Bulk Pharmaceutical API Sources for FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F6889_SIGMA
TCI (Tokyo Chemical Industry)		F0530
Molport		MolPort-002-557-620
Molport		MolPort-003-941-395
Hangzhou APIChem Technology		AC-11713
Vitas-M Laboratory		STK527689

Bulk Active Pharmaceutical Ingredient (API) Sources for FAMOTIDINE, Preservative-Free in Plastic Containers

Last updated: July 30, 2025

Introduction

Famotidine, a histamine-2 (H2) receptor antagonist, is widely utilized to treat conditions like gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and peptic ulcers. As a potent therapeutic agent, famotidine’s quality, purity, and stability are critically dependent on sourcing high-grade APIs. This demand intensifies when considering preservative-free formulations packaged in plastic containers, which necessitate APIs that are compatible with multiple excipients and packaging materials.

The global market for famotidine APIs is characterized by a handful of reputable, compliant manufacturers who adhere to international regulatory standards such as the U.S. FDA, EMA, and WHO GMP guidelines. This report explores the key sources suitable for pharmaceutical companies seeking quality famotidine APIs for preservative-free formulations in plastic containers.

Regulatory and Quality Considerations for API Sourcing

Before identifying suppliers, it is vital to consider several criteria:

• Regulatory Compliance: Suppliers must possess valid manufacturing and GMP certifications (FDA, EMA, ISO).

• API Purity & Specification: API batches should meet pharmacopeial standards (USP/NF, JP, EP) with specified purity (>99%), chloride content, residual solvents, heavy metals, and other impurities.

• Stability & Compatibility: APIs must demonstrate stability without preservatives, compatible with plastic packaging, and free from substances that could catalyze degradation.

• Supply Reliability: Consistent supply chains and capacity for bulk orders are critical.

• Documentation & Support: Suppliers should provide comprehensive batch documentation, stability data, and technical support for formulation development.

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Major Global API Suppliers for Famotidine

1. X (e.g., Shandong Xinhua Pharmaceutical Co., Ltd. [1])

• Overview: Chinese pharmaceutical manufacturers such as Shandong Xinhua Pharmaceutical possess extensive experience in large-scale API production, including famotidine.

• Certifications: GMP, ISO 9001, and export certifications compliant with international standards.

• Strengths: Competitive pricing, large capacity, and proven track record with exportation to North America, Europe, and Asia.

• Capabilities: Production of high-purity famotidine API suitable for preservative-free formulations packaged in plastic containers.

2. Y (e.g., Hikma Pharmaceuticals UAE [2])

• Overview: Hikma's API manufacturing division supplies high-quality APIs globally. Their famotidine API complies strictly with pharmacopeial standards.

• Certifications: FDA-verified manufacturing facilities, GMP compliance.

• Strengths: Robust quality systems, reliable supply chain, and technical support.

• Use Case: Suitable for formulations requiring preservative-free stability due to adherence to strict purity standards.

3. Z (e.g., Sun Pharmaceutical Industries Ltd. [3])

• Overview: As one of India’s leading API manufacturers, Sun Pharma offers famotidine with a focus on high purity, process optimization, and global GMP standards.

• Certifications: WHO-GMP, FDA, and European certifications.

• Strengths: Cost-effective solutions, proven stability profiles, and flexibility for customized quantities.

4. A (e.g., Zhejiang Kangsheng Pharmaceutical Co., Ltd. [4])

• Overview: Chinese API producer specializing in gastrointestinal APIs, including famotidine.

• Certifications: GMP, ISO 9001, and recognized export certifications.

• Strengths: Emphasis on clean synthesis processes, resulting in API suitable for preservative-free formulations.

5. International API Distributors

• a. WuXi AppTec [5]: A leading contract manufacturer and distributor offering high-quality famotidine APIs globally.

• b. Dandong Yisheng Pharmaceutical Co., Ltd. [6]: Certified in GMP and capable of supplying bulk API fitting for preservative-free applications.

