Bulk Pharmaceutical API Sources for NITROFURANTOIN MACROCRYSTALLINE

Bulk Pharmaceutical API Sources for NITROFURANTOIN MACROCRYSTALLINE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5492202
Sigma-Aldrich		N7878_SIGMA
Molport		MolPort-001-018-217
AKos Consulting & Solutions		AKOS001678301
Vitas-M Laboratory		STK009471

Bulk Active Pharmaceutical Ingredient (API) Sources for: NITROFURANTOIN MACROCRYSTALLINE

Last updated: August 12, 2025

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Introduction

Nitrofurantoin macrocrystalline is a widely used broad-spectrum antibiotic primarily indicated for urinary tract infections (UTIs). Its efficacy hinges on the purity, stability, and consistent supply of high-quality active pharmaceutical ingredients (APIs). With the increasing global demand for antibiotics and the critical need for supply chain robustness, identifying reputable sources for bulk nitrofurantoin macrocrystalline API has become a priority for pharmaceutical companies, contract manufacturing organizations (CMOs), and regulatory agencies.

This review delineates key API manufacturers, highlights sourcing considerations, and discusses compliance and quality standards vital for procurement of bulk nitrofurantoin macrocrystalline.

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Global API Manufacturers and Suppliers

Several reputable organizations globally manufacture and supply nitrofurantoin macrocrystalline API, operating under stringent quality standards such as Good Manufacturing Practice (GMP). These companies are distinguished by their advanced synthesis capabilities, rigorous quality control, and supply stability.

1. Piramal Pharma Solutions

Piramal Pharma Solutions is a leading pharmaceutical CDMO with extensive experience in synthesizing nitrofurantoin APIs. Their manufacturing facilities in India adhere to the most rigorous GMP standards, ensuring high purity and batch-to-batch consistency. Piramal offers both bulk active ingredients and custom synthesis options tailored to client specifications.

2. Jiangsu Hengrui Medicine Co., Ltd.

A prominent Chinese pharmaceutical producer, Jiangsu Hengrui has established a reputation for producing high-quality antibiotics, including nitrofurantoin macrocrystalline. Their facilities comply with Chinese GMP and international standards, with certifications suitable for export markets. Hengrui’s scalable manufacturing capacity ensures reliable supply.

3. Zhejiang HKF Pharmaceutical Co., Ltd.

This Chinese API manufacturer has invested significantly in GMP-compliant production lines for nitrofurantoin. Their API products are known for high purity, stability, and compliance with major pharmacopeial standards. The company has an extensive distribution network across Asia, Europe, and North America.

4. Zhejiang Lihua Pharmaceutical Co., Ltd.

Specialized in antibiotics, Zhejiang Lihua supplies nitrofurantoin macrocrystalline API globally. Their manufacturing processes incorporate advanced purification techniques, ensuring the API’s quality and consistency. Lihua's API meets strict pharmacopeial specifications, serving both generic and branded formulations.

5. Mersochem Ltd.

Based in India, Mersochem supplies a range of antibiotic APIs, including nitrofurantoin macrocrystalline, with a focus on quality and regulatory compliance. Their facilities operate under GMP, and they frequently supply APIs for both domestic and international markets.

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Quality and Regulatory Considerations

When sourcing nitrofurantoin macrocrystalline API, critical aspects include:

• GMP compliance: Ensures the API production adheres to international quality standards, reducing risk of impurities and contamination.
• Certifications: Certificates of Analysis (CoA), Certificate of Origin, ISO certifications, and relevant pharmacopeial compliance (USP, EP, JP) are essential.
• Purity standards: The API should meet or exceed the typical purity specifications (>98%) with low levels of residual solvents, heavy metals, and related impurities.
• Supply stability: Established relationships with manufacturers that demonstrate consistent production capacity and reliable logistics.
• Audit and qualification processes: Facilities should permit audit visits and provide comprehensive documentation to support due diligence.

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Challenges and Considerations in API Sourcing

• Traceability and Transparency: Ensuring full traceability of the API from raw material to final batch.
• Price Variability: API costs fluctuate based on raw material availability, manufacturing complexity, and geopolitical stability.
• Regulatory Approval: Ensuring the API supplier’s quality meets regulatory requirements for markets where the final product is marketed.
• Intellectual Property: Confirming there are no patent restrictions or licensing issues when sourcing from particular manufacturers.

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Emerging Trends and Innovations

• Synthetic Process Optimization: Manufacturers are investing in novel synthesis routes to improve yield and reduce impurities.
• Green Chemistry Practices: Emphasis on environmentally sustainable manufacturing processes to meet global ESG standards.
• Supply Chain Diversification: Companies are increasingly engaging multiple suppliers to mitigate risks associated with single-source dependency.

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Conclusion

Sourcing high-quality bulk nitrofurantoin macrocrystalline API involves selecting reliable manufacturers that comply with international quality standards. Leading producers such as Piramal Pharma Solutions, Jiangsu Hengrui Medicine, and Zhejiang-based companies offer proven products with rigorous quality control. Organizations should prioritize GMP compliance, transparency, and supply stability to ensure the API’s suitability for manufacturing safe and effective pharmaceutical products.

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Key Takeaways

• Quality is Paramount: Prioritize GMP-compliant manufacturers with comprehensive certifications and quality documentation.
• Diversify Suppliers: Engage multiple suppliers to mitigate supply chain disruptions.
• Regulatory Alignment: Ensure APIs meet pharmacopeial standards relevant to the target markets.
• Due Diligence: Conduct regular audits and review Certificates of Analysis to verify quality and consistency.
• Innovate and Adapt: Stay informed about new synthetic methods and sustainable manufacturing practices to future-proof sourcing strategies.

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FAQs

1. What are the main criteria for selecting an API supplier for nitrofurantoin?
Quality compliance (GMP), certifications, purity standards, supply reliability, manufacturing capacity, and regulatory alignment.

2. Are Chinese API manufacturers reliable for sourcing nitrofurantoin macrocrystalline?
Yes. Many Chinese manufacturers, such as Jiangsu Hengrui, Zhejiang Lihua, and Zhejiang HKF, meet rigorous GMP standards and supply globally with high-quality APIs.

3. How does manufacturing process affect API quality?
Advanced synthesis and purification techniques reduce impurity levels, enhance stability, and improve batch consistency, directly impacting drug safety and efficacy.

4. What are typical purity requirements for nitrofurantoin APIs?
Standards typically require >98% purity, with low residual solvents, heavy metals, and absence of harmful impurities.

5. Is supply chain diversification necessary when sourcing APIs?
Yes. Engaging multiple reputable suppliers minimizes risks associated with geopolitical, manufacturing, or logistical disruptions.

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References

1. [1] U.S. Pharmacopeia. "Nitrofurantoin Monograph." USP-NF, 2022.
2. [2] European Pharmacopoeia. "Nitrofurantoin Monograph," EP, 2022.
3. [3] WHO Essential Medicines. "Nitrofurantoin," WHO, 2021.
4. [4] Industry reports and manufacturer disclosures, accessed 2023.