The global pharmaceutical industry continues to face a significant challenge in managing urinary tract infections (UTIs), which affect millions of patients annually. As an essential antibiotic in the nitrofuran class, Nitrofurantoin remains a frontline treatment due to its high efficacy and low resistance rates. For pharmaceutical formulators, identifying a reliable Nitrofurantoin API manufacturer is critical to ensuring the final product’s safety, stability, and therapeutic performance.
At Chemox Pharma, we take pride in being a leading Nitrofurantoin API manufacturer, providing high-purity ingredients that meet the most stringent international quality standards. Our state-of-the-art manufacturing facility in Dahej, Gujarat, is designed to deliver consistent quality and regulatory compliance for global markets.
What is Nitrofurantoin API?
Nitrofurantoin (CAS No. 67-20-9) is a synthetic nitrofuran derivative with antibacterial properties. Unlike many broad-spectrum antibiotics, Nitrofurantoin is specifically concentrated in the urine, making it exceptionally effective for treating uncomplicated UTIs. It works by inhibiting several bacterial enzyme systems, including DNA and RNA synthesis, protein synthesis, and aerobic energy metabolism.
Key Specifications of Nitrofurantoin API
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Feature
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Details
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Chemical Name
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1-[(5-nitro-2-furyl)methyleneamino]hydantoin
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CAS Number
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67-20-9
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Molecular Formula
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C₈H₆N₄O₅
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Molecular Weight
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238.16 g/mol
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Regulatory Grades
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IP / BP / EP / USP
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Therapeutic Class
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Antibiotic / Anti-Bacterial (UTI Specific)
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Appearance
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Yellow crystalline powder
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Why Choose Chemox Pharma as Your Nitrofurantoin API Manufacturer?
Selecting the right Nitrofurantoin API manufacturer involves evaluating more than just the product price. It requires a partner who understands the complexities of chemical synthesis and the importance of regulatory documentation.
1. WHO-GMP Certified Production
Our manufacturing facility in the Dahej Industrial Estate operates under strict WHO-GMP guidelines. We utilize advanced technology and rigorous quality control measures to ensure that every batch of Nitrofurantoin API meets the highest purity standards, typically exceeding 99%.
2. Comprehensive Regulatory Support
We understand that navigating global regulatory landscapes can be challenging. As a dedicated Nitrofurantoin API manufacturer, we provide extensive support, including Drug Master File (DMF) filings and complete documentation for IP, BP, EP, and USP grades. This ensures a smooth approval process for your finished dosage forms in various international markets.
3. Diverse Product Forms
Nitrofurantoin is often required in different physical forms to suit various formulation needs. Chemox Pharma offers:
- Nitrofurantoin Anhydrous: Ideal for standard tablet and capsule formulations.
- Nitrofurantoin Monohydrate: Often used in combination with macrocrystals for sustained-release formulations.
- Nitrofurantoin Macrocrystals: Specifically engineered for better gastrointestinal tolerance and controlled absorption.
4. Strategic Location and Supply Chain
Located in Gujarat, the pharmaceutical hub of India, Chemox Pharma benefits from excellent logistics and a robust supply chain. This allows us to offer competitive pricing and ensure timely delivery to our partners in over 90 countries.
The Therapeutic Importance of Nitrofurantoin
Nitrofurantoin is recognized by the World Health Organization (WHO) as an essential medicine. Its unique mechanism of action makes it less prone to the development of bacterial resistance compared to other antibiotics like fluoroquinolones or sulfonamides. This longevity in clinical use reinforces the need for a high-quality Nitrofurantoin API manufacturer who can maintain the integrity of the molecule through advanced synthesis processes.
Applications in Pharmaceutical Formulations:
- Immediate-Release Capsules: Utilizing Nitrofurantoin macrocrystals for acute UTI treatment.
- Sustained-Release Tablets: Combining monohydrate and macrocrystals for twice-daily dosing.
- Oral Suspensions: For pediatric use or patients with difficulty swallowing solid dosages.
Conclusion
As the demand for effective UTI treatments grows, partnering with a trusted Nitrofurantoin API manufacturer becomes a strategic advantage for pharmaceutical companies. Chemox Pharma combines scientific expertise with a commitment to quality, ensuring that our partners receive the best possible ingredients for their formulations.
Whether you are looking for Nitrofurantoin Anhydrous, Monohydrate, or Macrocrystals, our team is ready to support your requirements with high-purity APIs and comprehensive regulatory assistance.
