Suppliers and packagers for NIZATIDINE

NIZATIDINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Ltd	NIZATIDINE	nizatidine	CAPSULE;ORAL	077314	ANDA	Dr Reddy's Laboratories Limited	55111-310-01	100 CAPSULE in 1 BOTTLE (55111-310-01)	2005-09-15
Dr Reddys Labs Ltd	NIZATIDINE	nizatidine	CAPSULE;ORAL	077314	ANDA	Dr Reddy's Laboratories Limited	55111-310-05	500 CAPSULE in 1 BOTTLE (55111-310-05)	2005-09-15
Dr Reddys Labs Ltd	NIZATIDINE	nizatidine	CAPSULE;ORAL	077314	ANDA	Dr Reddy's Laboratories Limited	55111-310-30	30 CAPSULE in 1 BOTTLE (55111-310-30)	2005-09-15

Suppliers for the Pharmaceutical Drug: Nizatidine

Last updated: July 29, 2025

Introduction

Nizatidine is a histamine-2 (H2) receptor antagonist primarily used to treat gastrointestinal conditions such as duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Marketed under various brand names like Axid, it belongs to a class of drugs that suppress gastric acid secretion. While its patent expired in many regions, prompting increased generic production, supply chain integrity remains critical for healthcare providers, pharmacies, and patients.

This report analyzes the current landscape of Nizatidine suppliers, covering original manufacturers, generic producers, regional variations, and supply chain considerations, offering insights crucial for stakeholders in the pharmaceutical sector.

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Original Manufacturers

Historically, Nizatidine was developed and marketed by Takeda Pharmaceuticals, with Axid being its primary brand. Takeda initially held the patent rights and controlled the drug’s distribution during the patent period. However, patent expirations in key markets like the United States and Europe led to the entry of generic competitors.

Takeda's role has since shifted toward licensing, regulatory approvals, and oversight of manufacturing processes rather than direct mass production of Nizatidine. Consequently, the original patent-holder's influence on current supply chains has diminished, emphasizing the transition toward generic suppliers.

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Generic Manufacturers and Suppliers

Post-patent expiration, several generic pharmaceutical companies now manufacture Nizatidine, significantly expanding the global supply base. Key players include:

1. Indian Pharmaceutical Companies

India’s generic sector dominates Nizatidine production, leveraging cost-effective manufacturing and robust export markets. Prominent manufacturers include:

• Sun Pharmaceutical Industries Ltd.
  Known for high-volume production and compliance with international quality standards, Sun Pharma supplies Nizatidine to various markets worldwide.

• Dr. Reddy’s Laboratories
  With ISO-certified facilities, Dr. Reddy’s produces Nizatidine as part of its gastrointestinal portfolio, supporting both domestic and export demands.

• Gland Pharma
  Recognized for injectables but also engaged in oral formulations like Nizatidine, Gland Pharma ensures consistent supply, particularly to emerging markets.

• Aurobindo Pharma
  Offers Nizatidine tablets internationally, adhering to stringent regulatory standards, including USFDA approvals.

2. Chinese Pharmaceutical Companies

China’s rapidly growing pharmaceutical manufacturing sector supplies Nizatidine primarily to Asian markets and increasingly to global distributors. Notable Chinese producers include:

• Shanghai Jingqi Pharmaceutical
  A key supplier with domestic distribution and export capabilities.

• Zhejiang Huahai Pharmaceuticals
  Known for producing a wide range of gastrointestinal drugs, including Nizatidine.

3. European and US-Based Generic Manufacturers

While the global manufacturing landscape is dominated by India and China, some European and US firms produce Nizatidine under strict regulatory oversight, often for niche markets or as part of broader formulations.

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Regional Supply Dynamics

United States

In the US, generic Nizatidine has been approved by the Food and Drug Administration (FDA), with multiple manufacturers holding Abbreviated New Drug Applications (ANDAs). The supply is generally stable, but market dynamics fluctuate with pricing and regulatory compliance.

