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.	16571-888-06	1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE	2024-02-01
Amneal Pharms	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	201679	ANDA	Amneal Pharmaceuticals LLC	65162-689-88	230 mL in 1 BOTTLE, GLASS (65162-689-88)	2011-03-24
Amneal Pharms	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	201679	ANDA	Amneal Pharmaceuticals NY LLC	69238-2512-9	1 BOTTLE, GLASS in 1 CARTON (69238-2512-9) / 230 mL in 1 BOTTLE, GLASS	2021-05-31
Annora Pharma	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	219495	ANDA	Camber Pharmaceuticals, Inc.	31722-491-23	1 BOTTLE in 1 CARTON (31722-491-23) / 230 mL in 1 BOTTLE	2025-07-02
Aurobindo Pharma	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	212607	ANDA	Aurobindo Pharma Limited	59651-206-23	1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE	2023-05-11
Aurobindo Pharma	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	212607	ANDA	Rising Pharma Holdings, Inc.	64980-593-24	1 BOTTLE in 1 CARTON (64980-593-24) / 230 mL in 1 BOTTLE	2023-05-11
Biocon Pharma	NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	218346	ANDA	Biocon Pharma Inc	70377-118-31	1 BOTTLE, GLASS in 1 CARTON (70377-118-31) / 230 mL in 1 BOTTLE, GLASS	2024-11-15

Nitrofurantoin Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes key suppliers for the pharmaceutical active pharmaceutical ingredient (API) nitrofurantoin. It identifies major manufacturers, their production capacities where available, regulatory approvals, and potential supply chain risks. The analysis focuses on entities that hold significant market share or possess unique manufacturing capabilities.

Who are the Primary Manufacturers of Nitrofurantoin API?

The global supply of nitrofurantoin API is concentrated among a limited number of manufacturers. Key players identified include both established pharmaceutical ingredient producers and specialized chemical manufacturers.

• Sintetica S.A. (Switzerland) is a significant manufacturer. Sintetica has a long history of API production and operates multiple cGMP (current Good Manufacturing Practices) compliant facilities. Their product portfolio includes various controlled substances and complex APIs, indicating robust quality control and regulatory adherence.
• Teva Pharmaceutical Industries Ltd. (Israel) is a major global pharmaceutical company with a substantial API manufacturing arm. Teva produces a wide range of APIs, including nitrofurantoin, serving both its internal finished dosage form needs and the external market. Teva's global manufacturing footprint provides a degree of supply chain resilience.
• Divi's Laboratories Limited (India) is a prominent custom synthesis and API manufacturer. Divi's is known for its large-scale production capabilities and has multiple FDA-approved manufacturing sites. Their extensive experience in complex chemical synthesis makes them a critical supplier for many APIs.
• Cadila Healthcare Ltd. (Zydus Cadila) (India) is another significant Indian pharmaceutical company with strong API manufacturing operations. Zydus Cadila is involved in the production of various therapeutic categories and adheres to international regulatory standards, including US FDA and EMA compliance.
• Caplin Point Laboratories Ltd. (India) manufactures and supplies APIs, particularly for emerging markets. While their specific nitrofurantoin capacity is not publicly detailed, they are a recognized supplier in the broader API landscape.

What is the Regulatory Status of Key Nitrofurantoin Suppliers?

Regulatory compliance is paramount for API suppliers. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are key regulatory bodies whose inspections and approvals are critical indicators of supplier reliability and product quality.

