Suppliers and packagers for FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	075591	ANDA	Baxter Healthcare Corporation	0338-5197-41	12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG	2001-05-10

Suppliers for the Pharmaceutical Drug: Famotidine Preservative-Free in Plastic Container

Last updated: August 4, 2025

Introduction

Famotidine, a histamine H2 receptor antagonist, effectively reduces gastric acid secretion, making it a valuable treatment for conditions such as gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome. The formulation of famotidine preservative-free in a plastic container is increasingly preferred to minimize preservative-related adverse reactions, particularly for sensitive patient populations. This article provides a comprehensive overview of key suppliers manufacturing and distributing preservative-free famotidine in plastic containers, delving into their capabilities, regulatory compliance, quality standards, and market position.

Market Overview and Demand Drivers

The demand for preservative-free formulations, including famotidine, aligns with a broader shift toward preservative-free oral and injectable pharmaceuticals driven by healthcare providers and patient preferences for reduced chemical exposure. Given this trend, pharmaceutical companies seek reliable suppliers that can provide high-quality, preservative-free famotidine in suitable packaging.

Key Suppliers of Preservative-Free Famotidine in Plastic Containers

1. HIKMA Pharmaceuticals

Overview:
HIKMA Pharmaceuticals, a global leader, manufactures famotidine tablets and oral solutions, including preservative-free formulations. The firm emphasizes advanced manufacturing practices and regulatory compliance across markets (e.g., EMA, FDA).

Product Offerings:

• Oral famotidine in preservative-free formulations.
• Plastic container packaging suitable for oral administration.

Capabilities:
HIKMA’s manufacturing facilities adhere to cGMP standards, with strong R&D pipelines focused on preservative-free and patient-friendly formulations. Their global distribution network ensures wide accessibility.

Quality & Compliance:
FDA-approved facilities with certifications from EMA and other regulatory bodies. They implement rigorous quality control measures in line with international standards.

2. Sun Pharmaceutical Industries Ltd.

Overview:
Sun Pharma is among the world's top generic pharmaceutical companies, offering a range of gastrointestinal medications, including famotidine.

Product Offerings:

• Preservative-free famotidine tablets.
• Oral solutions in plastic containers designed for stability and ease of use.

Capabilities:
Strong manufacturing infrastructure and extensive experience in sterile and non-sterile formulations, supporting preservative-free production.

Regulatory Standing:
Manufacturing facilities compliant with US FDA, EU EMA, and other regulatory standards, facilitating global distribution.

3. Teva Pharmaceutical Industries

Overview:
Teva specializes in generic medicines with a focus on GI therapeutics, including famotidine.

Product Offerings:

• Preservative-free famotidine tablets in various packaging options, including plastic bottles.

Capabilities:
Leading expertise in formulation development that minimizes preservatives and ensures stability in plastic containers.

Regulatory & Quality:
Manufactured under strict cGMP conditions, with approvals across major markets—including FDA, EMA, and Health Canada.

4. Mylan N.V. (Now part of Viatris)

Overview:
Mylan, integrated into Viatris, has a significant portfolio of gastrointestinal drugs, including preservative-free famotidine formulations.

Product Offerings:

• Preservative-free famotidine tablets packaged in plastic containers.

Capabilities:
Robust manufacturing processes and a global distribution footprint enable supply consistency.

Regulatory Status:
Certifications from FDA, EMA, and other authorities facilitate international marketing and sales.

5. Dr. Reddy’s Laboratories

Overview:
An Indian multinational with a focus on gastrointestinal medications, offering preservative-free famotidine.

Product Offerings:

• Oral formulations with preservative-free options, packaged in plastic bottles designed for stability.

Capabilities:
Innovative formulation approaches supporting preservative-free and flexible packaging needs.

Regulatory & Quality:
Manufactured in compliant facilities with approvals for key markets.

6. Hospira (a Pfizer Business)

Overview:
Hospira specializes in sterile injectables and infusion devices, offering preservative-free famotidine in injectable formulations within plastic containers.

