Suppliers and packagers for generic pharmaceutical drug: NITROFURANTOIN

NITROFURANTOIN

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.	16571-740-24	1 BOTTLE in 1 CARTON (16571-740-24) / 230 mL in 1 BOTTLE	2020-12-23
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
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175	NDA	Casper Pharma LLC	70199-006-32	1 BOTTLE in 1 CARTON (70199-006-32) / 230 mL in 1 BOTTLE	2020-12-23

Global Landscape of Nitrofurantoin Suppliers: Market Dynamics, Regional Insights, and Strategic Analysis

Nitrofurantoin, a nitrofuran antibiotic primarily used to treat urinary tract infections (UTIs), remains a critical therapeutic agent despite evolving antibiotic resistance patterns. Its unique mechanism of action—conversion by bacterial enzymes into intermediates that disrupt DNA, RNA, and protein synthesis—ensures its relevance as a second-line treatment. This report provides a comprehensive analysis of the global nitrofurantoin supply chain, emphasizing key manufacturers, regional distribution networks, regulatory challenges, and market dynamics.

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Global Nitrofurantoin API Manufacturers and Suppliers

Key Players in Active Pharmaceutical Ingredient Production

The production of nitrofurantoin active pharmaceutical ingredients (APIs) is dominated by established pharmaceutical companies and specialized chemical manufacturers. Rochem International Inc., a U.S.-based distributor with partnerships in China, has been a major supplier since 1994, emphasizing compliance with Good Manufacturing Practices (GMP) and regulatory standards[1][9]. Similarly, Chynops Pharma in India, certified under ISO 9001:2015, provides APIs and advanced intermediates, leveraging cost-effective production capabilities[1][9]. Olpha, a Latvian subsidiary of JSC AB City, combines five decades of pharmaceutical manufacturing expertise with European Union regulatory compliance, positioning itself as a key supplier for Baltic and EU markets[1][2].

In China, Sinoway Industrial Co. Ltd., operational since 1987, offers nitrofurantoin APIs compliant with GMP, USDMF, and ISO 9001:2015 standards. Their one-stop contract development and manufacturing organization (CDMO) services cater to global clients, emphasizing scalability and custom synthesis[12]. Shandong Octagon Chemicals and Shandong Fangxing Technology Development Co Ltd further reinforce China’s role as a hub for API production, with competitive pricing and high-volume output[2][10].

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Regional Supply Chain Dynamics

India: Manufacturing and Franchise Networks

India’s pharmaceutical sector plays a pivotal role in nitrofurantoin production, combining API synthesis with finished-dose formulations. Matins Pharma, a Haryana-based company, markets NEONITRO 100 SR, a sustained-release nitrofurantoin capsule, under a PCD (Propaganda-Cum-Distribution) franchise model. Their WHO/GMP-certified facility emphasizes rapid delivery and high-profit margins for distributors, targeting domestic and South Asian markets[5]. Intas Pharmaceuticals and Macleods Pharmaceuticals supply nitrofurantoin tablets and capsules through wholesalers like Western Medex and Ashtavinayaka Agency, with pricing ranging from ₹126 to ₹802 per strip depending on dosage and packaging[8].

United States: Regulatory Challenges and Market Entrants

The U.S. market has faced intermittent shortages, particularly for oral suspensions. Casper Pharma’s Furadantin® suspension (25 mg/5 mL) has been on backorder since 2025 due to manufacturing delays, while Teva Pharmaceuticals and Amneal have discontinued their generic versions[4]. Conversely, ANI Pharmaceuticals received FDA approval in 2023 for its generic nitrofurantoin oral suspension, capitalizing on the annual $16 million market gap[7]. Nostrum Laboratories and Somerset Therapeutics have emerged as alternative suppliers, though their production capacities remain limited[4].

European Union: Consolidation and Discontinuations

The UK’s dm+d database reflects significant market consolidation, with 21 suppliers of nitrofurantoin 100mg tablets listed as discontinued, including Advanz Pharma, Accord-UK, and Viatris UK[3][6]. This trend underscores broader shifts toward specialized antibiotic production and regulatory pressures on older generics. Duchefa Farma in the Netherlands and Bidachem in Italy maintain API exports, though their finished-product presence has diminished[2][10].

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Market Dynamics and Regulatory Considerations

Supply Shortages and Alternatives

The U.S. shortage of nitrofurantoin oral suspension has necessitated alternative formulations. Pharmacies increasingly compound suspensions using bulk powder and SyrSpend SF PH4 vehicle, a stable 90-day preparation[4]. For enteral administration, Macrodantin capsules (nitrofurantoin macrocrystalline) can be opened and mixed with food, though Macrobid’s monohydrate/macrocrystalline formulation requires intact ingestion due to its modified release mechanism[4][6].

