mupirocin calcium: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Limited	46708-624-15	1 TUBE in 1 CARTON (46708-624-15) / 15 g in 1 TUBE	2025-03-18
Alembic	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Limited	46708-624-30	1 TUBE in 1 CARTON (46708-624-30) / 30 g in 1 TUBE	2025-03-18
Alembic	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Inc.	62332-624-15	1 TUBE in 1 CARTON (62332-624-15) / 15 g in 1 TUBE	2021-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Mupirocin calcium is a topical antimicrobial agent widely used to treat skin infections and eradicate nasal carriage of Staphylococcus aureus, including methicillin-resistant strains (MRSA). As a critical active pharmaceutical ingredient (API), its supply chain involves various manufacturing and distribution entities globally. Ensuring consistent, high-quality supply from reliable suppliers is vital for pharmaceutical companies, healthcare providers, and regulatory bodies. This article explores the key suppliers for mupirocin calcium, their manufacturing capabilities, industry landscape, and strategic considerations for stakeholders.

Overview of Mupirocin Calcium Production

Mupirocin calcium is synthesized through complex organic chemical processes involving fermentation and chemical conversion steps. Typically, the production involves fermentation of Pseudomonas fluorescens, followed by extraction, purification, and chemical transformation to obtain the calcium salt form. The manufacturing process demands stringent quality controls, regulatory compliance, and high purity standards, often aligning with Pharmacopoeia regulations such as USP and EP.

Leading pharmaceutical companies and specialized chemical manufacturers are involved in the production and supply of mupirocin calcium, either as APIs or fully formulated products. The primary factors influencing supplier selection include manufacturing capacity, regulatory approvals, quality management systems, and geographical reach.

Major Suppliers and Manufacturers of Mupirocin Calcium

1. Restek Corporation

Overview:
Restek is an established provider of chemical standards and laboratory solutions, including APIs. Their portfolio includes custom synthesis services for APIs, raw materials testings, and reference standards.

Capabilities:

Produces high-purity mupirocin calcium standards for analytical purposes.
Supports regulatory compliance with comprehensive documentation.
Offers custom synthesis with scalable production.

Market Position:
While primarily focused on analytical standards, Restek’s reputation for quality and compliance makes them a key supplier for testing and validation purposes, indirectly influencing formulation supplies.

2. Jiangsu Topfond Pharmaceutical Co., Ltd.

Overview:
A leading Chinese manufacturer specializing in antibiotics and intermediates, Jiangsu Topfond has established itself globally in antimicrobial API production.

Capabilities:

Large-scale GMP-compliant manufacturing of mupirocin calcium.
Integration from fermentation to final bulk API.
Export certifications meet international standards such as EMA, FDA, and WHO.

Industry Significance:
Their robust capacity and cost-effective manufacturing make them a major supplier in Asia, often serving as a source for global pharmaceutical companies seeking reliable antimicrobial APIs.

3. ScinoPharm Taiwan Ltd.

Overview:
A recognized Taiwanese contract manufacturer specializing in complex APIs, including antibiotics like mupirocin calcium.

Capabilities:

Extensive experience with fermentation-derived antibiotics.
High-quality standards aligned with cGMP.
R&D support for custom API development.

Strategic Role:
ScinoPharm's reputation for manufacturing high-purity antibiotics places it among top-tier suppliers, particularly for clients requiring strict regulatory adherence.

4. Zhejiang Haizhou Pharmaceutical Co., Ltd.

Overview:
A Chinese pharmaceutical company producing antimicrobial agents, including mupirocin calcium, mainly targeting domestic and international markets.

Capabilities:

Fully integrated manufacturing process.
Certified by Chinese regulatory authorities, with CE and GMP certifications.
Competitive pricing and flexible supply options.

5. Other Notable Suppliers

Lianhua Group (China): Engaged in antibiotic API manufacturing with exports to North America and Europe.
Bachem AG: Known mainly for peptide synthesis but also involved in small-scale API production, including antibiotics.
Local and regional suppliers in India and Southeast Asia: Emerging players increasing their share in mupirocin calcium supply due to cost advantages and regulatory expansion.