• Sintetica S.A.: Operates facilities that are regularly inspected by major regulatory authorities. Their website indicates compliance with US FDA, EMA, and Swissmedic regulations. Specific inspection dates and outcomes are generally proprietary but their long-standing market presence suggests a history of satisfactory compliance.
• Teva Pharmaceutical Industries Ltd.: Teva's numerous manufacturing sites worldwide are subject to frequent inspections by global regulatory bodies, including the FDA. Many of Teva's facilities have a history of successful FDA inspections. For instance, their plant in Irvine, California, and facilities in Europe and Israel have undergone FDA scrutiny.
• Divi's Laboratories Limited: Divi's has multiple FDA-approved manufacturing sites in India. These sites are regularly inspected by the FDA. Recent inspection reports are publicly accessible through FDA databases, though specific details on individual API production lines may be confidential. Divi's has also received approvals from other regulatory bodies like EMA.
• Cadila Healthcare Ltd. (Zydus Cadila): Zydus Cadila's API manufacturing facilities in India are approved by the US FDA and are subject to regular inspections. They also hold approvals from the EMA and other international regulatory agencies. Their Ankleshwar facility, for example, is a significant API production site.
• Caplin Point Laboratories Ltd.: Caplin Point's facilities are approved by various regulatory authorities, including those in regulated markets. Their API manufacturing sites in India comply with cGMP standards and have been inspected by regulatory agencies.

What are the Production Capacities and Market Share Estimates?

Precise, up-to-date global production capacities for individual APIs like nitrofurantoin are often not publicly disclosed by manufacturers due to competitive sensitivities. However, market share can be inferred from the volume of exports, participation in tender processes, and the presence of their APIs in finished drug products.

• India and China: These countries are the dominant global producers of many APIs, including nitrofurantoin. Manufacturers in these regions often benefit from lower production costs and established chemical synthesis infrastructure. Companies like Divi's Laboratories and Zydus Cadila are major contributors from India. Chinese manufacturers, though less explicitly named in this analysis due to a broader and more fragmented supplier base, collectively hold a significant share.
• European Manufacturers: Companies like Sintetica S.A. represent a smaller but critical segment of the supply chain, often focusing on higher-value or more complex APIs and maintaining stringent quality standards.
• Israeli Manufacturers: Teva Pharmaceutical Industries, with its integrated model, plays a role in both API production and finished product manufacturing, influencing overall market dynamics.

Estimates of market share are difficult to quantify precisely without proprietary market research data. However, based on the scale of operations and stated focus, Divi's Laboratories and Teva are likely to hold substantial portions of the global nitrofurantoin API market. Indian suppliers, in general, are estimated to account for over 40% of global API exports.

What are the Potential Supply Chain Risks for Nitrofurantoin?

The nitrofurantoin supply chain, like many in the pharmaceutical industry, faces several potential risks that could impact availability and pricing.

• Geopolitical Instability: Concentration of manufacturing in specific regions, particularly India and China, makes the supply chain vulnerable to regional conflicts, trade disputes, or government-imposed export restrictions. For example, any significant trade barriers imposed by India or China could disrupt global supply.
• Regulatory Scrutiny and Inspections: Findings of non-compliance during FDA or EMA inspections can lead to manufacturing shutdowns or product recalls, directly impacting supply. A prolonged FDA warning letter to a key nitrofurantoin manufacturer could create immediate shortages.
• Raw Material Sourcing: The synthesis of nitrofurantoin relies on specific precursor chemicals. Disruptions in the supply of these raw materials, whether due to manufacturing issues, environmental regulations, or other supply chain interruptions, can halt API production. For instance, a shortage of a key starting material like 5-nitro-2-furaldehyde could halt nitrofurantoin synthesis.
• Natural Disasters and Environmental Factors: Extreme weather events or natural disasters in manufacturing regions can damage facilities or disrupt logistics. Environmental regulations are also becoming more stringent in many API-producing countries, potentially impacting production costs or requiring facility upgrades.
• Quality Control Failures: Any deviation from cGMP standards, leading to out-of-specification batches or contamination, can result in product rejection, recalls, and loss of customer trust. This directly impacts the availability of API for finished drug products.
• Intellectual Property and Patent Landscape: While nitrofurantoin itself is an older drug with expired patents, process patents for improved synthesis methods or novel polymorphic forms could still influence market access or production costs for certain manufacturers. A new patent challenging an existing manufacturing route could create disruptions for non-infringers.
• Currency Fluctuations and Economic Factors: Changes in exchange rates and overall economic conditions in major producing countries can affect the cost of production and global pricing strategies. A significant depreciation of the Indian Rupee, for example, could make Indian APIs more competitive but also impact profit margins for manufacturers if input costs rise.

How can Pharmaceutical Companies Mitigate Supply Chain Risks?

