Bulk Pharmaceutical API Sources for GAVISCON

Bulk Pharmaceutical API Sources for GAVISCON

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S623785
THE BioTek		bt-444410
BenchChem		B1233894

Bulk Active Pharmaceutical Ingredient (API) Sources for GAVISCON

Last updated: July 29, 2025

Introduction

GAVISCON, a widely used over-the-counter antacid and gastroesophageal reflux disease (GERD) remedy, primarily comprises active pharmaceutical ingredients (APIs) such as aluminum hydroxide and magnesium hydroxide. As the demand for GAVISCON continues, pharmaceutical companies seek reliable bulk API sources to ensure quality, consistency, and cost-effectiveness. This report analyzes the major suppliers, sourcing trends, and considerations for procuring APIs for GAVISCON manufacturing.

Key APIs in GAVISCON

GAVISCON's efficacy hinges on its antacid properties, which are primarily due to:

• Aluminum Hydroxide (Al(OH)₃): Neutralizes gastric acid, alleviating symptoms.
• Magnesium Hydroxide (Mg(OH)₂): Works synergistically with aluminum hydroxide for rapid and sustained antacid action.

The APIs are supplied in pharmaceutical-grade quality, adhering to stringent regulatory standards.

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Major API Suppliers for GAVISCON

1. Aluminum Hydroxide Suppliers

   • Hubei Jusheng Technology Co., Ltd.
     Located in China, Jusheng supplies pharmaceutical-grade aluminum hydroxide with consistent quality, large production capacity, and competitive pricing. The company is certified under ISO 9001 and adheres to Good Manufacturing Practices (GMP) standards [1].

   • Reynolds Advanced Materials
     Based in the United States, Reynolds offers high-purity aluminum hydroxide with pharmaceutical-grade specifications suitable for antacid formulations. Their APIs meet USP and EP standards, ensuring international compliance [2].

   • Nantong Xingchen Biological Technology Co., Ltd.
     Also based in China, they provide high-quality aluminum hydroxide, emphasizing scalability and regulatory compliance, making them a preferred choice for large-volume producers [3].

2. Magnesium Hydroxide Suppliers

   • Shreeji Chemicals
     An Indian supplier providing pharmaceutical-grade magnesium hydroxide with a focus on purity, bioavailability, and regulatory compliance. They cater primarily to Indian and international markets [4].

   • Gujarat Borosil Ltd.
     Located in India, they manufacture magnesium hydroxide with consistent quality standards, covering both technical and pharmaceutical grades aligned with USP and BP specifications [5].

   • Hubei Jusheng Technology Co., Ltd
     As with aluminum hydroxide, Jusheng supplies magnesium hydroxide in high purity, certified for pharmaceutical applications, with proven scalability [1].

3. Integrated Suppliers and Contract Manufacturers

   Some companies offer both APIs and finished bulk products:

   • BASF
     The German chemical giant supplies pharmaceutical-grade aluminum and magnesium hydroxides, with a focus on customized formulations suitable for antacid products.

   • Capot Chemical Ltd.
     A China-based contract manufacturer offering both APIs and GAVISCON-like formulations, ensuring integration from raw API sourcing to finished product manufacturing [6].

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Sourcing Trends and Considerations

• Regulatory Compliance:
  Suppliers must meet standards such as USP, EP, JP, and BP monographs. Certified APIs ensure that GAVISCON maintains quality and safety standards.

• Quality Assurance:
  Rigorous testing for heavy metals, microbial contamination, moisture content, and purity is essential. Suppliers with ISO/GMP certifications reduce compliance risks.

• Cost and Scalability:
  Manufacturers often balance price with volume capacity. Chinese suppliers generally offer competitive pricing due to large-scale production but require thorough quality audits.

• Supply Chain Robustness:
  Long-term partnerships with diversified suppliers mitigate risks like geopolitical issues, trade restrictions, and raw material shortages.

• Environmental and Ethical Standards:
  Suppliers committed to environmental sustainability and ethical practices are increasingly preferred, aligning with global pharma corporate social responsibility policies.

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Regional Sourcing Insights

• Asia-Pacific: Dominant due to cost advantage, with China and India leading in API manufacturing capacity.
• Europe and North America: Smaller but high-quality suppliers focusing on compliance and specialized markets.
• Emerging Markets: Increasing investments in API manufacturing facilities to meet local demand and reduce dependence on imports.

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Regulatory and Supply Chain Challenges

• Regulatory Hurdles: Variance in regional standards necessitates comprehensive documentation and validation.
• Supply Disruptions: Dependence on a limited number of suppliers may cause shortages; hence, dual sourcing is recommended.
• Quality Consistency: Variability across batches can impact GAVISCON efficacy, emphasizing the importance of rigorous QC processes.

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Strategic Recommendations

• Partner with certified suppliers possessing GMP, ISO, and regulatory approvals.
• Implement dual sourcing strategies to mitigate supply disruptions.
• Conduct regular audits and quality assessments.
• Establish long-term collaborations to ensure stable supply and potential cost benefits.
• Stay informed on regulatory changes impacting API import/export and manufacturing standards.

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Key Takeaways

• Reliable sourcing of aluminum hydroxide and magnesium hydroxide is critical for GAVISCON production.
• Chinese and Indian suppliers dominate due to cost and capacity advantages but require thorough validation.
• Regulatory compliance, quality assurance, and supply chain resilience are paramount considerations.
• Developing diversified supplier relationships mitigates risks and ensures continuity.
• Continuous monitoring of regulatory standards and supplier performance enhances supply chain robustness.

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FAQs

1. What are the primary considerations when sourcing APIs for GAVISCON?
Regulatory compliance, quality assurance, supplier reputation, cost, scalability, and supply chain stability are essential factors.

2. Which countries are leading suppliers of pharmaceutical-grade aluminum and magnesium hydroxides?
China and India are the leading suppliers, offering high capacity and competitive pricing, while Europe and North America focus on high-quality, certified APIs.

3. How do regulatory standards influence API sourcing?
APIs must meet regional standards like USP, EP, BP, or JP, involving rigorous testing and documentation to ensure safety and efficacy compliance.

4. Can I source APIs directly from manufacturers or through intermediaries?
Both options are viable. Direct sourcing offers cost advantages but requires thorough due diligence; intermediaries can simplify logistics but may add costs.

5. What are the risks associated with API supply chains for GAVISCON?
Risks include supply disruptions, regulatory non-compliance, quality variability, geopolitical issues, and environmental or ethical concerns.

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References

[1] Hubei Jusheng Technology Co., Ltd., company website, accessed 2023.
[2] Reynolds Advanced Materials, API product datasheet, 2022.
[3] Nantong Xingchen Biological Technology Co., Ltd., regulatory compliance documentation, 2023.
[4] Shreeji Chemicals, product catalog, 2023.
[5] Gujarat Borosil Ltd., API manufacturing overview, 2022.
[6] Capot Chemical Ltd., contract manufacturing capabilities, 2023.