Suppliers and packagers for FAMOTIDINE

FAMOTIDINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	217529	ANDA	Ajanta Pharma USA Inc.	27241-249-49	50 mL in 1 BOTTLE (27241-249-49)	2022-04-25
Alkem Labs Ltd	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	216400	ANDA	Ascend Laboratories, LLC	67877-775-89	50 mL in 1 BOTTLE (67877-775-89)	2023-08-24
Amneal	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	216427	ANDA	Amneal Pharmaceuticals NY LLC	60219-2090-4	50 mL in 1 BOTTLE (60219-2090-4)	2024-05-13
Amneal	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	216427	ANDA	Amneal Pharmaceuticals NY LLC	69238-2090-4	50 mL in 1 BOTTLE (69238-2090-4)	2022-08-05
Annora Pharma	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	217330	ANDA	Camber Pharmaceuticals, Inc.	31722-063-31	50 mL in 1 BOTTLE (31722-063-31)	2023-08-17
Appco	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	217655	ANDA	Upsher-Smith Laboratories, LLC	0832-6045-10	100 mL in 1 BOTTLE (0832-6045-10)	2023-06-16

Suppliers for the Pharmaceutical Drug: FAMOTIDINE

Last updated: July 29, 2025

Introduction

Famotidine, a histamine H2 receptor antagonist, is widely used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome. Since its initial approval in the late 1980s, famotidine has become a staple in gastrointestinal therapy, with a broad manufacturing and supply network. This article examines the key suppliers of famotidine, highlighting global manufacturing trends, regulatory considerations, and the implications for supply chain stability in the pharmaceutical industry.

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Global Manufacturing Landscape of Famotidine

Famotidine's production ecosystem spans multiple continents, predominantly driven by generic pharmaceutical companies. Major suppliers are situated in North America, Asia, and Europe, reflecting the drug’s widespread demand and patent expiry.

North American Suppliers

In North America, leading pharmaceutical companies such as Mylan (now part of Viatris), Teva Pharmaceuticals, and Novartis have historically been significant producers. These companies manufacture famotidine under strict regulatory standards, including approval by the U.S. Food and Drug Administration (FDA). Mylan's historical prominence in the famotidine market has been underscored by its ability to supply both branded and generic formulations.

Asian Manufacturers

Asia, notably China and India, houses the majority of famotidine manufacturing facilities. Companies like Julphar (UAE-based with manufacturing in India), Cadila Healthcare, Sun Pharmaceutical Industries, and Dr. Reddy's Laboratories have emerged as major suppliers. Indian generic manufacturers benefit from cost advantages and large-scale production capabilities, enabling them to supply both domestic and international markets.

European Suppliers

While Europe has fewer dedicated famotidine producers, firms such as Sandoz (a Novartis division) and Hikma Pharmaceuticals have contributed through manufacturing and distribution partnerships, especially within the European Union and Middle Eastern markets.

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Key Suppliers and Their Market Strategies

1. Mylan/Viatris

Mylan, historically a dominant famotidine supplier, leveraged extensive manufacturing facilities in India and the United States. Following its merger with Pfizer’s off-patent drugs unit, Viatris continues to supply famotidine globally, emphasizing affordable generic options.

2. Teva Pharmaceuticals

Teva maintains a robust portfolio of gastrointestinal drugs including famotidine. Its manufacturing plants in Israel, India, and the United States align with its strategy of broadening access and maintaining supply chain resilience.

3. Indian Generics Manufacturers

• Cadila Healthcare: Operates multiple facilities producing famotidine, primarily targeting domestic and emerging markets.
• Sun Pharmaceutical Industries: One of the world's largest generics manufacturers, Sun Pharma produces famotidine with a focus on cost-effective formulations.
• Dr. Reddy’s Laboratories: Offers famotidine tablets internationally, leveraging its extensive API (Active Pharmaceutical Ingredient) manufacturing capabilities.

4. Chinese Manufacturers

Chinese firms such as Shanghai Pharmaceuticals and Hengkang Medical benefit from lower manufacturing costs and are increasingly supplying to international markets through exports and partnerships. However, their regulatory compliance standards can vary, impacting global supply chain reliability.

5. Contract Manufacturing Organizations (CMOs)

Major pharmaceutical companies often engage CMOs to produce famotidine, ensuring scalability and compliance with Good Manufacturing Practices (GMP). These include firms like Zhejiang Hua pharmaceutical in China and Ranbaxy (now part of Sun Pharma) in India.