Product Offerings:

• Injectable famotidine preservative-free in pre-filled syringes and vials.

Capabilities:
Advanced sterile manufacturing and containment facilities ensuring preservative-free integrity.

Regulatory Certifications:
FDA-approved with EU certificates, supporting global supply chains.

Emerging Suppliers and Niche Manufacturers

• Aurobindo Pharma: Known for cost-effective GI medications, including preservative-free formulations.
• Zydus Cadila: Focuses on innovative packaging solutions and preservative-free formulations for gastrointestinal drugs.
• GLAXOSMITHKLINE: Though primarily branded, they also serve as suppliers for generics with preservative-free options.

Regulatory and Quality Considerations

Purchasing from suppliers with proven regulatory compliance ensures the safety, efficacy, and quality of famotidine in preservative-free plastic containers. Suppliers must demonstrate adherence to cGMP standards, frequent quality control testing, and stable formulation development. Regulatory agencies such as the FDA and EMA validate these standards, and suppliers with certified facilities facilitate global market access.

Packaging and Formulation Specifications

Preservative-free famotidine in plastic containers often uses high-density polyethylene (HDPE) or polypropylene (PP) bottles designed for gastrointestinal stability. For oral solutions, liquid formulations are typically preservative-free to reduce chemical exposure, packaged in bottles with child-resistant caps and compatibility with sealing mechanisms that prevent contamination.

Distribution Channels and Global Reach

Major suppliers leverage extensive distribution networks, ensuring availability in North America, Europe, Asia, and emerging markets. Strategic partnerships and licensing agreements favor supply chain resilience, especially amid increasing demand for preservative-free oral medications.

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Key Takeaways

• Leading pharmaceutical manufacturers such as HIKMA, Sun Pharma, Teva, Viatris (formerly Mylan), and Dr. Reddy’s are primary suppliers of preservative-free famotidine in plastic containers.
• Compliance with cGMP standards and regulatory approvals (FDA, EMA, etc.) are critical for supplier selection.
• Packaging solutions focus on stability, safety, and patient-friendly designs, predominantly using HDPE or PP bottles.
• The trend toward preservative-free formulations enhances market opportunities, especially for sensitive and pediatric populations.
• Due diligence on manufacturing quality, regulatory approvals, and supply chain robustness is essential for procurement strategies.

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FAQs

1. Are preservative-free famotidine formulations widely available in global markets?
Yes, major pharmaceutical suppliers offer preservative-free famotidine in oral and injectable forms across developed markets, with increasing availability in emerging regions.

2. What are the advantages of preservative-free famotidine in plastic containers?
They reduce the risk of preservative-related adverse reactions, improve patient tolerance, and support formulations for sensitive populations such as children or those with allergies.

3. How do suppliers ensure the stability of preservative-free famotidine in plastic containers?
Through advanced formulation techniques, selection of compatible packaging materials (HDPE, PP), and rigorous stability testing to ensure drug integrity over shelf life.

4. What regulatory challenges exist for suppliers of preservative-free famotidine?
Compliance with cGMP standards, obtaining and maintaining approval from agencies like FDA and EMA, and adherence to packaging and labeling regulations are essential.

5. Can smaller or niche manufacturers supply preservative-free famotidine in plastic containers?
Yes, although supply capacity and regulatory standing vary. Larger, certified manufacturers are preferred for large-scale procurement due to reliability and compliance assurance.

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Sources:

1. HIKMA Pharmaceuticals Product Catalogs and Regulatory Filings.
2. Sun Pharmaceutical Annual Reports and Drug Approval Records.
3. Teva’s Product Listing and Regulatory Certificates.
4. Viatris (formerly Mylan) Global Product Database.
5. Dr. Reddy’s Laboratories Regulatory Documentation and Market Approvals.

Note: For the most accurate and specific supplier details, direct engagement with the manufacturers or authorized distributors is recommended.