Regulatory Compliance and Certifications

API suppliers must adhere to stringent international standards. Venkatasai Life Sciences and Pharmaffiliates in India prioritize USDMF and CEP certifications to access regulated markets, while Sinoway and TAPI (Teva Active Pharmaceutical Ingredients) emphasize FDA and EMA audits[11][12]. The EU’s Written Confirmation (WC) requirement, mandating GMP equivalence for non-EU manufacturers, has intensified quality control measures for Asian exporters[9][10].

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Competitive Landscape and Strategic Positioning

Major Market Players

• Teva Pharmaceutical Industries: With $16 billion in annual revenue, Teva dominates the generics market, including nitrofurantoin APIs. Its vertical integration—from API production to finished-dose manufacturing—ensures cost efficiency and supply chain resilience[11].
• Pharmaffiliates: Specializing in high-purity APIs, this Indian firm targets niche markets with stringent quality requirements, projecting $50 million in revenue by 2025[11].
• Matins Pharma: Leveraging India’s low production costs, Matins offers competitive pricing for sustained-release formulations, capturing emerging markets in Africa and Southeast Asia[5].

Emerging Trends

1. CDMO Expansion: Companies like Sinoway and Rochem are diversifying into contract development, offering end-to-end solutions from API synthesis to packaging[12][1].
2. Geographic Diversification: Chinese manufacturers are expanding into Latin America and the Middle East, bypassing traditional EU/U.S. markets amid trade restrictions[10][12].
3. Biopharma Partnerships: Collaborations between API suppliers and biotech firms aim to develop nitrofarans with enhanced bioavailability and reduced resistance[11].

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Future Outlook and Recommendations

The nitrofurantoin market is poised for growth, driven by rising UTI prevalence and antibiotic stewardship programs favoring narrow-spectrum agents. However, suppliers must address:

• Quality Consistency: Invest in advanced analytics for real-time batch monitoring to prevent recalls.
• Regulatory Agility: Pre-empt certifications for emerging markets (e.g., Africa’s AMA) to expedite market entry.
• Sustainability: Adopt green chemistry principles in API synthesis to reduce environmental impact and comply with ESG criteria.

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Key Takeaways

• Asia-Pacific dominates API production, while North America and Europe face formulation shortages.
• Regulatory compliance remains a critical differentiator in supplier selection.
• Strategic partnerships and geographic diversification will define market leadership.

FAQs

1. Why are nitrofurantoin oral suspensions frequently in shortage?
   Manufacturing complexities and regulatory delays, as seen with Casper Pharma, disrupt supply chains[4][7].
2. How do Indian suppliers maintain competitive pricing?
   Leveraging low labor costs, vertical integration, and government subsidies for API production[5][8].
3. What certifications are essential for EU market access?
   Written Confirmation (WC), CEP, and compliance with EMA GMP standards[9][10].
4. Can nitrofurantoin capsules be used for enteral feeding?
   Only macrocrystalline capsules (e.g., Macrodantin) are suitable; modified-release forms like Macrobid require intact ingestion[4][6].
5. Which companies lead in sustained-release formulations?
   Matins Pharma (NEONITRO 100 SR) and Intas Pharmaceuticals (Niftagen-SR) dominate this niche[5][8].

"The future of nitrofurantoin supply lies in balancing cost efficiency with uncompromising quality, ensuring access to this critical antibiotic remains uninterrupted." – Industry Analyst, PharmaCompass [1][9]

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/nitrofurantoin
2. https://pharmaoffer.com/api-excipient-supplier/antibacterials/nitrofurantoin
3. https://dmd-browser.nhsbsa.nhs.uk/vmp/view/1852/suppliers
4. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=433
5. https://matinspharma.com/our-products/nitrofurantoin-sr-manufacturer-supplier-in-pcd-pharma-franchise/
6. https://dmd-browser.nhsbsa.nhs.uk/vmp/view/1828/suppliers
7. https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-fda-approval-and-launch-1
8. https://dir.indiamart.com/impcat/nitrofurantoin.html?biz=30
9. https://www.pharmacompass.com/manufacturers-suppliers-exporters/nitrofurantoin
10. https://pharmaoffer.com/api-excipient-supplier/antibacterials/nitrofurantoine
11. https://github.com/jaspartatin/Market-Research-Report-List-1/blob/main/nitrofurantoin-api-market-global-outlook-and-forecast-2022-2028-market.md
12. https://pharmaoffer.com/api-excipient-supplier/company/sinoway-industrial-co-ltd/product/nitrofurantoin