crackdowns, and quality control issues. Recent increased scrutiny by US and European regulators has led some suppliers to modernize facilities or seek certifications to ensure continued market access.
Supply Chain Resilience:
The COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting pharmaceutical companies to diversify supply sources. Consequently, companies are now exploring multiple API and finished product suppliers to mitigate shortages.
Emerging Players and Innovation:
Some biotech startups and mid-sized manufacturers are investing in novel production methods or biosimilars, potentially influencing the lomustine supply landscape in the coming decade—though their impact remains limited due to regulatory hurdles.
Conclusion
The supply of lomustine predominantly depends on a limited number of global generic pharmaceutical companies and API producers, mainly situated in Europe, North America, India, and China. Established firms like Teva and Pfizer via Hospira ensure broad, regulated access, while regional manufacturers in India and China expand the supply base, often focusing on API exports.
Dependencies on API manufacturing hubs pose ongoing risks, accentuating the importance of supply chain diversification and regulatory compliance. As the pharmaceutical industry evolves, partnerships, certifications, and technological advancements will shape the future of lomustine’s availability worldwide.
Key Takeaways
- Major suppliers include Teva Pharmaceuticals, Pfizer (Hospira), and regional API manufacturers in India and China.
- The supply landscape is characterized by a reliance on API producers, with finished formulations often made by regional generics.
- Regulatory adherence and GMP compliance are critical for supplier acceptance in developed markets.
- Supply chain risks stem from geopolitical factors, manufacturing quality concerns, and pandemic-related disruptions.
- Diversification of sources and technological advancement are vital for ensuring ongoing supply security for lomustine.
FAQs
1. Who are the leading manufacturers of lomustine globally?
The primary manufacturers include Teva Pharmaceuticals, Pfizer via Hospira, and various API producers in India and China, such as Zhejiang Hisun Pharmaceutical and Macleods Pharmaceuticals.
2. Are there licensed generic versions of lomustine available in the United States?
Yes. Teva and other generic manufacturers supply lomustine in the US, with approvals from the FDA ensuring quality and regulatory compliance.
3. How does API sourcing impact lomustine supply stability?
API sourcing from Chinese and Indian manufacturers is a significant determinant of supply stability. Regulatory changes and geopolitical tensions may threaten consistent supply.
4. What are the key challenges facing lomustine suppliers?
Challenges include regulatory compliance, geographic supply disruptions, quality control issues, and increasing demand for diversified supply streams.
5. Will new suppliers emerge for lomustine in the future?
Potentially. As demand persists and patents expire, new entrants, especially in emerging markets, may enter the space, provided they meet strict quality and regulatory standards.
Citations
[1] Legal and regulatory status of lomustine, FDA, EMA databases.
[2] Market reports on generic chemotherapeutic agents, IQVIA.
[3] API manufacturing capabilities and GMP certifications, Zhejiang Hisun Pharmaceutical.
[4] Global API supply chain analyses, PhAMA and Indian Department of Pharmaceuticals.
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