Suppliers and packagers for generic pharmaceutical drug: NITAZOXANIDE

NITAZOXANIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	NITAZOXANIDE	nitazoxanide	TABLET;ORAL	214844	ANDA	ANI Pharmaceuticals, Inc.	70954-934-10	6 TABLET in 1 BOTTLE (70954-934-10)	2025-03-05
Rising	NITAZOXANIDE	nitazoxanide	TABLET;ORAL	213820	ANDA	Rising Pharma Holdings, Inc.	64980-526-03	30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)	2020-11-27
Rising	NITAZOXANIDE	nitazoxanide	TABLET;ORAL	213820	ANDA	Rising Pharma Holdings, Inc.	64980-526-21	12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21)	2020-11-27
Rising	NITAZOXANIDE	nitazoxanide	TABLET;ORAL	213820	ANDA	Rising Pharma Holdings, Inc.	64980-526-60	6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60)	2020-11-27

Suppliers for the Pharmaceutical Drug: Nitazoxanide

Last updated: August 1, 2025

Introduction

Nitazoxanide is a broad-spectrum antiparasitic and antiviral medication initially approved for the treatment of diarrhea caused by Giardia lamblia and Cryptosporidium parvum. In recent years, its potential for other therapeutic areas, including viral infections like hepatitis C, influenza, and COVID-19, has garnered attention. The global supply chain for nitazoxanide involves a combination of brand-name manufacturers, generic producers, active pharmaceutical ingredient (API) suppliers, and contract manufacturing organizations (CMOs). This analysis explores the landscape of suppliers involved in the production and distribution of nitazoxanide, emphasizing key players, market dynamics, geographic distribution, and regulatory considerations.

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Global Market Landscape

The supply chain for nitazoxanide is characterized by a mix of multinational pharmaceutical firms, generic drug manufacturers, and specialty chemical suppliers. As of 2023, the drug's manufacturing ecosystem comprises:

• API Producers primarily in India, China, and Europe.
• Formulation Manufacturers spread across emerging markets.
• Distribution Networks covering North America, Europe, Africa, and Asia.

The current surge in interest in nitazoxanide due to its investigational use against COVID-19 has intensified demand, prompting additional manufacturing commitments and strategic sourcing.

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Key Active Pharmaceutical Ingredient (API) Suppliers

India: The Epicenter of API Manufacturing

India dominates global API production for nitazoxanide, with several prominent companies supplying high-quality, cost-effective APIs. Their capabilities include synthesis, purification, and quality assurance aligned with international standards.

• Natco Pharma Ltd.
  Natco has been a significant supplier of APIs for antiparasitic drugs, including nitazoxanide. They possess advanced synthesis techniques and comply with WHO-GMP standards, enabling exports to North America, Europe, and Africa.

• Aurobindo Pharma Ltd.
  Aurobindo's extensive API portfolio covers antiparasitic compounds. Their nodal facilities are certified by US FDA and EMA, ensuring compliance for global distribution.

• Micro Labs Ltd.
  Known for diversified pharmaceutical R&D, Micro Labs produces nitazoxanide API for domestic and export markets, adhering to cGMP guidelines.

China: Growing Presence and Construction of API Capacity

Chinese API manufacturers have expanded capacity to meet rising global demand, especially in the wake of the COVID-19 pandemic.

• Shanghai Desano Pharmaceutical Co.
  Specializes in generic APIs, including nitazoxanide, with certifications for export to regulated markets.

• Sino Biopharmaceutical Limited
  Invests heavily in API production infrastructure, targeting antiviral and antiparasitic compounds.

European API Producers

While smaller in scale, European manufacturers focus on high-purity policies and often supply to branded formulations.

• BioComponents, S.A. (Spain)
  Provides custom synthesis services for APIs with high purity requirements.

Quality and Regulatory Considerations

API suppliers must conform to Good Manufacturing Practices (GMP) as mandated by regulators like the US FDA, EMA, and WHO prequalification programs, to ensure safety and efficacy.

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Formulation and Finished Dosage Product Suppliers

Once APIs are sourced, formulation manufacturing involves tablet, capsule, or suspension production. Several players are linked to this stage:

• Sun Pharmaceutical Industries Ltd. (India)
  Produces finished nitazoxanide formulations supplied to multiple countries.