To ensure a consistent supply of nitrofurantoin API and minimize disruptions, pharmaceutical companies should implement a multi-faceted risk mitigation strategy.

• Diversify Supplier Base: Engaging with multiple qualified suppliers across different geographical regions reduces reliance on any single entity or country. Establishing relationships with at least two to three cGMP-compliant manufacturers, ideally in distinct regions (e.g., India and Europe), is a primary strategy.
• Dual Sourcing and Inventory Management: Maintaining strategic safety stocks of critical raw materials and finished API can buffer against short-term supply disruptions. This requires careful forecasting and warehousing capabilities, balancing inventory costs against the risk of stock-outs.
• Supplier Audits and Qualification: Conducting rigorous and regular audits of potential and existing suppliers is essential to ensure ongoing compliance with quality and regulatory standards. These audits should extend beyond initial qualification to include process controls and environmental monitoring.
• Contingency Planning and Business Continuity: Developing detailed contingency plans for various risk scenarios, including natural disasters, geopolitical events, or major quality failures, allows for a swift and organized response. This includes identifying alternative logistics providers and backup manufacturing sites if feasible.
• Long-Term Contracts and Partnerships: Securing long-term supply agreements with key manufacturers can provide price stability and guaranteed allocation, especially during periods of high demand or supply constraints. Building strong, collaborative relationships with suppliers can also lead to early notification of potential issues.
• Regulatory Monitoring: Proactively monitoring regulatory changes and inspection outcomes for key suppliers is crucial. This allows for early identification of potential compliance issues that could lead to supply interruptions.

Key Takeaways

The global supply of nitrofurantoin API is concentrated, with significant production capabilities residing in India and major pharmaceutical companies like Teva. Regulatory compliance is a critical factor, with US FDA and EMA approvals being essential for market access. Supply chain risks include geopolitical instability, regulatory actions, raw material shortages, and quality control failures. Mitigation strategies should focus on supplier diversification, robust inventory management, thorough supplier qualification, and proactive contingency planning.

Frequently Asked Questions

What are the primary geographical regions for nitrofurantoin API manufacturing?

India and China are the dominant global manufacturing hubs for nitrofurantoin API due to cost advantages and established chemical synthesis infrastructure.

How often are API manufacturing facilities inspected by regulatory bodies?

Frequency of inspections varies. For example, US FDA inspections of facilities supplying the US market can range from annually to every few years, depending on the facility's compliance history and risk profile.

What is the typical lead time for ordering nitrofurantoin API?

Lead times can vary significantly based on the supplier's current production schedule, batch sizes, and shipping logistics. Generally, lead times can range from 8 to 16 weeks for established orders, but may be longer for new suppliers or during periods of high demand.

Are there any readily available substitutes for nitrofurantoin API in generic drug formulations?

Nitrofurantoin is a specific chemical entity, and for generic formulations to be bioequivalent, they must use the same API. There are no direct chemical substitutes for nitrofurantoin API itself within the same therapeutic class for treating urinary tract infections.

What are the quality control standards for nitrofurantoin API?

Nitrofurantoin API must meet stringent quality control standards as defined by pharmacopoeias such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). These standards cover aspects like purity, impurity profiles, assay, and physical characteristics.

Citations

[1] Sintetica S.A. (n.d.). API Manufacturing. Retrieved from [website of Sintetica S.A.]

[2] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [website of Teva Pharmaceutical Industries Ltd.]

[3] Divi's Laboratories Limited. (n.d.). APIs. Retrieved from [website of Divi's Laboratories Limited]

[4] Cadila Healthcare Ltd. (Zydus Cadila). (n.d.). API Manufacturing. Retrieved from [website of Zydus Cadila]

[5] Caplin Point Laboratories Ltd. (n.d.). API Business. Retrieved from [website of Caplin Point Laboratories Ltd.]

[6] U.S. Food & Drug Administration. (n.d.). FDA Drug Master Files (DMFs). Retrieved from [FDA website for DMF information]

[7] European Medicines Agency. (n.d.). Active Substance Master Files (ASMFs). Retrieved from [EMA website for ASMF information]