Suppliers and packagers for generic pharmaceutical drug: NITROFURANTOIN, MACROCRYSTALLINE

NITROFURANTOIN, MACROCRYSTALLINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Alvogen Inc.	47781-306-01	100 CAPSULE in 1 BOTTLE, PLASTIC (47781-306-01)	2010-09-27
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Alvogen Inc.	47781-307-01	100 CAPSULE in 1 BOTTLE, PLASTIC (47781-307-01)	2010-09-27
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Alvogen Inc.	47781-308-01	100 CAPSULE in 1 BOTTLE, PLASTIC (47781-308-01)	2010-09-27
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Northwind Pharmaceuticals, LLC	51655-948-20	20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20)	2023-02-20

Suppliers for the Pharmaceutical Drug: Nitrofurantoin, Macrocrystalline

Last updated: July 29, 2025

Introduction

Nitrofurantoin, especially in its macrocrystalline form, is a critical antimicrobial agent widely prescribed for uncomplicated urinary tract infections (UTIs). Its unique pharmacokinetic profile, owing to the macrocrystalline formulation, ensures prolonged drug release, making it effective for sustained bacterial eradication. The global supply chain for macrocrystalline nitrofurantoin involves various pharmaceutical manufacturers, wholesalers, and distributors. This review offers an in-depth analysis of current suppliers, assessing their market positions, regulatory compliance, manufacturing capabilities, and potential risks to stakeholders.

Market Overview of Macrocrystalline Nitrofurantoin

Macrocrystalline nitrofurantoin has been a staple in antimicrobial therapy since the 1950s. Its stability and sustained-release properties have cemented its utility in outpatient settings. The demand maintains steady, driven by endemic urinary tract infections and antimicrobial stewardship programs aimed at reducing resistance. Key regions include North America, Europe, and parts of Asia. Ongoing genericization has increased supplier diversity but also intensified competition.

Leading Suppliers in the Global Market

1. Par Pharmaceutical (USA)
   A prominent generic manufacturer, Par Pharmaceutical holds several U.S. drug approvals for macrocrystalline nitrofurantoin. Their manufacturing facilities comply with cGMP standards and are approved by the FDA, enabling a reliable supply chain for North American markets. Par’s extensive distribution network and strategic partnerships bolster its market presence.

2. Teva Pharmaceuticals (Israel)
   As one of the world's largest generic pharmaceutical companies, Teva supplies macrocrystalline nitrofurantoin to multiple global markets. Their manufacturing facilities adhere to international quality standards, and Teva’s extensive portfolio affords it significant capacity for production scale-up, ensuring robustness in supply.

3. Mylan (Part of Viatris)
   Mylan, now integrated within Viatris, produces macrocrystalline nitrofurantoin through its well-established manufacturing sites in Europe and the Middle East. The company emphasizes high-quality standards and regulatory compliance, enabling it to meet the demands of various regulatory authorities and maintain consistent supply.

4. Pfizer
   Pfizer’s generics division supplies macrocrystalline nitrofurantoin across various regions, notably Europe. Pfizer’s global operational scope ensures quality assurance and the ability to meet fluctuating market demands.

5. Sandoz (Novartis)
   Sandoz is a key North American and European supplier with multiple formulations of nitrofurantoin, including macrocrystalline variants. Their focus on biosimilar and small-molecule drugs enables a competitive stance in the antimicrobial market.

6. Aurobindo Pharma
   An emerging Indian pharmaceutical player, Aurobindo supplies macrocrystalline nitrofurantoin primarily to Asian markets but is expanding globally. Their compliance with international quality standards supports their competitiveness.

7. Lupin Limited
   Another prominent Indian manufacturer, Lupin, maintains a robust portfolio of generic antibiotics, including macrocrystalline nitrofurantoin, with a focus on quality and affordability.

Regulatory and Quality Standards

Suppliers must adhere to cGMP (current Good Manufacturing Practices) and obtain approvals from respective regulatory bodies such as the FDA (United States), EMA (Europe), and CDSCO (India). These standards ensure product purity, stability, and bioequivalence. Many suppliers also conduct stability testing and have batch release protocols aligned with international regulatory guidelines.

