Suppliers and packagers for ACIPHEX

ACIPHEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973	NDA	Waylis Therapeutics LLC	80725-243-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)	2022-05-15

Suppliers for the Pharmaceutical Drug: Aciphex

Last updated: July 30, 2025

Introduction

Aciphex, the brand name for rabeprazole sodium, is a proton pump inhibitor (PPI) used primarily to treat gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and other acid-related disorders. The drug functions by inhibiting gastric acid secretion, providing symptomatic relief and promoting mucosal healing. Due to its widespread use, a robust supply chain comprising multiple suppliers ensures drug availability and market stability. This article explores the key suppliers involved in the manufacturing, formulation, and distribution of Aciphex, analyzing their roles and market significance.

Manufacturers of Active Pharmaceutical Ingredient (API): Rabeprazole Sodium

The core of Aciphex’s production hinges on the supply of high-quality rabeprazole sodium API. Several pharmaceutical manufacturers dominate this market:

1. Eisai Co., Ltd.

Eisai Co., Ltd., a Japanese pharmaceutical giant, originally developed rabeprazole. The company holds substantial patents and manufacturing rights for the API, making it a principal supplier for global markets. Eisai’s production facilities in Japan and China are integral to the supply of rabeprazole sodium, especially in Asia. Their rigorous quality controls and technological expertise ensure consistent API supply essential for the production of Aciphex.

2. Teva Pharmaceuticals

Teva, an Israeli multinational, is one of the world's largest generic pharmaceutical manufacturers. It produces rabeprazole sodium API, serving both generic and proprietary markets. Teva’s extensive manufacturing infrastructure in Europe and Asia enables scalable API supply, competitive pricing, and compliance with international Good Manufacturing Practices (GMP).

3. China-based API Manufacturers

China plays a pivotal role as a supplier of rabeprazole sodium API, with several firms involved:

• Zhejiang Huahai Pharmaceutical: A leading Chinese API producer, with multiple GMP certifications and a significant share in the PPI market supply chain.

• Shanghai Desano Pharmaceutical Co., Ltd.: Known for manufacturing reliable generic APIs, including rabeprazole sodium, catering predominantly to Asian and emerging markets.

These Chinese companies benefit from cost advantages and rapid scalability but face scrutiny over quality standards in some cases.

4. Other Regional Suppliers

Companies in India and South Korea have also entered the rabeprazole API market, bolstered by robust manufacturing capacities and adherence to international quality standards, expanding supply options.

Formulation and Final Product Manufacturing

Beyond API production, Aciphex’s final formulation involves several key pharmaceutical firms:

• Eisai Co., Ltd.: As the original developer, Eisai continues to manufacture the branded product in select markets, especially Japan and select regions under controlled distribution channels.

• Domestic Generics Manufacturers: Various companies worldwide produce generic versions of Aciphex, often utilizing licensed APIs from Teva, Zhejiang Huahai, or other suppliers. These include Indian firms such as Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries, which manufacture and distribute generic rabeprazole-based medications.

• Contract Manufacturing Organizations (CMOs): Many pharmaceutical companies outsource formulation, tablet compression, and packaging to CMOs, particularly in India and Europe, ensuring production scale and regulatory compliance.

Distribution and Supply Chain Networks

The distribution of Aciphex involves global logistics networks, with suppliers and manufacturers adhering to stringent regulatory standards such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key distribution channels include:

• Pharmaceutical Wholesale Distributors: Companies like Cardinal Health, McKesson, and Alliance Boots distribute Aciphex to hospitals, clinics, and retail pharmacies.

• Direct-to-Pharmacy & Hospital Supplies: Some manufacturers and generic firms utilize direct procurement channels, especially for institutional clients.

• Online and E-Pharmacy Networks: Increasingly, Aciphex is available through licensed online pharmacies, requiring secure and verified supply routes to meet regulatory standards.

Emerging Trends and Market Dynamics

• Patent Expiry and Generics: The expiration of patent protection for branded Aciphex has spurred increased production by generic manufacturers, diversifying supply sources.

• Global Supply Chain Resilience: Recent disruptions, such as those caused by the COVID-19 pandemic, have prompted manufacturers to diversify sourcing, increase buffer stocks, and optimize logistics networks to maintain consistent supply.

• Regulatory Scrutiny and Quality Assurance: Authorities maintain strict oversight over API and finished product quality, influencing supplier selection and ongoing compliance.

Regulatory and Quality Considerations

Suppliers of rabeprazole sodium API and Aciphex formulations must adhere to GMP standards mandated by regulatory agencies. Non-compliance risks product recalls, supply disruptions, and legal liabilities. Companies with proven regulatory track records tend to solidify their position as preferred suppliers.

Conclusion

The supply ecosystem for Aciphex is complex, involving a mix of proprietary developers, large generics manufacturers, Chinese API producers, and global distribution networks. Originally developed by Eisai, the market now depends heavily on API suppliers like Teva and Chinese pharmaceutical companies, supplemented by regional formulators and distributors. Ensuring supply chain resilience, maintaining high-quality standards, and navigating regulatory landscapes remain critical components for stakeholders in Aciphex’s global market.

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Key Takeaways

• Diversification of API Suppliers: To mitigate risks, manufacturers rely on multiple API producers, notably Eisai, Teva, and Chinese firms like Zhejiang Huahai.

• Patent Expiry Drives Generic Production: The expiration of Aciphex’s patents has expanded the supplier base, increasing market competition and supply options.

• Regulatory Compliance is Critical: Suppliers adhering to GMP standards are favored, ensuring uninterrupted supply and market trust.

• Supply Chain Resilience: Recent global disruptions have underscored the importance of diversified sourcing and robust logistics for consistent drug availability.

• Strategic Partnerships Influence Market Dynamics: Long-term licensing agreements and quality assurances shape supplier relationships and market stability.

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FAQs

1. Who are the primary API suppliers for Aciphex?
Eisai, Teva Pharmaceuticals, and various Chinese API manufacturers like Zhejiang Huahai are the main suppliers producing rabeprazole sodium, the active ingredient in Aciphex.

2. How does patent expiry impact Aciphex’s supply chain?
Patent expiry opens the market to multiple generic manufacturers, increasing API supplier diversity and manufacturing capacity, which enhances supply stability but also intensifies market competition.

3. Are there quality concerns with Chinese API suppliers?
While many Chinese firms like Zhejiang Huahai maintain rigorous GMP standards, regulatory agencies often scrutinize Chinese API producers, emphasizing the importance of compliance and quality assurance processes.

4. What role do contract manufacturers play in Aciphex production?
CMOs handle formulation, tablet compression, and packaging, allowing brands and generics to scale production efficiently while focusing on quality control and regulatory compliance.

5. How is supply chain resilience maintained amidst global disruptions?
Manufacturers diversify API sources, build strategic stockpiles, and optimize logistics networks to mitigate risks associated with geopolitical issues, pandemics, and supply chain interruptions.

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References

1. [1] Eisai Co., Ltd. Annual Reports and Product Portfolio.
2. [2] Teva Pharmaceuticals Annual Reports.
3. [3] Zhejiang Huahai Pharmaceutical GMP Certifications.
4. [4] U.S. Food and Drug Administration (FDA) Title 21 CFR Part 211.
5. [5] European Medicines Agency (EMA) Guidelines on API manufacturing.