Suppliers and packagers for teflaro

teflaro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0400-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)	2010-10-29
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0600-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)	2010-10-29

Suppliers for the Pharmaceutical Drug: TEFLARO

Last updated: July 29, 2025

Introduction

TEFLARO (ceftaroline fosamil) is a broad-spectrum, injectable cephalosporin antibiotic indicated primarily for the treatment of complicated skin and soft tissue infections (cSSTIs) and community-acquired pneumonia (CAP). Since its approval by the U.S. Food and Drug Administration (FDA) in 2010, TEFLARO has become a significant therapeutic option in hospitals and healthcare settings worldwide. Its manufacturing and supply chain involve multiple stakeholders, including raw material suppliers, contract manufacturing organizations (CMOs), and distribution companies. This article explores the key suppliers contributing to TEFLARO’s production, highlighting their roles, global footprints, and strategic importance.

Manufacturing and Supply Chain Overview

TEFLARO’s production hinges on the synthesis of ceftaroline fosamil, a prodrug that is converted in vivo to the active ceftaroline. The supply chain encompasses several critical stages:

• Raw material procurement: including the synthesis of complex intermediates.
• Active Pharmaceutical Ingredient (API) production: bulk manufacture of ceftaroline fosamil.
• Formulation and fill-finish: turning APIs into injectable formulations.
• Distribution: ensuring timely delivery to healthcare facilities globally.

Given the complexity and regulatory requirements, pharmaceutical companies often rely on a network of specialized suppliers across different countries.

Key Raw Material Suppliers

The production of ceftaroline fosamil depends on high-purity chemical intermediates sourced from specialized raw material suppliers. These suppliers must adhere to stringent quality standards, including Good Manufacturing Practices (GMP).

1. Harbin Pharmaceutical Group (Hayao Pharmaceutical)
   Based in China, Hayao supplies key intermediates used in ceftaroline synthesis. Their technical expertise in complex chemical synthesis makes them a strategic partner for raw material procurement.

2. Jiangsu Hualan Biological Engineering Inc.
   Also based in China, Hualan provides specialized chemical intermediates and supports APIs’ synthesis with a focus on purity and consistency.

3. Lonza Group (Switzerland)
   A global leader in custom chemical manufacturing, Lonza produces active intermediates and APIs for numerous antibacterials, including ceftaroline. Their facilities comply with international GMP standards, making them a preferred supplier among top pharmaceutical companies.

API Manufacturing Partners

The production of the active pharmaceutical ingredient (API) — ceftaroline fosamil — is a highly regulated process involving multiple CMOs. Major API manufacturers for TEFLARO include:

1. Hangzhou Techmed Pharmaceuticals Co., Ltd.
   A pivotal Chinese manufacturer with proven capability in cephalosporin APIs, Techmed supplies bulk API to several pharmaceutical firms, including those producing TEFLARO. Their capacity expansion and quality systems enable large-scale GMP production.

2. Sino Pharmacept
   Based in China, Sino Pharmacept specializes in beta-lactam antibiotics' synthesis, including ceftaroline. Their facilities meet international quality standards, enabling export to global markets.

3. CordenPharma
   Located in Austria and the U.S., CordenPharma provides contract manufacturing services for complex APIs, including ceftaroline fosamil. Their advanced manufacturing suites ensure high purity and batch consistency, critical for injectable products.

Formulation and Fill-Finish Suppliers

The final stage involves converting the API into an injectable form, requiring sterile processing, formulation, and packaging. Several CMOs specialize in aseptic fill-finish for antibiotics like TEFLARO:

1. Baxter International (United States)
   Baxter operates sterile manufacturing facilities capable of large-scale fill-finish of injectable antibiotics. Their expertise guarantees compliance with regulatory standards and reliable supply.

2. Recipharm (Sweden)
   Recipharm provides aseptic filling and packaging services for many injectable pharmaceuticals, maintaining quality assurance for TEFLARO’s final formulation.

