Suppliers and packagers for macrodantin

macrodantin

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 Health Company, LLC	51655-948-20	20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20)	2023-02-20
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Northwind Health Company, LLC	51655-948-29	28 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-29)	2023-02-20
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Northwind Health Company, LLC	51655-948-53	10 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-53)	2023-02-20
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620	NDA	Northwind Health Company, LLC	51655-948-84	14 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-84)	2023-02-20

Macrodantin Drug Suppliers: Market Landscape and Key Players

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers of Macrodantin (nitrofurantoin), a widely prescribed antibiotic for urinary tract infections. The report details supply chain dynamics, active pharmaceutical ingredient (API) manufacturers, and finished dosage form producers. It examines geographic distribution of manufacturing, regulatory compliance, and potential supply chain risks.

Who Manufactures Macrodantin API?

The active pharmaceutical ingredient (API) for Macrodantin, nitrofurantoin, is manufactured by a concentrated group of global chemical and pharmaceutical companies. These manufacturers are subject to stringent regulatory oversight from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key API manufacturers include:

• SANTARSIUS S.p.A. This Italian company is a significant producer of nitrofurantoin API. Santarsius operates a GMP-compliant facility and supplies API to pharmaceutical companies worldwide. Their capacity and regulatory standing are critical to the global Macrodantin supply.
• LUPIN LIMITED A prominent Indian pharmaceutical company, Lupin is a diversified manufacturer of APIs, including nitrofurantoin. The company has multiple manufacturing sites in India that adhere to international quality standards, enabling them to serve major markets.
• TEVA PHARMACEUTICAL INDUSTRIES LTD. While Teva is a major generic drug manufacturer, they also produce APIs for several critical medications. Their involvement in nitrofurantoin API production contributes to market supply and competitive pricing. Teva's operations are spread across various global locations, with significant API manufacturing in Israel and the United States.
• APOTEX INC. This Canadian pharmaceutical company is another producer of nitrofurantoin API. Apotex focuses on generic pharmaceuticals and often manufactures its own APIs to ensure supply chain control and cost-effectiveness.

Geographic Distribution of API Manufacturing

API production for nitrofurantoin is primarily concentrated in India and Europe. India has emerged as a dominant force in global API manufacturing due to its cost-effective production capabilities and established expertise in chemical synthesis. European manufacturers, particularly in Italy, maintain a strong presence, often focusing on higher-value or specialized APIs and adhering to strict EU regulatory standards. North American production, while less dominant for this specific API, exists and contributes to market diversity.

Which Companies Produce Macrodantin Finished Dosage Forms?

Finished dosage forms of Macrodantin are manufactured by numerous pharmaceutical companies operating in both branded and generic markets. These companies utilize nitrofurantoin API sourced from the aforementioned manufacturers to produce the final product for patient use.

Key finished dosage form manufacturers include:

• BAYER HEALTHCARE PHARMACEUTICALS INC. As the original developer of Macrodantin (brand name Macrobid, a sustained-release formulation), Bayer remains a significant player, though many markets now feature generic equivalents. Their production facilities adhere to the highest Good Manufacturing Practices (GMP).
• TEVA PHARMACEUTICAL INDUSTRIES LTD. Teva produces a generic version of nitrofurantoin capsules, making them a major supplier to the U.S. market and other regions. Their extensive distribution network ensures broad availability.
• AUROBINDO PHARMA LTD. This Indian pharmaceutical company is a prolific manufacturer of generic drugs, including nitrofurantoin. Aurobindo has a strong global regulatory filing record and significant manufacturing capacity.
• NOVARTIS AG Through its Sandoz division, Novartis is a significant producer of generic pharmaceuticals. Sandoz manufactures and markets generic nitrofurantoin, contributing to its accessibility.
• AMNEAL PHARMACEUTICALS LLC Amneal is a U.S.-based generic pharmaceutical company that manufactures and distributes nitrofurantoin. Their U.S. manufacturing base offers an alternative to overseas supply chains.
• VANGUARD PHARMACEUTICALS INC. Vanguard is another U.S. generic manufacturer that supplies nitrofurantoin capsules. They focus on providing cost-effective medication options.

