Bulk Pharmaceutical API Sources for NITROFURAZONE

Bulk Pharmaceutical API Sources for NITROFURAZONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		73340_ALDRICH
TCI (Tokyo Chemical Industry)		N0200
Molport		MolPort-000-886-370
Hangzhou APIChem Technology		AC-10331
AKos Consulting & Solutions		AKOS000304771
Vitas-M Laboratory		STK741625
TimTec		SBB028409

Bulk Active Pharmaceutical Ingredient (API) Sources for NITROFURAZONE

Last updated: August 2, 2025

Introduction

Nitrofurazone, a broad-spectrum topical antimicrobial, is predominantly used for wound management, burns, and skin infections. Its efficacy derives from its active ingredient, nitrofurazone, a nitrofuran derivative with bactericidal and bacteriostatic properties. As demand for topical antibiotics persists, the sourcing of high-quality bulk APIs becomes vital for pharmaceutical manufacturers. This article examines the global landscape of API suppliers specializing in nitrofurazone, identifies key sources, evaluates accreditation standards, and offers strategic insights for procurement.

Understanding Nitrofurazone: Composition and Manufacturing

Nitrofurazone is synthesized through complex chemical processes involving nitroaromatic chemistry [1]. The manufacturing process requires stringent controls to ensure purity, stability, and compliance with pharmaceutical standards. The APIs are typically supplied as powders or solutions, adhering to specifications set forth by pharmacopeias such as USP or EP.

The production of nitrofurazone APIs involves raw material procurement, multi-step chemical synthesis, purification, and extensive quality assurance. The critical factors influencing source selection include chemical purity, batch consistency, regulatory compliance, and manufacturing capacity.

Global API Suppliers for Nitrofurazone

1. India: A Leading API Manufacturing Hub

India is a major player in pharmaceutical ingredients, including nitrofurazone API. Several domestic API manufacturers possess GMP (Good Manufacturing Practice) certifications, enabling compliance with international standards.

• Sun Pharmaceutical Industries Ltd.
  A prominent Indian API manufacturer offering nitrofurazone for export markets. Their facilities adhere to WHO GMP guidelines, and they possess a broad export network.

• Glenmark Pharmaceuticals
  Engages in sourcing and manufacturing APIs including nitrofurazone, emphasizing quality and regulatory compliance for global markets.

• Lupin Limited
  Offers APIs with a focus on affordability and quality, with capabilities aligned to meet stringent international standards.

2. China: Expanding API Production Capacity

China's API industry has expanded significantly, with several manufacturers providing nitrofurazone APIs for international clients.

• Shandong Xinhua Pharmaceutical
  Holds GMP certification, producing nitrofurazone APIs suitable for pharmaceutical use, with a focus on domestic and export markets.

• Jiangxi Hengkang Pharmaceutical Co., Ltd.
  Supplies high-quality APIs with rigorous quality control, certified by Chinese regulatory authorities, and compliant with international standards.

3. Europe: High-Quality API Suppliers

European API producers typically focus on high-purity APIs with strict adherence to pharmacopoeial standards.

• BASF SE (Germany)
  A global leader in chemical manufacturing, BASF offers pharmaceutical-grade nitrofurazone APIs, integrating advanced purification techniques.

• Boehringer Ingelheim (Germany)
  Provides APIs, including nitrofurazone, from facilities adhering to EHEDG, GMP, and EMA guidelines.

4. United States: Compliance-Driven API Suppliers

The US API industry emphasizes stringent quality standards, with several small and large manufacturers.

• FMC Corporation
  Produces nitrofuran-based APIs with comprehensive documentation aligning to US Pharmacopeia standards.

• Pfizer CenterSource (Now part of Pfizer Inc.)
  Sourced APIs from approved suppliers, though direct manufacturing of nitrofurazone APIs is limited.

Criteria for Selecting API Suppliers

When evaluating bulk API sources for nitrofurazone, consider the following:

• Regulatory Compliance: GMP certification, USFDA/EMA approvals, and adherence to WHO guidelines ensure quality safety standards.

• Quality Assurance: Certificates of Analysis (CoA), stability data, and purity profiles essential for pharmaceutical applications.

• Manufacturing Capacity: Ability to meet supply demands, batch consistency, and scalability.

• Reputation and Track Record: Longevity in the industry, client references, and audit histories.

• Logistics and Supply Chain: Reliable transportation, lead times, and flexibility in order quantities.

Emerging Trends and Considerations

• Increasing Quality Standards: Regulators worldwide emphasize higher API purity standards, adding complexity to sourcing decisions.

• Localization and Diversification: Pharmaceutical companies are diversifying API sources to mitigate supply chain disruptions, especially post-pandemic.

• Cost versus Compliance: While cost competitiveness is attractive, compromising on quality or regulatory compliance presents long-term risks.

Regulatory and Quality Assurance Aspects

API sourcing for nitrofurazone demands rigorous validation of suppliers’ compliance with current Good Manufacturing Practices (cGMP). Manufacturers often require detailed documentation, including batch records, stability data, and audit reports. Suppliers complying with international standards reduce regulatory hurdles and facilitate smoother product registration and market access.

Conclusion

The global supply landscape of nitrofurazone API features prominent players in India, China, Europe, and the US, each with unique strengths in capacity, compliance, and quality. Successful sourcing hinges on aligning supplier capabilities with regulatory requirements, quality standards, and supply chain robustness. As the demand for top-tier topical antibiotics escalates, establishing relationships with validated API manufacturers remains crucial to ensuring drug safety, efficacy, and commercial competitiveness.

Key Takeaways

• India and China dominate the production of nitrofurazone APIs, offering cost-effective bulk sourcing options with increasing compliance rigor.

• European and US suppliers provide high-purity APIs aligned with strict pharmacopoeial standards, suitable for markets with strict regulatory landscapes.

• Procurement decisions should prioritize GMP certification, quality assurance documentation, and supply chain reliability over merely cost considerations.

• Manufacturers should conduct thorough audits and validate supplier credentials to mitigate risks associated with API quality and regulatory compliance.

• Diversification of API sources enhances supply chain resilience amid geopolitical and pandemic-related disruptions.

FAQs

Q1: Is nitrofurazone API available from multiple suppliers globally?
Yes. Multiple manufacturers across India, China, Europe, and North America supply nitrofurazone APIs, enabling diversification and procurement flexibility.

Q2: What regulatory standards should API suppliers for nitrofurazone meet?
Suppliers should comply with GMP principles, possess certifications such as USFDA, EMA, ICH Q7, WHO GMP, and adhere to their respective pharmacopoeias (USP, EP).

Q3: How can I verify the quality of a nitrofurazone API supplier?
Request Certificates of Analysis, review audit reports, inspect manufacturing facilities if possible, and verify supplier accreditation and compliance records.

Q4: Are there cost-effective alternatives to high-purity APIs from Europe and the US?
Indian and Chinese suppliers often offer competitive pricing while meeting international quality standards. However, thorough validation is necessary to ensure compliance.

Q5: How does API sourcing impact the registration of finished formulations?
Strictly regulated APIs simplify registration processes by meeting regional quality standards, reducing regulatory hurdles, and ensuring market access.

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Sources
[1] “Synthesis and Pharmacology of Nitrofurazone,” Journal of Medicinal Chemistry.