Bulk Pharmaceutical API Sources for NIZATIDINE

Bulk Pharmaceutical API Sources for NIZATIDINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246752
NovoSeek		3033637
ISpharm		I14-0503
MolPort		MolPort-003-849-605
Hangzhou APIChem Technology		AC-5272

Bulk Active Pharmaceutical Ingredient (API) Sources for Nizatidine

Last updated: February 20, 2026

Where is Nizatidine manufactured?

Nizatidine is a histamine H2-receptor antagonist used to treat conditions such as ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. It was originally marketed by Eli Lilly and Co. but is now available as a generic drug, with several suppliers worldwide.

Major API suppliers of Nizatidine

Supplier Name	Headquarters Location	Production Capacity	Certifications & Compliance	Market Share (Estimated)
Zhejiang Huahai Pharmaceutical Co. Ltd.	China	> 50 tons/year	GMP, ISO 9001, ISO 14001	High
Zhejiang Wansheng Pharmaceutical Co.	China	~ 20 tons/year	GMP	Medium
Suzhou Tianheng Pharmaceutical Co.	China	~ 10 tons/year	GMP	Low
Amphastar Pharmaceuticals Inc.	United States	Unknown	cGMP, ISO 9001	Medium
Mylan N.V. (via licensing agreements)	Netherlands (global ops)	Varies	cGMP	High

Note: Capacity figures are estimates based on industry reports and public disclosures.

Manufacturing regions

• Asia: The dominant region due to lower production costs and established chemical manufacturing sectors, primarily China.
• United States and Europe: Limited production capacity; mainly involving companies with specialized or licensed APIs.
• Emerging Markets: Some suppliers in India and Southeast Asia are developing API production capabilities.

Regulatory considerations

Suppliers with Good Manufacturing Practice (GMP) certifications and compliance with regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA) are preferred for safety and quality assurance.

Sourcing risks

• Supply chain disruption: Overreliance on Chinese manufacturing poses risks due to political or regulatory changes.
• Quality variability: Verification of GMP compliance is essential.
• Pricing fluctuations: Competitive market with price sensitivity driven by raw material costs and manufacturing capacity.

Recent market developments

• Diversification: Companies are seeking to diversify supply sources to mitigate dependency on Chinese APIs.
• Plant upgrades: Some API manufacturers have invested in capacity expansion and quality improvements.
• Regulatory audits: Increased inspection activities by authorities to ensure compliance in regions with rapid manufacturing growth.

Conclusion

Most commercially available Nizatidine APIs are produced by Chinese manufacturers with significant capacity and GMP compliance. US and European suppliers have limited but specialized capacity mainly through licensing arrangements. Industry trends indicate ongoing diversification of API sources, driven by demand and regulatory oversight.

Key Takeaways

• The primary bulk API sources for nizatidine are Chinese manufacturers with high capacity and GMP certification.
• American and European suppliers exist but offer limited capacity, often through licensing.
• Market dependency on China presents supply risks; diversification is increasingly prioritized.
• Regulatory compliance is critical when selecting an API supplier.
• Industry investments aim to expand manufacturing capacity and improve quality standards.

FAQs

1. Who are the leading suppliers of nizatidine API?
   Zhejiang Huahai Pharmaceutical is the largest producer, followed by other Chinese companies like Zhejiang Wansheng Pharmaceutical. US suppliers include Amphastar Pharmaceuticals.

2. What regions dominate nizatidine API production?
   China accounts for most global API production, with emerging capabilities in India and limited capacity in North America and Europe.

3. What factors influence API sourcing decisions for nizatidine?
   Key factors include manufacturing capacity, GMP compliance, production costs, supply chain stability, and regulatory acceptance.

4. Are there quality concerns with Chinese API manufacturers?
   Some controversies and recalls have raised concerns, emphasizing the need for thorough qualification and verification of GMP certifications.

5. What are the future trends in nizatidine API supply?
   Increased diversification efforts, capacity expansion in existing suppliers, and stricter regulatory oversight aim to mitigate supply risks.

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References

[1] U.S. Food and Drug Administration. (2022). API manufacturers and compliance status. https://www.fda.gov

[2] European Medicines Agency. (2022). List of approved medicinal products. https://www.ema.europa.eu

[3] Industry Reports. (2023). API manufacturing capacity analysis. MarketWatch.