• c. ChemPartner [7]: Provides APIs with robust documentation and technical support.

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Criteria for Selecting API Suppliers for Preservative-Free Formulations

When sourcing famotidine APIs specifically for preservative-free formulations in plastic containers, consider:

• API Compatibility: Confirm the chemical stability of famotidine when stored in plastic containers without preservatives. Suppliers should provide stability data indicating long-term performance in such conditions.

• Impurity Profile: Choose APIs with minimal residual solvents and impurities that could interact adversely with plastic packaging or compromise product stability.

• Supply Chain Flexibility: Ensure scalable and timely supply to facilitate manufacturing demands.

• Documentation & Validation Data: Detailed certificates of analysis (CoA), stability reports, and processing documentation support regulatory submissions and quality assurance.

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Emerging Trends and Considerations

• Manufacturing in China and India: Increasing production capacities and strict adherence to international standards make Asian suppliers attractive options.

• Quality vs. Cost Balance: While cost-efficiency is appealing, ensuring compliance with global regulations and stability data takes precedence, especially for preservative-free formulations.

• Regulatory Pathways: Using APIs sourced from certified suppliers can streamline regulatory approvals, provided documentation aligns with country-specific requirements.

• Packaging Compatibility: Advanced testing to confirm API stability in plastic containers—particularly in preservative-free settings—is crucial and should be validated during sourcing.

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Conclusion

Securing high-quality bulk famotidine API sources is foundational for manufacturing preservative-free formulations in plastic containers. Reliable suppliers—such as Shandong Xinhua Pharmaceutical, Hikma Pharmaceuticals, and Sun Pharma—offer compliant APIs with the necessary purity and stability profiles. The decision should prioritize certifications, stability data, and supply reliability aligned with regulatory standards and formulation requirements.

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Key Takeaways

• Regulatory compliance and high API purity are non-negotiable in sourcing famotidine for preservative-free, plastic-packaged products.

• Asian manufacturers, notably Chinese and Indian suppliers, dominate the market with scalable, GMP-compliant facilities.

• Stability data and impurity profiles are critical considerations due to the absence of preservatives and packaging in plastic containers.

• Establishing reliable supply chains with flexibility for large orders ensures production continuity and regulatory compliance.

• Thorough qualification and validation are essential, including testing API compatibility with plastic packaging and ensuring long-term stability without preservatives.

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FAQs

1. What are the most recognized global suppliers for famotidine API?
Leading suppliers include Shandong Xinhua Pharmaceutical, Hikma Pharmaceuticals (UAE), and Sun Pharmaceutical Industries, all offering GMP-compliant, high-purity APIs suitable for pharmaceutical use.

2. How does preservative-free formulation influence API selection?
APIs must possess high chemical stability and purity to ensure long shelf life without preservatives, especially in plastic containers where interactions could occur.

3. What quality certifications should an API supplier ideally hold?
Suppliers should have GMP certification from recognized authorities (FDA, EMA, WHO), alongside ISO 9001 and relevant pharmacopeial standards (USP/NF, EP, JP).

4. Are there specific stability considerations for famotidine in plastic containers?
Yes. Stability data should confirm that famotidine maintains potency and purity over the intended shelf life in plastic, preservative-free environments.

5. How can a pharmaceutical company validate an API’s suitability for preservative-free, plastic-packaged formulations?
Through comprehensive stability studies, impurity profiling, compatibility testing with plastic materials, and review of batch documentation provided by the supplier.

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References

[1] Shandong Xinhua Pharmaceutical Co., Ltd. Official Website.
[2] Hikma Pharmaceuticals. API Product List.
[3] Sun Pharmaceutical Industries Ltd. API Quality Data.
[4] Zhejiang Kangsheng Pharmaceutical Co., Ltd. API Profile.
[5] WuXi AppTec. API Manufacturing Capabilities.
[6] Dandong Yisheng Pharmaceutical Co., Ltd. GMP Certification.
[7] ChemPartner. API Development and Supply.