Bulk Pharmaceutical API Sources for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for PEPCID 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 Pepcid (Famotidine) Preservative-Free in Plastic Container

Last updated: July 31, 2025

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Introduction

Famotidine, marketed under the brand name Pepcid, is a widely used H2 receptor antagonist indicated for treating conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. The pharmaceutical formulation, particularly preservative-free variants packaged in plastic containers, caters to patients with sensitivities or allergies to preservatives and ensures stability and compatibility with specific medical protocols.

Identifying reliable bulk API sources for famotidine suitable for manufacturing preservative-free formulations in plastic containers demands precision, quality assurance, and adherence to regulatory standards. This detailed analysis explores the global landscape, key suppliers, sourcing considerations, and regulatory compliance critical to procurement decisions.

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1. Overview of API Specifications for Pepcid (Famotidine)

For pharmaceutical applications, famotidine API must meet stringent specifications set by pharmacopoeias like USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). Critical parameters include:

• Assay purity typically ≥98%
• Impurity limits aligned with pharmacopeia standards
• Residual solvents and elemental impurities within permissible limits
• Absence of preservatives, preservatives must be added during formulation
• Stability suitable for preserved or preservative-free formulations in plastics

Selecting APIs that are labeled as preservative-free and compatible with plastic packaging minimizes risk of leaching, contamination, and stability issues.

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2. Global API Suppliers for Famotidine

Several globally recognized API manufacturers supply famotidine at pharmaceutical-grade levels suitable for formulating preservative-free preparations:

A. Leading Manufacturers and Suppliers

• Shanghai Fosun Pharmaceutical Co., Ltd. (China)
  A prominent API manufacturer with ISO, cGMP certification, offering famotidine in bulk quantities. Fosun’s APIs meet international standards, with extensive supply capacity for global partners.

• Sun Pharmaceutical Industries Ltd. (India)
  One of the world's largest API producers, Sun Pharma supplies famotidine API meeting USP/EP standards. They maintain rigorous quality controls suitable for preservative-free applications.

• Teva Pharmaceutical Industries Ltd. (Israel)
  Known for their high-quality generics and APIs, Teva offers famotidine API with a focus on purity, consistent supply, and cGMP compliance.

• TAPI LLC (India)
  A credible supplier specializing in APIs, including famotidine, adhering to international quality certifications and providing documentation on impurity profiles and stability data.

• Piramal Enterprises (India)
  A notable API supplier with a diverse portfolio and compliance certificates supporting pharmaceutical-grade famotidine APIs.

B. Contract Development and Manufacturing Organizations (CDMOs)

• BASF, Evonik, or Cambrex
  Major CMOs capable of producing custom famotidine APIs, ensuring preservation of active capacity and standard compliance, with added flexibility for formulations like preservative-free in plastics.

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3. Sourcing Considerations for Preservative-Free Formulations in Plastic Containers

When sourcing APIs for preservative-free Pepcid formulations, manufacturers must prioritize:

• API Purity and Compatibility
  The API must be of high purity with minimal impurities to ensure chemical stability and compatibility with plastic packaging. Certain preservatives or stabilizers incompatible with plastics should be avoided.

• Certifications and Compliance
  Supply should include documentation for cGMP adherence, coA (Certificate of Analysis), stability data, and absence of preservatives or stabilizing agents that could leach from plastics.

• Quality Control and Testing
  Rigorously evaluate API batch testing reports focusing on heavy metals, residual solvents, and impurity profiles suitable for preservative-free solutions.

• Supply Chain Reliability
  Consistent supply, contingency planning, and responsiveness to demand fluctuations are crucial, especially for APIs supplied from geographically diverse sources amid global supply chain disruptions.

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4. Regulatory and Documentation Requirements

Regulators and end-users emphasize:

• Batch Certification and Certificates of Analysis (CoA)
  Detailing purity, impurity limits, residual solvents, and compliance with pharmacopoeia standards.

• Stability Data
  Demonstrating API suitability for incorporation into preservative-free formulations, particularly in plastic containers, with data on chemical stability over shelf life.

• Material Compatibility Data
  Confirming that the API and final formulation do not interact adversely with plastic packaging, avoiding leaching or degradation.

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5. Regional API Supplier Highlights

Region	Notable Suppliers	Certifications	Focus Points
Asia (India, China)	Sun Pharma, Fosun, Cipla, Jiangsu Hengrui Medicine	cGMP, ISO, WHO GMP	Cost efficiency, large capacity
Europe	Evonik, Sabinsa, Fareva	EMA-approved, cGMP	Higher assurance on quality and stability data
North America	Cambrex, Carbosynth	USP, EP, JP certifications	Advanced quality management

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6. Conclusion

Sourcing API for preservative-free Pepcid in plastic containers demands a strategic selection from reputable global manufacturers capable of delivering high-purity famotidine API aligned with strict standards. The choice of API supplier should be guided by compliance certifications, impurity profile, stability data, and supply chain reliability.

Manufacturers aiming for preservative-free formulations must also consider accompanying stability and compatibility data to ensure product integrity and safety.

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Key Takeaways

• Prioritize suppliers with cGMP certification and rigorous quality control processes capable of providing preservative-free famotidine APIs.
• Evaluate impurity profiles comprehensively, with emphasis on stability and compatibility with plastic containers.
• Maintain thorough documentation, including CoA, stability data, and material compatibility studies to ensure regulatory compliance.
• Engage suppliers capable of steady, reliable supply chains, especially amid global logistics uncertainties.
• Conduct internal validation testing to confirm API quality and compatibility within preservative-free formulations.

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FAQs

1. What are the primary considerations when sourcing famotidine API for preservative-free formulations?
Key factors include API purity, absence of preservatives, stability data, compatibility with plastic packaging, regulatory certifications, and supply reliability.

2. Are there specific regulations governing APIs for preservative-free products?
Yes, APIs must comply with pharmacopeial standards (USP, EP, JP), and manufacturers must provide documentation demonstrating purity, stability, and absence of contaminants or preservatives.

3. Which regions are the leading suppliers of pharmaceutical-grade famotidine API?
India and China are major suppliers, with notable contributions from Europe and North America, offering high-quality APIs with varying cost and regulatory profiles.

4. How does plastic container packaging affect API stability and formulation?
Plastic packaging necessitates APIs that are chemically stable and inert, preventing leaching or interaction that could compromise safety or efficacy, especially in preservative-free formulations.

5. What role do stability and compatibility studies play in API sourcing?
They ensure the API remains stable and effective within the final preservative-free formulation and in plastic containers, reducing degradation risks and ensuring patient safety.

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References

1. United States Pharmacopeia. USP General Chapter <1110> Stability Testing.
2. European Pharmacopoeia. Ph. Eur. Monograph for Famotidine.
3. GlobalData. API Market Trends & Suppliers.
4. Pharmaceutical Technology. Sourcing Strategies for APIs in Preservative-Free Formulations.
5. FDA. Guidelines for Pharmaceutical Packaging Compatibility.