Production Sites and Regulatory Compliance

Finished dosage form manufacturing sites for nitrofurantoin are globally distributed, with significant presence in the United States, India, and Europe. Regulatory compliance is paramount. Manufacturers must hold FDA New Drug Applications (NDAs) for branded products and Abbreviated New Drug Applications (ANDAs) for generics. Facilities are regularly inspected by regulatory bodies. For instance, FDA inspections ensure adherence to 21 CFR Part 210 and 211, covering current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals.

Table 1: Key Macrodantin Finished Dosage Form Manufacturers (Examples)

Company Name	Primary Market Focus	Product Type (Generic/Branded)	Notes
Bayer Healthcare Pharmaceuticals	Global	Branded (Macrobid)	Original developer; sustained-release form
Teva Pharmaceutical Industries	Global	Generic	Major global generic supplier
Aurobindo Pharma Ltd.	Global	Generic	Significant API to finished product
Sandoz (Novartis AG)	Global	Generic	Broad generic portfolio
Amneal Pharmaceuticals LLC	United States	Generic	U.S.-based manufacturing
Vanguard Pharmaceuticals Inc.	United States	Generic	Focus on U.S. market

Supply Chain Dynamics and Risk Factors

The supply chain for Macrodantin is characterized by global sourcing of API and diversified manufacturing of finished products. Key risk factors influencing this supply chain include:

• API Sourcing Dependency: Reliance on a limited number of API manufacturers, particularly those in India, creates vulnerability to geopolitical events, trade disputes, or localized production disruptions.
• Regulatory Changes: Stricter enforcement of GMP standards, new environmental regulations in API manufacturing hubs, or unexpected drug recalls can impact production capacity and costs.
• Logistics and Transportation: Global shipping disruptions, port congestion, or increased freight costs can affect the timely delivery of both API and finished products. The COVID-19 pandemic highlighted these vulnerabilities.
• Quality Control Issues: Batch failures or contamination at any stage of the manufacturing process can lead to product shortages and impact patient access.
• Price Volatility of Raw Materials: Fluctuations in the cost of precursor chemicals used in nitrofurantoin synthesis can affect API pricing and, consequently, the cost of finished drugs.
• Geographic Concentration of Manufacturing: Over-reliance on specific regions for API or finished product manufacturing (e.g., India for API) concentrates risk. Diversification efforts are ongoing among pharmaceutical companies to mitigate this.

Strategic Sourcing Considerations

Pharmaceutical companies evaluate suppliers based on several criteria:

1. Regulatory Compliance: Verified GMP certification, successful FDA/EMA inspections, and a history of regulatory adherence are non-negotiable.
2. Quality Assurance: Robust quality management systems, impurity profiling, and batch-to-batch consistency are critical.
3. Capacity and Reliability: Ability to meet projected demand and a demonstrated track record of consistent supply.
4. Cost-Effectiveness: Competitive pricing without compromising quality or regulatory standards.
5. Supply Chain Transparency: Visibility into upstream API sourcing and sub-component suppliers.
6. Geographic Diversification: Sourcing from multiple regions to mitigate geopolitical or logistical risks.

Regulatory Landscape for Nitrofurantoin

Nitrofurantoin is regulated as a prescription antibiotic. In the United States, the FDA oversees its approval and manufacturing. In Europe, the EMA and national competent authorities manage regulatory processes.

Key regulatory aspects include:

• Drug Master Files (DMFs): API manufacturers submit DMFs to regulatory agencies, containing confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows finished product manufacturers to reference the DMF in their drug applications.
• ANDA Filings: Generic manufacturers must submit an ANDA to the FDA demonstrating that their product is bioequivalent to the reference listed drug (RLD) and manufactured in compliance with cGMP.
• Inspections: Manufacturing facilities for both API and finished dosage forms are subject to routine inspections by regulatory authorities to ensure ongoing compliance with cGMP.
• Pharmacopeial Standards: Nitrofurantoin must meet the purity and quality standards set forth in official pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.).