3. Famar
   With facilities across Europe, Famar specializes in sterile filling and finishing of injectables, offering flexible capacity for market demands.

Distribution and Logistics Partners

Timely and compliant distribution is critical for antibiotics manufactured for hospital use. Major logistics players include:

• McKesson Logistics: For North American distribution.
• UPS Healthcare: Providing global cold chain logistics.
• DHL Healthcare: Ensures temperature-controlled transportation for TEFLARO across Europe and Asia.

Strategic Considerations

The global supply chain for TEFLARO features reliance on China and Europe for raw materials and APIs. Supply chain disruptions—such as geopolitical tensions, manufacturing bottlenecks, or regulatory delays—pose risks to consistent availability. Consequently, pharmaceutical companies often seek diversified supplier bases and strategic stockpiles.

Regulatory and Quality Assurance Aspects

Suppliers must comply with GMP, ICH guidelines, and regional regulatory requirements. Companies like Lonza and CordenPharma hold cGMP certifications across multiple jurisdictions, easing global distribution. Transparency reports and supplier audits are standard to maintain high-quality standards.

Emerging Trends and Market Dynamics

As demand for broad-spectrum antibiotics grows, especially in the face of rising antibiotic resistance, supply chains for TEFLARO are under increased scrutiny. Initiatives include:

• Supply chain diversification to reduce dependence on single-source suppliers.
• Vertical integration, with some pharmaceutical companies investing in their own API manufacturing.
• Innovation in manufacturing processes, such as continuous flow synthesis, to enhance capacity and reduce costs.

Conclusion

The supply chain for TEFLARO demonstrates a complex network of specialized suppliers across regions. China remains a dominant source of raw materials and APIs, complemented by European experts in formulation and fill-finish. Maintaining this elaborate ecosystem while navigating geopolitical, regulatory, and logistical challenges remains vital for ensuring uninterrupted access to this critical antibiotic.

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Key Takeaways

• Global supplier diversity is essential to mitigate risks associated with geopolitical and logistical disruptions.
• High standards of GMP compliance from suppliers like Lonza and CordenPharma underpin TEFLARO’s quality and safety.
• Vertical integration and strategic partnerships are increasingly explored to ensure supply continuity.
• Regulatory adherence across all tiers of the supply chain influences global availability.
• Innovation and diversification in manufacturing processes are crucial for meeting future demand and combating antimicrobial resistance.

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5 FAQs

1. Who are the primary raw material suppliers for TEFLARO?
Chinese companies like Harbin Pharmaceutical Group and Jiangsu Hualan Biological Engineering are key suppliers of intermediates. Swiss-based Lonza also supplies high-quality chemical intermediates used in API synthesis.

2. Which companies manufacture the API for TEFLARO?
Major API manufacturers include Hangzhou Techmed Pharmaceuticals and CordenPharma, both with proven GMP capabilities in ceftaroline fosamil production.

3. Are there any alternative suppliers if current ones face disruption?
Yes, pharmaceutical companies are building diversified supplier networks, importing from multiple regions, and investing in in-house manufacturing to ensure supply resilience.

4. What role do formulation and fill-finish suppliers play?
They transform bulk API into sterile, injectable formulations. Companies like Baxter, Recipharm, and Famar provide these essential services, ensuring TEFLARO reaches hospitals safely and effectively.

5. How does geopolitical tension impact TEFLARO’s supply chain?
Dependence on Chinese and European suppliers exposes the supply chain to risks like trade restrictions, export controls, and manufacturing bottlenecks, emphasizing the need for diversification and strategic planning.

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References

1. U.S. Food and Drug Administration. (2010). TEFLARO (ceftaroline fosamil) Approval Announcement.
2. Market reports on global antibiotic manufacturing. (2022).
3. Lonza Group official website. (2023). Supply Chain and Manufacturing Capabilities.
4. CordenPharma. (2023). API Manufacturing Services for Antibiotics.
5. Industry analyses on pharmaceutical supply chain resilience. (2023).