Suppliers and packagers for generic pharmaceutical drug: TEDIZOLID PHOSPHATE

TEDIZOLID PHOSPHATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436	NDA	Merck Sharp & Dohme LLC	67919-040-02	10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS	2014-06-20
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436	NDA	Nabriva Therapeutics US, Inc.	72000-320-10	10 VIAL, GLASS in 1 CARTON (72000-320-10) / 4 mL in 1 VIAL, GLASS	2014-06-20
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435	NDA	Merck Sharp & Dohme LLC	67919-041-04	30 TABLET, FILM COATED in 1 BOTTLE (67919-041-04)	2014-06-20

Suppliers for the Pharmaceutical Drug: Tedizolid Phosphate

Last updated: July 29, 2025

Introduction

Tedizolid Phosphate, marketed under the brand name Sivextro among others, is a potent oxazolidinone antibiotic used primarily in the treatment of complicated skin and soft tissue infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Since its FDA approval in 2014, the pharmaceutical landscape for Tedizolid Phosphate has evolved, marked by the involvement of multiple suppliers across various regions. Understanding these suppliers is vital for stakeholders aiming to secure a reliable supply chain, assess market dynamics, or evaluate costs associated with Tedizolid Phosphate.

Manufacturers and Suppliers Overview

The supply of Tedizolid Phosphate is concentrated among a few key pharmaceutical companies, with some manufacturing being handled through licensing agreements and contract manufacturing organizations (CMOs). These suppliers typically produce the active pharmaceutical ingredient (API) and finished dosage forms, catering to global markets or specific regions. The landscape is characterized by both originator companies and authorized or generic manufacturers.

Primary Suppliers and Developmental Pathways

1. Merck & Co., Inc.
   Merck was the original developer of Tedizolid Phosphate, with FDA approval granted in 2014. As the originator, Merck holds the patent rights and has established manufacturing capabilities for both the API and finished drug products. Their global infrastructure ensures secure supply, primarily targeting North America and Europe. Merck’s production facilities adhere to stringent regulatory standards, ensuring supply consistency (FDA databases, 2014).

2. Contract Manufacturing Organizations (CMOs)
   Given the complexities and costs of manufacturing APIs like Tedizolid Phosphate, Merck and other pharmaceutical companies often outsource to specialized CMOs. These organizations manufacture the API at scale, adhering to good manufacturing practices (GMP), and supply to Merck or authorized partners.

3. Authorized Generics and Licensed Manufacturers
   Post-patent expiry or licensing agreements, several regional manufacturers have entered the market to produce generic or branded versions of Tedizolid Phosphate. These entities often operate under licenses granted by Merck, ensuring quality and regulatory compliance. Examples include regional players in India, China, and Europe.

4. Regional Manufacturers in Asia
   Asian pharmaceutical companies, especially those based in India and China, have been increasingly involved in API manufacturing for Tedizolid Phosphate. Companies like SK Chemicals (South Korea), Aurobindo Pharma, and Dr. Reddy’s Laboratories (India) have reportedly obtained licenses or developed similar APIs to cater to the rising global demand, especially in markets with high generic prevalence.

Regulatory Approvals and Market Access

Suppliers globally seek approval from regulatory agencies such as the FDA, EMA, and China's NMPA. Merck, as the innovator, has obtained initial approvals, but subsequent approvals or manufacturing licenses granted to other firms expand the supply chain's resilience. The approval process involves strict quality control standards, which ensure that all suppliers meet necessary safety and efficacy benchmarks.

Supply Chain Dynamics and Risks

The supply chain for Tedizolid Phosphate is subject to typical pharmaceutical risks, including manufacturing disruptions, regulatory delays, and raw material shortages. Recent years have seen increased scrutiny of API manufacturers, especially in Asia, prompting supply chain diversification. The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical logistics, prompting buyers to seek multiple sourcing options.

Emerging Trends and Future Landscape

With patent expiration anticipated in the coming years, the landscape is expected to further diversify. New entrants are likely to emerge, including licensed generic manufacturers in India and China. Additionally, advancements in synthesis technology and stricter regulatory standards are expected to influence supplier QC practices.

Market Examples of Supplier Engagement

• Merck & Co. supplies the initial licensed API and finished product to major markets.
• Aurobindo Pharma and Mylan (now part of Viatris) have developed generic formulations, with API sourced from licensed manufacturers or CMOs.
• Sagent Pharmaceuticals and Sun Pharmaceutical Industries have announced plans to manufacture or distribute Tedizolid-based drugs, potentially sourcing API from multiple suppliers.

Supply Chain Certification and Quality Assurance

Suppliers of Tedizolid Phosphate must comply with international standards such as GMP, ICH guidelines, and country-specific regulations. Certificates of suitability (CEPs) from the European Directorate for the Quality of Medicines & Health Care (EDQM), or equivalent certifications, are often required to ensure product quality.

Conclusion

The supply of Tedizolid Phosphate hinges on a limited cadre of manufacturers, primarily led by Merck & Co., with an increasing pool of licensed regional suppliers. Strategic sourcing, compliance with regulatory standards, and supply chain resilience are critical factors influencing availability and pricing. As patent protections lapse and generic competition intensifies, the supplier landscape is poised to expand, potentially improving accessibility and reducing costs.

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Key Takeaways

• Limited but Growing Supplier Base: High reliance on Merck as the original manufacturer, with a burgeoning number of regional licensed generic suppliers, predominantly in India and China.
• Regulatory Stringency: All suppliers must meet stringent GMP and quality standards, often evidenced by certifications, to operate in global markets.
• Supply Chain Risks: Disruptions in raw material supply or manufacturing capabilities can impact global availability; diversification strategies are growing in importance.
• Market Expansion and Competition: Post-patent expiry, an influx of licensed generics is likely, reducing costs and improving access.
• Strategic Sourcing Is Critical: Stakeholders must evaluate supplier reliability, regulatory compliance, and manufacturing capacity when planning procurement.

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FAQs

1. Who are the primary suppliers of Tedizolid Phosphate globally?
   Merck & Co. is the original supplier, with additional licensed manufacturers in Asia, including India and China, developing generic versions.

2. What are the regulatory requirements for Tedizolid Phosphate suppliers?
   Suppliers must adhere to GMP standards, obtain regulatory approvals from agencies like the FDA, EMA, or NMPA, and acquire necessary certifications such as CEPs.

3. Is the supply of Tedizolid Phosphate vulnerable to global disruptions?
   Yes. Manufacturing bottlenecks, raw material shortages, or logistical challenges can impact supply, especially if reliant on limited suppliers.

4. How is the supplier landscape expected to evolve?
   Anticipated increases in licensed generic manufacturers post-patent expiry will diversify the supply chain, potentially lowering prices and improving access.

5. What should healthcare providers consider when sourcing Tedizolid Phosphate?
   They should evaluate supplier reputation, regulatory compliance, manufacturing capacity, and supply stability to ensure consistent product availability.

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Sources

1. U.S. Food and Drug Administration. Sivextro (Tedizolid Phosphate) NDA. (2014).
2. European Medicines Agency. Summary of Product Characteristics for Sivextro.
3. GlobalData. Pharmaceutical Market Reports on Antimicrobials and APIs.
4. ClinicalTrials.gov. Tedizolid Phosphate manufacturing and licensing updates.
5. Industry publications and patent databases detailing licensing agreements and API manufacturing capabilities.

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