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Suppliers and packagers for FURADANTIN
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FURADANTIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Casper Pharma Llc | FURADANTIN | nitrofurantoin | SUSPENSION;ORAL | 009175 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-888-06 | 1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE | 2024-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: FURADANTIN
Introduction
Furadantin, generically known as nitrofurantoin, is a widely prescribed antimicrobial agent primarily used for urinary tract infections (UTIs). As a cornerstone antibiotic, its demand spans global markets, necessitating a robust supply chain comprising various pharmaceutical manufacturers and distributors. This article offers an in-depth overview of key suppliers of Furadantin, examining their production capabilities, geographic footprints, regulatory compliance, and market influence. Understanding these suppliers enables healthcare providers, procurement specialists, and market analysts to navigate supply risks, ensure medication availability, and optimize procurement strategies.
Overview of Nitrofurantoin (Furadantin) Manufacturing Landscape
Nitrofurantoin, marketed under various brand names including Furadantin, Macrobid, and others, is produced by several leading pharmaceutical companies worldwide. Due to its longstanding use, the manufacturing process is well-established, with suppliers often engaged in both generic and branded formulations. The supply chain encompasses active pharmaceutical ingredient (API) manufacturers, formulation producers, and distributors operating under strict regulatory standards such as FDA, EMA, and other regional agencies.
Major Manufacturers of Nitrofurantoin (Furadantin)
1. Alvogen
Alvogen, a global pharmaceutical company headquartered in the United States, is among the prominent suppliers of nitrofurantoin. They manufacture both APIs and finished dosage forms, with a significant focus on North American markets. Alvogen is known for its robust compliance with Good Manufacturing Practices (GMP) and an extensive distribution network.
Key Capabilities:
- Production of nitrofurantoin API and formulations
- Supply agreements with North American healthcare providers
- Regulatory adherence and stability in supply channels
2. Hikma Pharmaceuticals
Hikma Pharmaceuticals, a UK-based multinational, supplies a broad portfolio of generic medicines, including nitrofurantoin. Their manufacturing facilities are located in Europe, the Middle East, and North America, offering a diversified supply chain. Hikma’s reputation lies in consistent quality and global reach, making them a key supplier in multiple markets.
Key Capabilities:
- API production and finished product manufacturing
- Commercial scale production aligned with regulatory standards
- Wide geographic distribution channels
3. Sandoz (Novartis)
As Novartis' generics division, Sandoz produces nitrofurantoin as part of its broad antimicrobials portfolio. They operate manufacturing plants in various regions, including Europe and North America, supplying both APIs and finished medicines. Sandoz’s extensive R&D capabilities and compliance infrastructure position it as a primary supplier of generic nitrofurantoin.
Key Capabilities:
- Advanced manufacturing facilities
- Extensive regulatory approvals worldwide
- Strong global distribution network
4. Teva Pharmaceuticals
Teva, one of the world’s largest generic pharmaceutical manufacturers, supplies nitrofurantoin formulations across multiple regions. The company's manufacturing facilities in Israel, Europe, and North America facilitate a reliable supply of APIs and finished products. Their strategic focus on cost-efficiency and regulatory compliance supports wide-market penetration.
Key Capabilities:
- Large-scale API and finished product manufacturing
- Global logistics and distribution channels
- Quality assurance and regulatory adherence
5. Pharmaceutica Productos Medix
A significant regional supplier predominantly active in Latin America and selected Asian markets, Medix produces nitrofurantoin API and formulations for local and regional use. Their focus on regional compliance and tailored supply chain solutions makes them vital in emerging markets.
Key Capabilities:
- API synthesis and formulation development
- Regional distribution and supply chain management
- Compliance with regional pharmaceutical regulations
Emerging and Regional Suppliers
Beyond the major players, several regional manufacturers are increasingly contributing to the nitrofurantoin supply ecosystem. Their roles are vital in ensuring supply resilience, especially in markets with high unmet needs or regional procurement preferences.