Europe

European supply is predominantly from Indian and European generic companies, dependent on European Medicines Agency (EMA) approvals. Market sustainability hinges on patent statuses and regional demand.

Asia-Pacific

This region relies heavily on Chinese and Indian manufacturers for cost-effective Nizatidine supplies, serving both local and export markets, including emerging economies.

Emerging Markets

Countries such as Brazil, South Africa, and Southeast Asian nations source Nizatidine mainly from Indian suppliers, often favoring local distributors or importers.

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Supply Chain Considerations

• Regulatory Approvals: Manufacturers complying with approvals from FDA, EMA, and other agencies ensure quality, influencing supplier legitimacy.

• Manufacturing Capacity: The ability of suppliers to meet global demand varies, with Indian companies leading in scalability.

• Quality Assurance: Good Manufacturing Practices (GMP) certifications are essential criteria for supplier qualification.

• Supply Chain Risks: Political, logistical, and regulatory disruptions—exemplified during the COVID-19 pandemic—highlight the importance of diversifying suppliers.

• Pricing Dynamics: Competition among generic suppliers has driven down prices, but supply stability remains critical.

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Emerging Trends & Future Outlook

• Regulatory Re-Evaluation: As patents expired, regulatory agencies have prioritized quality standards, affecting supplier eligibility.

• Innovation in Formulation: Some manufacturers are exploring new formulations—delayed-release, combination therapies—that may influence supply chain configurations.

• Global Supply Chain Diversification: Stakeholders increasingly seek diversified supplier bases to mitigate risks associated with geopolitical tensions and trade barriers.

• Potential Shortages: Disruptions in key manufacturing hubs pose risks of shortages, underscoring the need for proactive capacity planning.

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Key Takeaways

• The shift from original patent-holders (e.g., Takeda) to a broad base of generic producers, primarily Indian and Chinese companies, now dominates Nizatidine supply.

• Indian pharmaceutical companies such as Sun Pharma, Dr. Reddy’s, and Gland Pharma are leading suppliers, supported by Chinese manufacturers like Shanghai Jingqi.

• Quality assurance via GMP certifications and regulatory compliance remain critical for supplier credibility.

• Regional demand influences supplier choices, with stable supply chains prevalent in mature markets like the US; emerging markets rely heavily on Indian and Chinese manufacturers.

• Diversification and robust regulatory oversight are vital for securing consistent supply amid global disruptions.

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FAQs

1. Are there any current supply shortages of Nizatidine?
While historically stable, recent supply disruptions—due to manufacturing issues or regulatory delays—have occasionally led to shortages in specific markets. Stakeholders should monitor regulatory updates and supplier capacities regularly.

2. What are the main regions sourcing Nizatidine from Indian manufacturers?
India remains the primary source for Nizatidine globally, especially for emerging economies and export markets, owing to its cost-effective manufacturing and regulatory compliance.

3. How does regulatory approval impact Nizatidine suppliers?
Regulatory approval from authorities like the FDA and EMA ensures quality and safety standards, making approved suppliers more reliable. Non-compliant manufacturing facilities face restrictions, affecting supply continuity.

4. Can I identify specific brands or suppliers of Nizatidine?
Many generic Nizatidine products are manufactured discreetly under various brand names, usually by large pharmaceutical companies. Buyers typically verify suppliers through regulatory databases or pharmacovigilance reports.

5. What is the outlook for Nizatidine supplier growth?
With patent expirations, the market for Nizatidine is expected to expand, driven by increasing gastrointestinal conditions and generic drug adoption, maintaining growth among existing suppliers and attracting new entrants.

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Sources

1. U.S. Food and Drug Administration. Approved Drug Products: Nizatidine.
2. Indian Pharmaceutical Industry Reports. Pharma Business News.
3. European Medicines Agency (EMA). Nizatidine approvals.
4. Market analysis reports from IQVIA and GlobalData on gastrointestinal drugs.
5. Company filings and official websites of Sun Pharma, Dr. Reddy's, and Gland Pharma.