• Hetero Labs Ltd. (India)
  Manufactures generic formulations at scale, with global distribution channels.

• Zhejiang Huadong Medicine Co., Ltd. (China)
  Focuses on Asian markets with local formulations.

Emerging Markets and Regional Distributors

In Africa and Southeast Asia, regional pharmaceutical firms often produce and distribute nitazoxanide, leveraging local manufacturing incentives and registration exemptions.

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Contract Manufacturing Organizations (CMOs)

The shift toward outsourcing manufacturing functions has led to increased reliance on CMOs specializing in API synthesis and formulation.

• Bachem AG (Switzerland)
  Provides custom synthesis services for APIs, including nitazoxanide.

• Samsung Biologics (South Korea)
  While primarily biopharmaceuticals-focused, they are expanding into small-molecule APIs.

• Dr. Reddy’s Laboratories (India)
  Offers contract manufacturing for APIs and finished formulations.

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Regulatory and Certification Landscape

Suppliers aiming for access to regulated markets must ensure compliance with certifications such as US FDA approvals, EMA manufacturing authorization, and WHO prequalification. Stringent quality controls, process validation, and documentation are prerequisites for inclusion in global procurement.

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Supply Chain Dynamics and Challenges

• Capacity Constraints: Increased demand from research on nitazoxanide for COVID-19 has strained supply chains, prompting capacity expansion at key API plants.

• Pricing Trends: Price fluctuations are linked to raw material costs, regulatory compliance, and geopolitical stability.

• Geopolitical Risks: Disruptions in India and China’s manufacturing sectors due to policy changes, export restrictions, or pandemics impact global supply.

• Quality Assurance: Ensuring consistent quality across suppliers remains critical, especially for APIs sourced from emerging markets.

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Conclusion

The supply ecosystem for nitazoxanide is geographically diverse, predominantly driven by Indian and Chinese API manufacturers, supplemented by European companies. The converge of high-quality API sourcing, regulatory compliance, and manufacturing capacity expansion is essential to meet global demand. Businesses seeking reliable suppliers must prioritize vendors with proven compliance histories, scalable capacity, and robust distribution channels, especially given the increasing therapeutic interest in nitazoxanide.

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Key Takeaways

• Indian API manufacturers like Natco and Aurobindo are central to the global supply of nitazoxanide, offering cost-effective, GMP-compliant products.
• Chinese manufacturers are rapidly expanding capacity, aiming to meet rising demand, especially for antiviral applications.
• European and regional manufacturers serve niche markets with high-quality standards.
• Contract manufacturing organizations facilitate flexible production, especially during demand surges.
• Ensuring supplier compliance with international quality standards is crucial for maintaining supply chain integrity amid fluctuating geopolitical and market conditions.

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FAQs

1. Who are the leading suppliers of nitazoxanide API globally?
Major suppliers include Indian companies like Natco Pharma and Aurobindo Pharma, Chinese manufacturers such as Shanghai Desano Pharmaceutical, and European firms like BioComponents. Their combined capacities support robust global distribution.

2. What quality standards must API suppliers for nitazoxanide meet?
Suppliers must adhere to GMP, US FDA, EMA, and WHO prequalification standards. Certification ensures product purity, stability, and regulatory acceptance for international markets.

3. Are there regional differences in nitazoxanide supply chain reliability?
Yes. Indian and Chinese suppliers dominate, with Indian API producers generally more established for export, while Chinese suppliers are expanding their capacity. European manufacturers focus on high-grade markets.

4. Has the COVID-19 pandemic affected nitazoxanide supply?
Yes. Increased interest for COVID-19 treatments has strain existing capacities, prompting capacity expansions and supply chain adjustments among API producers.

5. What should companies consider when sourcing nitazoxanide?
They should evaluate supplier compliance with regulatory standards, capacity scalability, quality assurance processes, delivery timelines, and geopolitical stability to mitigate risks.

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References

1. World Health Organization. Prequalification of Active Pharmaceutical Ingredients. WHO, 2022.
2. US Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. FDA, 2023.
3. Indian Pharmaceutical Association. API Manufacturing and Export Trends. IPA Report, 2023.
4. Chinese Pharmacopoeia. API Certification and Standards. Chinese Pharmacopoeia Commission, 2022.
5. MarketWatch. Global API Market Analysis. MarketWatch, 2023.