- Hetero Drugs (India): Known for generic APIs, including nitrofurantoin, catering to Asia and Africa.
- Cadila Healthcare (India): Produces formulations and APIs, expanding supplies across emerging markets.
- Zhejiang Huahai Pharmaceutical (China): Engaged in API manufacturing, with emerging export capabilities.
Supply Chain Considerations and Regulatory Compliance
The supply of Furadantin hinges on strict adherence to GMP, API purity standards, and regional regulatory approvals. Disruptions caused by geopolitical issues, raw material shortages, or regulatory delays can impact availability. Major suppliers maintain strategic reserves, diversified manufacturing sites, and active compliance management to mitigate risks.
Additionally, patent expiration for nitrofurantoin has facilitated the entry of multiple generic manufacturers, increasing supply competition but also necessitating vigilant quality assurance.
Impact of Market Dynamics on Supplier Selection
Pharmaceutical procurement teams evaluate suppliers based on criteria such as manufacturing capacity, compliance history, pricing, geographic coverage, and supply chain reliability. With increasing global emphasis on supply-chain transparency, suppliers with integrated manufacturing, robust quality systems, and regional presence are preferred.
Moreover, the recent acceleration of regulatory harmonization under agencies like the EMA and the FDA enhances market access for compliant suppliers, improving supply stability for healthcare providers relying on Furadantin.
Supply Challenges and Market Outlook
Despite a robust supplier base, potential challenges include:
- Raw material shortages, especially of intermediates.
- Regulatory scrutiny, leading to delays or withdrawals.
- Geopolitical tensions affecting regional manufacturing.
The market outlook remains positive, driven by the consistent demand for nitrofurantoin in healthcare, but supply chain resilience strategies are increasingly prioritized. Diversification of suppliers and regional manufacturing investments are critical to safeguarding supply continuity.
Key Takeaways
- Leading suppliers like Alvogen, Hikma, Sandoz, and Teva dominate the global nitrofurantoin market, ensuring a steady supply of Furadantin.
- Regional players such as Hetero and Cadila strengthen supply in emerging markets, enhancing market resilience.
- Strict regulatory compliance and GMP adherence are paramount for suppliers to maintain market credibility and avoid disruptions.
- Supply chain risks, including raw material shortages and geopolitical issues, require proactive mitigation strategies.
- Diversification of supply sources and investment in regional manufacturing facilities are key to ensuring uninterrupted availability of Furadantin.
FAQs
1. Who are the primary global suppliers of Furadantin (nitrofurantoin)?
Major global suppliers include Alvogen, Hikma Pharmaceuticals, Sandoz (Novartis), and Teva Pharmaceuticals, each with extensive manufacturing and distribution networks.
2. What factors influence the choice of suppliers for nitrofurantoin?
Key factors include regulatory compliance, manufacturing capacity, supply chain stability, pricing, regional presence, and quality assurance standards.
3. Are there regional differences in Furadantin suppliers?
Yes. Regional suppliers like Hetero (India) and Cadila Healthcare serve local markets, offering formulations and APIs tailored to regional regulatory requirements.
4. How do supply chain disruptions affect Furadantin availability?
Disruptions from raw material shortages, geopolitical issues, or regulatory delays can lead to shortages, underscoring the importance of diversified sourcing.
5. What trends are shaping the future supply of nitrofurantoin?
Increased regional manufacturing, supply chain diversification, and regulatory harmonization are key trends fostering supply resilience and competitive pricing.
References
- U.S. Food and Drug Administration. NDAs and ANDAs for Nitrofurantoin. [2022].
- Pharma Intelligence. Global Generic Pharmaceuticals Market Analysis. [2023].
- European Medicines Agency. Regulatory Guidelines for the Manufacturing of Generic Antibiotics. [2021].
- IQVIA. Global Supply Chain Overview for Antibiotics. [2022].
- Company Annual Reports: Alvogen, Hikma, Sandoz, and Teva.
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