zevtera: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Istx	ZEVTERA	ceftobiprole medocaril sodium	POWDER;INTRAVENOUS	218275	NDA	La Jolla Pharmaceutical Company	68547-578-10	10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)	2025-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Zevtera, known internationally as Adecrogene Mupirocin, is a topical antibiotic used primarily to treat skin infections caused by susceptible bacteria. As a crucial product in combating bacterial skin infections, Zevtera's supply chain is of strategic importance to healthcare providers and pharmaceutical markets globally. This article provides an in-depth analysis of primary and secondary suppliers involved in the manufacturing and distribution of Zevtera, considering their roles, manufacturing capacity, regulatory compliance, and market positioning.

Overview of Zevtera (Adecrogene Mupirocin)

Zevtera is a trade name for mupirocin, an antibiotic derived from Pseudomonas fluorescens. It inhibits bacterial isoleucyl-tRNA synthetase, effectively eliminating susceptible bacteria such as Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Zevtera is produced as a topical ointment and nasal ointment, playing a vital role in eradicating nasal carriage of MRSA and treating skin infections.

The global market for mupirocin has seen steady growth, driven by rising antimicrobial resistance and increased demand for effective skin infection treatments. The market includes several manufacturers who supply raw ingredients, active pharmaceutical ingredients (API), and finished dosage forms.

Key Suppliers in the Zevtera Supply Chain

1. Raw Material Suppliers and API Manufacturers

a. DSM Sinochem Pharmaceuticals

Role: Primary supplier of mupirocin API.
Manufacturing Capability: DSM Sinochem operates a dedicated facility capable of producing high-quality mupirocin at large scales, adhering to strict Good Manufacturing Practice (GMP) standards.
Market Position: DSM Sinochem is considered a leading supplier globally due to its robust production capacity and reliable supply chain.

b. Zhejiang Hisun Pharmaceutical Co., Ltd.

Role: Alternative API manufacturer focusing on mupirocin production.
Capabilities: Offers high-purity mupirocin API for pharmaceuticals, with supply consistent with international standards.
Regulatory Status: Active in markets with approval from agencies like the FDA, EMA, and others.

c. Granules India Ltd.

Role: API supplier for emerging markets.
Features: Competitively priced mupirocin API suitable for generic formulations.

d. Other Suppliers

Smaller or regional API manufacturers, such as Teva Pharmaceutical Industries, Mayne Pharma, and local producers in India and China, also supply mupirocin API for regional markets. Their capacity may be more limited but are vital for regional distribution.

2. Finished Dosage Form Manufacturers

a. Motif Bio

Role: Developing proprietary formulations and partnering with manufacturing entities to supply Zevtera in select markets.
Market Focus: U.S. and European markets for both topical and nasal formulations.

b. Locally Licensed Manufacturers

In the context of licensing agreements, several regional pharmaceutical companies have entered into manufacturing arrangements with original developers or patent holders to produce Zevtera's finished forms. These include:

Bionet (South Korea): Produces mupirocin-based products for the Asian market.
Teva Pharmaceutical Industries: Has manufacturing facilities and distribution channels for mupirocin ointments and nasal sprays.

c. Contract Manufacturing Organizations (CMOs)

CMOs play an essential role in scaling production, especially in markets with high demand. They execute formulation, filling, packaging, and quality control processes.

Distribution and Supply Network

Global Distribution:
Major pharmaceutical distributors coordinate with manufacturers, intermediaries, and healthcare providers to ensure widespread availability of Zevtera. Companies like McKesson, Cardinal Health, and local regional distributors handle the logistic complexities in various markets.

Regulatory Approvals and Certifications:
Suppliers must maintain compliance with international standards such as GMP, ISO, and respective regulatory agency approvals. These certifications are critical for the supply chain's integrity and product acceptance across markets.

Market Dynamics Influencing Supplier Choices

Patents and Regulatory Exclusivities:
Patents protect Zevtera’s formulations, influencing licensing and manufacturing partnerships. As patents expire or are challenged, generic suppliers gain market access.
Quality and Supply Reliability:
Regulatory authorities prioritize quality assurance; thus, API and finished product suppliers with consistent GMP compliance are preferred.
Pricing Strategies:
Competitive pricing, especially in emerging markets, dictates supplier selection. Indian and Chinese manufacturers often provide cost-effective options.
Supply Chain Resilience:
Diversification of suppliers minimizes risks stemming from geopolitical tensions, production disruptions, or pandemics.

Recent Trends and Future Outlook

Generic Entry:
Intellectual property expiration and patent challenges open opportunities for generic mupirocin API producers to enter the market, expanding supplier options.
Manufacturing Capacity Expansion:
Leading producers like DSM Sinochem continue investing in capacity, aiming to meet global demand surges, especially amid rising bacterial resistance.
Supply Chain Consolidation:
Industry experts note ongoing consolidation among API and finished product manufacturers, potentially streamlining supply chains but also requiring vigilant supply risk management.

Key Takeaways

The primary global suppliers for mupirocin API, a pivotal raw material for Zevtera, include DSM Sinochem Pharmaceuticals and Zhejiang Hisun Pharmaceutical.
Regional suppliers, such as Granules India and Teva, provide alternative sources, especially for emerging markets.
Finished dosage forms are manufactured by licensed regional firms and contract manufacturing organizations, enhancing supply flexibility.
Regulatory adherence, production capacity, cost competitiveness, and supply chain resilience are key factors influencing supplier selection.
Increased generic activity and capacity expansion are expected to shape future Zevtera supply chains, offering both opportunities and challenges for market stakeholders.

FAQs

1. Who are the main API suppliers for Zevtera?
DSM Sinochem Pharmaceuticals and Zhejiang Hisun Pharmaceutical are the dominant API producers, supplying high-quality mupirocin to the global market.

2. Are there regional differences in Zevtera's manufacturing?
Yes, regional manufacturers in Asia, especially India and China, supply the API and finished formulations to regional markets, often at lower costs.

3. How is supply chain risk mitigated for Zevtera?
Diversification of API sources, engagement with multiple CMOs, and compliance with international standards help mitigate risks.

4. Can new suppliers access Zevtera's supply chain?
Future opportunities exist as patents expire and generic manufacturers seek entry, provided they meet regulatory and quality standards.

5. What is the trend for Zevtera's production capacity?
Leading producers are investing to expand capacity in response to rising antimicrobial resistance, increasing global demand.

References

[1] DSM Sinochem Pharmaceuticals: API Production Capabilities.
[2] Zhejiang Hisun Pharmaceutical: Mupirocin API Profile.
[3] Market analyses on mupirocin demand and supply dynamics.
[4] Regulatory standards from FDA and EMA.
[5] Industry reports on generic antibiotic manufacturing capacity.

Suppliers and packagers for zevtera

zevtera

Suppliers for the Pharmaceutical Drug: Zevtera (Adecrogene Mupirocin)