Bulk Pharmaceutical API Sources for ACIPHEX SPRINKLE

Bulk Pharmaceutical API Sources for ACIPHEX SPRINKLE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-098
Molport		MolPort-003-986-282
Hangzhou APIChem Technology		AC-715
Amadis Chemical		A803857
AKos Consulting & Solutions		AKOS015895734

Bulk Active Pharmaceutical Ingredient (API) Sources for: ACIPHEX SPRINKLE

Last updated: July 28, 2025

Introduction

Aciphex Sprinkle, the marketed formulation of the proton pump inhibitor rabeprazole sodium, is prescribed primarily for gastroesophageal reflux disease (GERD) and other related acid-related disorders. As a specialized pharmaceutical product, the manufacturing of Aciphex Sprinkle hinges critically on sourcing high-quality bulk Active Pharmaceutical Ingredient (API) — rabeprazole sodium. Ensuring access to reliable, GMP-compliant API suppliers is pivotal for pharmaceutical firms aiming to maintain quality, regulatory compliance, and supply chain resilience.

Overview of Rabeprazole Sodium API

Rabeprazole sodium, the API utilized in Aciphex Sprinkle, inhibits gastric proton pumps, reducing acid secretion. The API's purity, stability, and conforming specifications directly influence the efficacy and safety of the finished product. Consequently, sourcing this API involves vetting suppliers for robust manufacturing quality, regulatory credentials, and capacity to deliver at scale.

Global API Manufacturers for Rabeprazole Sodium

The following outlines the principal sources of rabeprazole sodium API, categorized based on their geographic origins, regulatory standing, and production capabilities.

1. Major Indian API Manufacturers

India remains a dominant global supplier of generic APIs, including rabeprazole sodium. Several Indian pharmaceutical API producers have developed extensive manufacturing expertise, scalable production capacities, and GMP compliance.

• SS Organics / S S Active Pharmeceuticals
  Located in Gujarat, they are a recognized API manufacturer with consistent GMP accreditation. Their facilities are equipped to produce rabeprazole sodium at both small and large scales, adhering to international quality standards.

• Hetero Labs Ltd.
  Based in Hyderabad, Hetero offers a vertically integrated API manufacturing process, with robust GMP certifications and global regulatory approvals supporting exports to markets like the US, Europe, and emerging markets.

• Glenmark Pharmaceuticals
  As a major Indian producer, Glenmark provides high-quality rabeprazole sodium API, with a focus on stringent quality controls, cGMP compliance, and a sizable export footprint.

• Aarti Drugs Ltd.
  A publicly traded Indian API manufacturer with an established portfolio of proton pump inhibitors, including rabeprazole sodium, certified under various regulatory frameworks.

2. Chinese API Manufacturers

China's API industry remains vital, driven by competitive pricing and large production capacities, though regulatory and quality variances are scrutinized more rigorously.

• Hepeng Pharmaceutical Co. Ltd.
  Located in Zhejiang Province, Hepeng produces rabeprazole sodium API with GMP certification and supplies both domestic and international markets.

• Luye Pharma Group
  Notable for high manufacturing standards, Luye’s Chinese facilities are GMP-certified, serving global markets with consistent API quality.

• Jiangsu Hiler Pharmaceuticals
  An emerging API supplier with approved GMP facilities producing rabeprazole sodium, focused on compliance with international standards.

3. European and North American API Suppliers

While less prevalent in the primary manufacturing of rabeprazole sodium, some European, Canadian, and US-based facilities provide high-purity APIs, often catering to niche or highly regulated markets.

• Siegfried AG (Switzerland)
  Known for custom synthesis and high-potency APIs, Siegfried offers rabeprazole sodium with comprehensive quality management.

• NorthWest Pharma (Canada)
  Specializes in APIs meeting North American regulatory standards, including rabeprazole sodium, for pharmaceutical companies seeking domestically sourced APIs.

4. Regulatory and Quality Considerations

Supplier selection hinges on several critical factors:

• GMP Compliance: Ensures manufacturing adheres to Good Manufacturing Practices, vital for regulatory approvals in regions such as the US FDA, EUDRALEX, and Health Canada.

• Regulatory Approvals: Suppliers with approved ANDA, CEP, DMF, or equivalent dossiers facilitate faster regulatory clearance.

• Quality Certifications: ISO certifications, batch-to-batch consistency, validated analytical methods, and comprehensive stability data underpin supplier credibility.

• Capacity and Lead Times: Suppliers capable of consistent supply volume and reliable lead times mitigate risk of shortages.

5. Supply Chain Challenges and Risks

While Indian and Chinese API manufacturers dominate, geopolitical tensions, trade restrictions, or quality concerns can impact sourcing strategies. Therefore, diversification among reputable suppliers from different regions and maintaining dual or tertiary sources enhance supply chain resilience.

Conclusion

Sourcing rabeprazole sodium API for Aciphex Sprinkle demands meticulous supplier vetting to ensure quality, compliance, and reliable supply. Indian giants like Hetero, Glenmark, and Aarti Drugs, alongside trusted Chinese producers such as Hepeng Pharmaceutical, form the core of the global supply network. Engagements with European and North American API producers further bolster supply security, especially for markets with stringent regulatory expectations.

Key Takeaways

• Indian APIs dominate the rabeprazole sodium market, supported by robust GMP compliance and competitive pricing.
• Chinese manufacturers provide large capacities at competitive costs but require rigorous quality validation.
• Extensive due diligence on regulatory compliance, quality certifications, and supply continuity is vital.
• Diversifying API sources mitigates geopolitical and supply chain risks.
• Early engagement with suppliers possessing approved dossiers accelerates regulatory approval processes.

FAQs

1. What are the primary considerations when sourcing rabeprazole sodium API for Aciphex Sprinkle?
Regulatory compliance (GMP), high purity standards, consistent quality, supply capacity, and supplier reputation are critical.

2. How does supplier regulation impact API sourcing?
Suppliers with approved DMF, CEP, or ANDA dossiers streamline regulatory submissions and reduce approval timelines in target markets.

3. Are Indian API manufacturers reliable for pharmaceutical-grade rabeprazole sodium?
Yes, leading Indian manufacturers such as Hetero and Glenmark maintain GMP compliance and have extensive export experience, ensuring quality and reliability.

4. What are the risks associated with Chinese API suppliers?
Risks include variable quality standards and regulatory nuances; thorough qualification audits and testing are essential before partnership.

5. How can companies mitigate supply disruptions in API sourcing?
By diversifying suppliers across regions, establishing multiple procurement channels, and maintaining safety stock levels.

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References

1. [1] U.S. FDA Database on API Suppliers and DMFs.
2. [2] European Medicines Agency (EMA) Certificate of Suitability (CEP) Directory.
3. [3] Indian Pharmaceutical Alliance and Manufacturing Data.
4. [4] Chinese GMP Certification Reports.
5. [5] Pharma Intelligence Market Reports on Global API Supply Chains.