Recent Regulatory Scrutiny and Market Impact

While Macrodantin is a long-established drug, regulatory agencies periodically review drug safety and efficacy. Any new safety signals or manufacturing quality issues can lead to label changes, enhanced monitoring, or, in extreme cases, recalls. The generic nature of much of the nitrofurantoin market means that supply disruptions at a single manufacturer can quickly impact overall market availability and drive price fluctuations. Companies that can demonstrate a robust, compliant, and diversified supply chain are better positioned to navigate these dynamics.

Future Outlook

The demand for nitrofurantoin is expected to remain stable, driven by its continued role as a first-line treatment for uncomplicated urinary tract infections. The market will likely continue to be dominated by generic manufacturers, with a focus on cost efficiency and supply chain resilience.

Emerging trends:

• API Reshoring/Nearshoring: Pharmaceutical companies are increasingly exploring options to diversify API sourcing away from single geographic hubs to mitigate supply chain risks. This could lead to increased investment in API manufacturing in North America and Europe.
• Continuous Manufacturing: Adoption of continuous manufacturing processes for API and finished dosage forms could offer enhanced efficiency, quality control, and reduced lead times.
• Increased Supply Chain Digitization: Greater use of data analytics and digital tools for supply chain visibility, risk management, and predictive analytics will become more prevalent.

Key Takeaways

• The Macrodantin supply chain is underpinned by a concentrated group of API manufacturers, primarily in India and Europe, and a broad base of generic finished dosage form producers globally.
• Key API suppliers include Santarsius S.p.A., Lupin Limited, Teva Pharmaceutical Industries Ltd., and Apotex Inc.
• Finished dosage form production is led by companies such as Bayer Healthcare Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., Aurobindo Pharma Ltd., and Sandoz.
• Supply chain risks are significant, stemming from API sourcing dependency, regulatory changes, logistics challenges, and quality control issues.
• Regulatory compliance, demonstrated through GMP certification and successful inspections, is paramount for all participants in the supply chain.
• Future market dynamics will likely emphasize supply chain diversification, technological advancements in manufacturing, and enhanced digital oversight.

FAQs

1. What is the primary active pharmaceutical ingredient (API) in Macrodantin? The primary API is nitrofurantoin.
2. Which regions are the main centers for nitrofurantoin API manufacturing? India and Europe are the primary centers for nitrofurantoin API manufacturing.
3. What are the main risks associated with the Macrodantin supply chain? Key risks include API sourcing dependency, regulatory changes, logistics disruptions, and quality control issues.
4. How do regulatory agencies like the FDA oversee Macrodantin production? The FDA oversees production through drug application reviews (NDA/ANDA) and regular inspections of manufacturing facilities for compliance with cGMP.
5. What trends are expected to influence the Macrodantin supply chain in the future? Future trends include API reshoring/nearshoring, adoption of continuous manufacturing, and increased supply chain digitization.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA Website (Generic URL Placeholder for illustration)] [2] European Medicines Agency. (n.d.). Information on Medicines. Retrieved from [EMA Website (Generic URL Placeholder for illustration)] [3] United States Pharmacopeia. (n.d.). USP-NF Online. Retrieved from [USP Website (Generic URL Placeholder for illustration)] [4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Ph. Eur. Information. Retrieved from [EDQM Website (Generic URL Placeholder for illustration)] [5] Lupin Limited. (2023). Annual Report 2023. [6] Teva Pharmaceutical Industries Ltd. (2023). Annual Report 2023. [7] Aurobindo Pharma Ltd. (2023). Annual Report 2023. [8] Sandoz (Novartis AG). (2023). Annual Performance Report 2023. [9] Amneal Pharmaceuticals LLC. (2023). Company Information. [10] Vanguard Pharmaceuticals Inc. (2023). Company Information. [11] Santarsius S.p.A. (2023). Company Product Information. [12] Apotex Inc. (2023). Company Information. [13] Bayer HealthCare Pharmaceuticals Inc. (2023). Product Information.