CEFTRIAXONE IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	CEFTRIAXONE IN PLASTIC CONTAINER	ceftriaxone sodium	INJECTABLE;INJECTION	065224	ANDA	Baxter Healthcare Company	0338-5002-41	24 BAG in 1 CASE (0338-5002-41) / 50 mL in 1 BAG	2005-08-23
Baxter Hlthcare	CEFTRIAXONE IN PLASTIC CONTAINER	ceftriaxone sodium	INJECTABLE;INJECTION	065224	ANDA	Baxter Healthcare Company	0338-5003-41	24 BAG in 1 CASE (0338-5003-41) / 50 mL in 1 BAG	2005-08-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

Ceftriaxone, a third-generation cephalosporin antibiotic, is widely prescribed to treat serious bacterial infections due to its broad-spectrum efficacy. Its packaging in plastic containers ensures stability, safety, and ease of administration. The quality and reliability of suppliers are critical for manufacturers, healthcare providers, and distributors aiming to meet global standards for pharmaceutical safety and efficacy. This article provides a comprehensive overview of key suppliers specializing in the production and supply of ceftriaxone in plastic containers, focusing on their manufacturing capabilities, regulatory compliance, global reach, and competitive advantages.

Understanding Ceftriaxone in Plastic Containers

Ceftriaxone is typically supplied as a sterile powder or pre-filled solution in vials, ampoules, or plastic containers. The choice of plastic container—often polyethylene or polypropylene—is based on chemical compatibility, barrier properties, and regulatory standards. Plastic containers facilitate easier handling, reduce breakage risk, and support pre-filled formulations for intravenous administration, improving patient safety and operational efficiency.

The manufacturing of ceftriaxone in plastic containers involves rigorous processes to ensure sterility, stability, and precise dosing. Suppliers must adhere to stringent good manufacturing practices (GMP) outlined by regulatory agencies such as the FDA, EMA, and WHO.

Major Global Suppliers of Ceftriaxone in Plastic Containers

1. Hospira (Pfizer Inc.)

Overview: Hospira, acquired by Pfizer in 2015, remains a key global supplier of injectable antibiotics, including ceftriaxone. They produce ready-to-use solutions and powder formulations in plastic containers designed for hospital use and outpatient clinics.

Capabilities: Hospira’s manufacturing facilities operate under strict GMP standards, producing high-quality, sterile ceftriaxone in various plastic containers, including pre-filled syringes and vials. Their distribution network spans North America, Europe, and emerging markets.

Regulatory Compliance: Their products have approved filings with the FDA and EMA, ensuring compliance with international standards.

2. Sandoz (Novartis)

Overview: Sandoz, a division of Novartis, is a leading manufacturer of generic injectable medicines, including ceftriaxone in plastic containers. Known for cost-effective yet quality-assured solutions, Sandoz caters to global markets.

Capabilities: Their manufacturing facilities are compliant with GMP and possess extensive experience in sterile manufacturing. They offer ceftriaxone in plastic vials and pre-filled syringes suitable for hospital and outpatient settings.

Regulatory Compliance: Sandoz maintains a robust portfolio of regulatory approvals, including WHO-prequalified products, facilitating access in developing countries.

3. Teva Pharmaceuticals

Overview: Teva is one of the largest generic drug manufacturers worldwide, providing ceftriaxone in plastic formulations in various markets.

Capabilities: With manufacturing units adhering to GMP, Teva supplies ceftriaxone in plastic bags, vials, and pre-filled syringe formats, ensuring supply chain robustness.

Regulatory Compliance: Their products are approved by multiple agencies, including FDA, EMA, and local regulatory authorities, emphasizing quality and safety.

4. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion technologies and sterile injectables, including ceftriaxone in plastic containers tailored for intravenous administration.

Capabilities: Their manufacturing facilities operate under GMP standards, producing pre-filled syringes and infusion bags that incorporate ceftriaxone.

Regulatory Compliance: Their products have global approvals, including WHO PQ (Prequalification) status, ensuring suitability for international procurement.

5. Cipla

Overview: Cipla is a prominent Indian pharmaceutical company offering affordable injectable antibiotics, including ceftriaxone in plastic containers.

Capabilities: Their manufacturing plants are GMP certified, and they produce ceftriaxone as powders and pre-filled solutions for the domestic and export markets.

Regulatory Compliance: Cipla’s products meet multiple international standards, and they hold approvals from the drug authorities of several countries.