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Regulatory and Quality Considerations

Global supply continuity relies heavily on compliance with regulatory standards, notably those established by the FDA, EMA, and other national agencies. As regulators tighten quality controls, particularly for Chinese and Indian manufacturers, supply chain risks may increase. Manufacturers investing in quality assurance, transparency, and robust supply chain management modes are better positioned to sustain market demands.

The World Health Organization (WHO) prequalification program also influences manufacturer compliance, especially for suppliers targeting low- and middle-income countries (LMICs). Manufacturers that meet WHO standards gain easier access to global procurement channels, enhancing supply stability.

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Supply Chain Disruptions and Market Dynamics

The COVID-19 pandemic starkly exposed vulnerabilities in the global pharmaceutical supply chain, affecting the availability of APIs and finished formulations. Famotidine supply was notably impacted due to disruptions in API production and freight logistics. Additionally, increased demand during the pandemic for various gastrointestinal medications, including off-label use of famotidine, intensified supply pressures.

Governments and pharmaceutical firms are now exploring strategic stockpiles, diversified sourcing, and regional manufacturing hubs to mitigate supply risks.

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Emerging Trends and Future Outlook

1. API Consolidation and Vertical Integration

In response to supply chain fragility, some manufacturers are integrating API production within their manufacturing ecosystems, reducing dependency on third-party suppliers.

2. Regulatory Harmonization

Enhanced regulatory enforcement, especially concerning quality standards, may influence supplier viability. Manufacturers investing in compliance may command greater trust in global markets.

3. Biosimilar and Alternative Therapies

While famotidine remains prevalent, the development of alternative GI therapies, including proton pump inhibitors (PPIs), could influence demand and, consequently, supplier traction.

4. Geographic Diversification

Manufacturers are increasingly seeking to diversify manufacturing bases beyond traditional hubs, such as India and China, to ensure resilience against region-specific disruptions.

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Implications for Industry Stakeholders

• Pharmaceutical Buyers: Need to prioritize suppliers with strong regulatory compliance, quality assurance, and diversified manufacturing footprints.
• Investors: Should monitor manufacturer capacity expansion, regulatory clearance, and geopolitical factors impacting supply reliability.
• Regulators: Must enforce stringent quality standards to prevent supply shortages stemming from subpar manufacturing practices.
• Manufacturers: Should invest in robust supply chain management, API sourcing strategies, and regulatory compliance to ensure continued market access.

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Key Takeaways

• The global famotidine supply chain heavily relies on Indian and Chinese generic manufacturers, complemented by established players in North America and Europe.
• Quality compliance and regulatory adherence are critical for supplier reliability and market access.
• Supply disruptions during the COVID-19 pandemic have underscored the necessity for diversification and strategic inventory management.
• Emerging trends favor regional manufacturing, API integration, and regulatory harmonization to bolster supply resilience.
• Stakeholders must continuously evaluate supplier capabilities against evolving regulatory and geopolitical landscapes to secure a stable famotidine supply.

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FAQs

1. Who are the top suppliers of famotidine globally?
   Major suppliers include Mylan/Viatris, Teva Pharmaceuticals, Indian generics firms such as Sun Pharma, Cadila Healthcare, and Dr. Reddy’s Laboratories, alongside Chinese manufacturers like Shanghai Pharmaceuticals.

2. What regulatory considerations affect famotidine supply?
   Compliance with GMP standards, FDA/EMA approval, and WHO prequalification are essential criteria that influence manufacturer eligibility and supply stability.

3. How has the COVID-19 pandemic affected famotidine supply?
   The pandemic caused disruptions in API manufacturing and logistics, leading to shortages and increased demand for stockpiling, revealing vulnerabilities in supply chains.

4. Are there regional differences in famotidine manufacturing?
   Yes. North American and European markets have higher regulatory standards, with India and China dominating API and formulation manufacturing due to cost advantages and capacity.

5. What trends are shaping the future of famotidine supply?
   Trends include API vertical integration, diversification of manufacturing bases, stronger regulatory enforcement, and adapting to shifting therapeutic markets.

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References

1. U.S. Food and Drug Administration (FDA). Famotidine Data.
2. GlobalData. Pharmaceutical Market Reports, 2022.
3. IQVIA Institute. The Changing Landscape of Gastrointestinal Therapeutics, 2021.
4. WHO Prequalification Program. List of accepted manufacturing sites, 2022.
5. Statista. Global API Manufacturing Capacity, 2020-2022.

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This comprehensive analysis offers vital insights into the current and future landscape of famotidine suppliers, enabling stakeholders to optimize sourcing strategies and mitigate supply chain risks.