Bulk Pharmaceutical API Sources for NITAZOXANIDE

Bulk Pharmaceutical API Sources for NITAZOXANIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Vitas-M Laboratory		STK395664
Molport		MolPort-002-042-244
Hangzhou APIChem Technology		AC-1302
Amadis Chemical		A830877

Bulk Active Pharmaceutical Ingredient (API) Sources for Nitazoxanide

Last updated: July 29, 2025

Introduction

Nitazoxanide is an antiprotozoal and antiviral medication primarily used to treat parasitic infections, including Cryptosporidium parvum and Giardia lamblia, and has garnered interest for its potential antiviral properties. As a globally approved drug, the procurement of high-quality bulk active pharmaceutical ingredients (APIs) is crucial for pharmaceutical manufacturers, research institutions, and public health agencies. This report explores current API sources for nitazoxanide, evaluating manufacturing capacity, compliance, and market dynamics.

Understanding Nitazoxanide as an API

Nitazoxanide’s chemical complexity stems from its benzamidazole core, which requires precise synthetic pathways. It is synthesized through multi-step chemical processes involving chlorination, amidation, and other transformations. As such, reputable API sources must demonstrate robust manufacturing processes, rigorous quality control, and compliance with international standards such as Good Manufacturing Practices (GMP).

Global API Manufacturing Landscape for Nitazoxanide

Leading API Producers

The API market for nitazoxanide is characterized by a limited yet specialized set of manufacturers, predominantly based in India, China, and other emerging markets. These sources generally supply both generic versions and stringent regulatory compliant APIs.

India

India remains the dominant supplier of nitazoxanide APIs, owing to its well-established pharmaceutical infrastructure. Major manufacturers include:

• Zydus Cadila: A vertically integrated pharmaceutical company with GMP-compliant API production, Zydus provides APIs for both domestic and international markets. Their facilities are inspected regularly by the US FDA and EMA, ensuring compliance with global quality standards.
• Aurbindo Pharma: Known for manufacturing a broad spectrum of APIs, including nitazoxanide, Aurbindo emphasizes high purity grades suitable for pharmaceutical use.
• Cipla: A significant player with proven API manufacturing capacity, Cipla maintains strict quality assurance protocols, with APIs approved in multiple regulatory jurisdictions.

China

Chinese API manufacturers supply a significant volume of nitazoxanide APIs, often at competitive prices. Reputable Chinese companies include:

• North China Pharmaceutical Group Corporation (NCPC): Produces APIs adhering to GMP standards, targeting global markets.
• Hubei Hongxin Pharmaceutical Co., Ltd.: Offers APIs with detailed quality documentation, focusing on continuous GMP compliance.

Other Countries

Emerging markets like Bangladesh and Vietnam have smaller-scale API manufacturers, though quality assurance might vary. Such sources are generally suitable for research purposes or as secondary suppliers.

Key Factors in API Sourcing

• Quality Standards: GMP compliance, ISO certifications, and third-party audits.
• Regulatory Approval: Suppliers must provide Certificates of Analysis (CoA), stability data, and validation documentation.
• Supply Capacity: Consistent, reliable supply chains are essential.
• Pricing: Competitive pricing must be balanced against quality and regulatory compliance.
• Longevity & Reputation: Establishing long-term relationships with reliable suppliers minimizes supply disruptions.

Market Dynamics and Regulatory Considerations

The demand for nitazoxanide API is influenced by its approved indications and ongoing research into broader antiviral applications. Manufacturers vying for market share must navigate complex regulatory pathways in different jurisdictions, with recognized API sources facilitating smoother registration and quality assurance processes.

Regulatory agencies such as the US FDA, EMA, and WHO conduct routine inspections, influencing the acceptance level of API sources. Suppliers with certified GMP facilities and proven compliance gain a significant advantage in international markets.

Emerging Trends and Future Outlook

• Quality Enhancement and Certification: Increasing demand for high-quality APIs encourages suppliers to upgrade facilities and obtain certifications like ISO 9001, WHO-GMP.
• Development of Synthetic Pathways: Advances in synthetic chemistry may enhance yield and reduce costs, expanding API production capabilities.
• Partnerships and Licensing: Major manufacturers are exploring licensing agreements to expand supply through technology transfer, particularly in regions with high disease prevalence.

Challenges in API Supply Chain

• Regulatory Hurdles: Differing standards and inspection requirements can delay approvals.
• Price Fluctuations: Variability in raw material costs and geopolitical factors impact pricing.
• Quality Variability: Ensuring consistent quality across batches remains a key concern, especially from emerging market producers.

Key Suppliers Summary

Company	Country	GMP Certification	Notable Features
Zydus Cadila	India	Yes	Fully integrated, global supply
Aurbindo Pharma	India	Yes	Focus on high-purity APIs
Cipla	India	Yes	Long-standing reputation
NCPC	China	Yes	Competitive pricing
Hubei Hongxin	China	Yes	Growing international presence

Conclusion

The procurement of nitazoxanide API relies on a strategic selection of suppliers emphasizing quality, regulatory compliance, and supply reliability. India’s API manufacturing sector dominates, supported by China’s competitive offerings, while emerging markets play a supplementary role. Ensuring GMP compliance and thorough verification remains critical for clinical, commercial, or research use. As demand grows, particularly amid antiviral research, the API supply landscape is poised for expansion, emphasizing quality enhancement and integrated supply chains.

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Key Takeaways

• India and China are primary sources, with Indian manufacturers leading in regulatory compliance and quality assurance.
• Manufacturers must demonstrate GMP certification and provide comprehensive documentation for regulatory approvals.
• Long-term partnerships with established suppliers mitigate supply risks.
• Continued advancements in synthetic processes could improve yield, reduce costs, and expand supply capacity.
• Rigorous supplier validation and quality audits are crucial for compliance and patient safety.

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FAQs

1. Are APIs from China as reliable as those from India?
Yes, many Chinese API manufacturers now hold GMP certifications and international accreditations, making them as reliable as Indian counterparts. However, due diligence, including auditing and certification verification, remains essential.

2. What quality standards should suppliers of nitazoxanide API meet?
Suppliers should adhere to GMP standards, possess necessary certifications (e.g., ISO, WHO-GMP), and provide comprehensive quality documentation, including Certificates of Analysis and stability data.

3. Can APIs from emerging markets be used for regulatory submissions?
While possible, regulatory agencies may require thorough audits and validation to accept APIs from emerging markets. Engaging suppliers with established international compliance enhances approval prospects.

4. How does the price of nitazoxanide API vary globally?
Prices are influenced by manufacturing costs, quality standards, and supplier reputation. Indian and Chinese sources typically offer competitive pricing, with slight variations based on order volume and certification status.

5. What trends are shaping the future of nitazoxanide API supply?
Trends include increased GMP compliance, synthetic process innovation, and strategic licensing agreements. Additionally, a focus on supply chain resilience will drive supplier evaluations and partnerships.

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References

[1] Global Pharmaceutical API Market Overview. (2022). Pharmaceutical Technology.
[2] WHO Guidelines on GMP for Pharmaceutical Products. (2021). World Health Organization.
[3] Indian Pharmaceuticals Sector – Market Outlook. (2022). Indian Brand Equity Foundation (IBEF).
[4] Chinese API Industry Standards and Certifications. (2021). China Pharmaceutical Industry Association.
[5] Regulatory Considerations in API Sourcing. (2023). U.S. FDA.