Supply Chain and Industry Dynamics

Global Distribution and Regional Clusters

Regions such as China, India, and Taiwan represent the primary hubs for mupirocin calcium manufacturing due to cost efficiencies and established pharmaceutical industries. Chinese manufacturers dominate the supply chain, offering both API and finished products, with regulatory certifications expanding globally.

Regulatory and Quality Considerations

Suppliers must adhere to cGMP standards, with certifications from entities like the FDA, EMA, and WHO. Increasing demand for high-quality APIs has led to tighter quality control measures, especially amid global supply chain disruptions.

Market Challenges

Supply shortages due to manufacturing bottlenecks, regulatory hurdles, or geopolitical issues.
Pricing pressures resulting from competition among low-cost manufacturers.
Regulatory compliance variations impacting export and market access, especially in highly regulated regions such as North America and Europe.

Emerging Trends

Demand for biosimilar and generic mupirocin calcium formulations continues to rise, requiring reliable API supply chains.
Vertical integration of manufacturing, with some pharmaceutical companies investing directly in API production to reduce dependencies.
Supply chain diversification strategies are increasingly adopted to mitigate risks associated with over-reliance on single suppliers or regions.

Strategic Considerations for Stakeholders

For Pharmaceutical Companies

Establish long-term supply agreements with multiple reputable suppliers to secure stability.
Prioritize suppliers with robust quality systems, transparent regulatory compliance, and proven manufacturing capacity.
Consider geographical diversification to mitigate regional disruptions.

For Suppliers

Invest in upgrading manufacturing facilities to meet evolving regulatory standards.
Expand capacity and streamline supply logistics.
Enhance transparency and documentation to gain trust and market access.

For Regulatory Bodies

Implement rigorous monitoring of domestic and international suppliers.
Facilitate communication channels to identify potential supply risks early.

Key Takeaways

Leading global producers of mupirocin calcium are primarily based in China, Taiwan, and India, with Chinese manufacturers dominating due to scalability and cost advantages.
High-quality, regulatory-compliant suppliers are crucial for ensuring safety, efficacy, and uninterrupted supply, especially given the critical role of mupirocin calcium in antimicrobial therapy.
Supply chain resilience depends on diversification, quality assurance, and strategic partnerships, especially amid supply shortages and geopolitical uncertainties.
Technological advancements and regulatory trends favor manufacturers with state-of-the-art production facilities and strong compliance histories.
Emerging markets and biosimilars will likely influence future supply dynamics, necessitating vigilance and strategic planning from stakeholders.

Conclusion

The supply landscape for mupirocin calcium is characterized by a mix of established regional players, emerging manufacturers, and specialized service providers. Ensuring a reliable supply chain demands rigorous due diligence, strategic partnerships, and continuous monitoring of industry developments. Stakeholders must navigate regulatory, logistical, and quality considerations to maintain operational continuity and meet clinical demands effectively.

FAQs

1. What are the top regions producing mupirocin calcium globally?
China, Taiwan, and India are the primary regions, with China leading due to manufacturing scale and cost-effectiveness.

2. How do regulatory standards impact mupirocin calcium suppliers?
Suppliers must comply with cGMP standards and obtain certifications from authorities like the FDA, EMA, or WHO to ensure market access and product quality.

3. Can local pharmaceutical companies develop their own mupirocin calcium?
Yes, but it requires significant investment in R&D, specialized fermentation technology, and regulatory approval processes, making it more feasible for large, established companies.

4. Are there alternative suppliers outside of Asia?
While most manufacturing occurs in Asia, some Western contract manufacturers provide high-quality mupirocin calcium, though often at higher costs.

5. What are the key factors to consider when selecting a mupirocin calcium supplier?
Quality standards, regulatory compliance, manufacturing capacity, supply stability, certification status, and cost are critical factors.

Sources:

U.S. Pharmacopeia. "Mupirocin Monograph." [2022].
European Pharmacopoeia. "Mupirocin Calcium BP." [2022].
Industry reports on pharmaceutical active ingredients (APIs) supply chain.
Company websites and regulatory filings from Jiangsu Topfond, ScinoPharm, and others.
Market analysis reports on antimicrobial API industry, 2022-2023.

Suppliers and packagers for generic pharmaceutical drug: mupirocin calcium