Regional Suppliers and Market Dynamics

Apart from global giants, regional manufacturers play significant roles, especially in emerging markets where local production aligns with regional regulatory standards. Countries like India, China, and Turkey host numerous GMP-certified manufacturers offering ceftriaxone in various plastic packaging formats. These suppliers often provide cost-effective options, making them vital for procurement in resource-constrained healthcare settings.

Key Criteria for Selecting a Ceftriaxone Supplier

Regulatory Approvals: Ensure compliance with relevant national and international agencies (FDA, EMA, WHO).
Manufacturing Standards: Confirm GMP certification and adherence to sterility, stability, and packaging quality.
Packaging Compatibility: Verify the suitability of plastic containers (polyethylene, polypropylene) for ceftriaxone formulations.
Supply Chain Reliability: Assess logistics capabilities, lead times, and capacity to meet demand fluctuations.
Pricing and Cost Efficiency: Balance quality with cost-effectiveness, especially for large-volume procurement.
Product Portfolio: Consider suppliers offering complementary formulations for integrated treatment protocols.

Regulatory and Quality Considerations

Suppliers must demonstrate compliance with GMP to ensure pharmaceutical quality. The sterile manufacturing environment, validation protocols, and quality control processes are critical for preventing contamination or stability issues. Additionally, suppliers with WHO prequalification or CE marking are preferred for global health initiatives and tenders.

Emerging Trends and Future Outlook

The demand for ceftriaxone in plastic containers is expected to rise, driven by the growing burden of bacterial infections and the need for hospital-ready injectable antibiotics. Innovations focus on pre-filled syringe formats, single-dose packaging, and improved stability in plastic containers to enhance safety and convenience. Manufacturers investing in technologically advanced, ISO-certified facilities will sustain competitive advantages.

Moreover, strategic collaborations and licensing agreements enable access to high-quality ceftriaxone formulations across various markets, ensuring broad availability.

Conclusion

Sourcing ceftriaxone in plastic containers demands careful consideration of supplier capability, regulatory status, and logistical reliability. Leading multinational companies like Pfizer’s Hospira, Novartis’s Sandoz, Teva, Fresenius Kabi, and Cipla dominate the landscape with robust manufacturing infrastructure and regulatory approvals. Regional producers also serve crucial roles, particularly in emerging markets. Selecting the right supplier aligns with compliance standards, cost considerations, and supply chain resilience, ensuring consistent availability of this essential antibiotic.

Key Takeaways

Global giants such as Hospira (Pfizer), Sandoz (Novartis), Teva, Fresenius Kabi, and Cipla are primary suppliers of ceftriaxone in plastic containers.
Rigorous GMP compliance and international regulatory approvals are essential for supplier qualification.
Plastic container formats—vials, pre-filled syringes, and infusion bags—enhance safety and operational efficiency.
Regional manufacturers provide cost-effective options, especially for emerging market requirements.
Future growth hinges on innovation in packaging and manufacturing technologies to meet increasing global demand.

FAQs

Q1: What are the most recognized certifications to verify a ceftriaxone supplier’s credibility?
A1: Major certifications include GMP compliance, WHO prequalification, ISO standards, and approvals from regulatory authorities like the FDA and EMA.

Q2: How do plastic containers affect the stability of ceftriaxone formulations?
A2: Properly selected plastics such as polypropylene and polyethylene are chemically compatible, ensuring stability. Suppliers’ adherence to validated packaging processes is vital for maintaining drug efficacy.

Q3: Are there specific regional suppliers I should consider for procurement?
A3: Yes. Major regional players in India, China, and Turkey offer cost-effective, GMP-compliant ceftriaxone in plastic formats, suitable for local and international markets.

Q4: What are the advantages of pre-filled syringes versus vials for ceftriaxone?
A4: Pre-filled syringes reduce preparation time, minimize contamination risk, and improve patient safety through accurate dosing, making them preferable in hospital settings.

Q5: How can I ensure the supply chain reliability of ceftriaxone products?
A5: Choose suppliers with proven manufacturing capacity, robust logistics networks, contingency plans, and a history of on-time delivery to ensure continuity of supply.

Sources:
[1] WHO Prequalification of Medicines Program, Ceftriaxone in Injectable Form, 2022.
[2] PharmTech, “Top Ceftriaxone Suppliers and Manufacturers,” 2021.
[3] FDA Drug Database, Approved Ceftriaxone Products, 2023.
[4] European Medicines Agency, Marketing Authorizations for Ceftriaxone, 2022.
[5] MarketWatch, “Global Injectable Antibiotics Market Growth,” 2023.

Suppliers and packagers for CEFTRIAXONE IN PLASTIC CONTAINER