Supply Chain Considerations

While major players like Teva and Pfizer provide reliable supplies, supply chain disruptions may arise from geopolitical factors, regulatory delays, raw material shortages, or manufacturing site issues. The COVID-19 pandemic revealed vulnerabilities in global supply chains, prompting many stakeholders to diversify sources and increase inventory buffers.

Emerging Trends in Supplier Landscape

• Geographical Diversification: The shift towards Asian manufacturers, particularly India and China, has increased capacity but introduces quality control challenges. Many buyers prioritize suppliers with established regulatory compliance and robust quality assurance programs.
• Regulatory Harmonization: Companies investing in harmonizing manufacturing standards across markets reduce compliance risks and streamline approvals.
• Sustainability Initiatives: Suppliers emphasizing environmentally sustainable manufacturing practices are gaining favor, aligning with global standards like WHO’s Good Practices in Manufacturing.

Assessing Supplier Risks and Opportunities

• Quality Assurance: Ensuring suppliers meet stringent regulatory standards is paramount for drug safety and efficacy.
• Capacity Flexibility: Suppliers capable of scaling production swiftly are better positioned to meet unpredictable demands.
• Pricing and Accessibility: Cost-effective suppliers can influence formulary inclusion and patient access.
• Market Competition: The proliferation of generic manufacturers fosters price competition but may compromise supply stability if not managed properly.

Conclusion

The macrocrystalline form of nitrofurantoin is supplied by a diverse set of manufacturers primarily located in North America, Europe, and Asia. Leading suppliers like Par Pharmaceutical, Teva, Mylan (Viatris), Pfizer, and Sandoz provide a stable source for global markets, with quality and regulatory compliance as fundamental selection criteria. The expanding Asian manufacturing base offers increased capacity but necessitates rigorous quality oversight. As the demand for nitrofurantoin persists, stakeholders should monitor supply chain dynamics, regulatory developments, and emerging manufacturers to ensure consistent availability and quality.

---

Key Takeaways

• Multiple global suppliers, notably Teva, Pfizer, Mylan, and Sandoz, dominate the macrocrystalline nitrofurantoin market, ensuring widespread access.
• Regulatory compliance with cGMP standards remains critical for supplier reliability; buyers must verify certifications and batch records.
• Geographical diversification, especially involving Indian manufacturers, expands capacity but requires strict quality oversight.
• Supply chain resilience can be enhanced through supplier diversification, strategic inventory management, and monitoring geopolitical risks.
• Emphasizing sustainable manufacturing practices may become a differentiator among suppliers moving forward.

---

FAQs

1. Who are the top suppliers of macrocrystalline nitrofurantoin globally?
   Major suppliers include Teva Pharmaceuticals, Pfizer, Mylan (Viatris), Sandoz, and Par Pharmaceutical, with additional regional players in India and China.

2. What regulatory standards should suppliers of macrocrystalline nitrofurantoin meet?
   Suppliers must comply with cGMP standards approved by relevant authorities such as FDA, EMA, and CDSCO, ensuring product quality, safety, and efficacy.

3. Are there regional differences in available suppliers for macrocrystalline nitrofurantoin?
   Yes. North America and Europe predominantly source from Western pharmaceutical giants, while India and China host a growing number of regional manufacturers expanding globally.

4. How can pharmaceutical companies mitigate supply disruptions for nitrofurantoin?
   By diversifying suppliers, maintaining strategic stockpiles, conducting rigorous supplier audits, and engaging with manufacturers adhering to international quality standards.

5. What future trends may influence the supply landscape of macrocrystalline nitrofurantoin?
   An increased focus on quality assurance, sustainability, regulatory harmonization, and the entry of new manufacturers in emerging markets will shape future supply dynamics.

---

References

1. [1] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." (2023).
2. [2] European Medicines Agency. "Guidelines on Good Manufacturing Practice." (2022).
3. [3] GlobalData. "Pharmaceutical Market Analysis: Antibiotics." (2023).
4. [4] Indian Pharmacopoeia Commission. "Schedule M — Manufacturing Process and Standards." (2022).
5. [5] WHO. "Good Practices in Manufacturing of Active Pharmaceutical Ingredients." (2020).