Suppliers and packagers for generic pharmaceutical drug: mupirocin calcium

mupirocin calcium

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

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
Alembic	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Inc.	62332-624-30	1 TUBE in 1 CARTON (62332-624-30) / 30 g in 1 TUBE	2021-12-01

Mupirocin Calcium Suppliers: Global Market Analysis and Key Players

Last updated: February 19, 2026

This report analyzes the global supply landscape for mupirocin calcium, a topical antibiotic. The market is characterized by a limited number of active pharmaceutical ingredient (API) manufacturers. Key considerations for pharmaceutical companies include API purity, regulatory compliance, and supply chain resilience.

What is Mupirocin Calcium?

Mupirocin calcium is the calcium salt of mupirocin, a naturally occurring antibiotic produced by Pseudomonas fluorescens. It exhibits broad-spectrum activity against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and to a lesser extent, against certain Gram-negative bacteria. Its mechanism of action involves inhibiting bacterial isoleucyl-tRNA synthetase, an enzyme essential for protein synthesis [1].

Mupirocin calcium is primarily used topically for the treatment of bacterial skin infections, such as impetigo, folliculitis, and furunculosis. It is also used for the eradication of nasal carriage of Staphylococcus aureus in certain clinical settings. The drug's efficacy and favorable safety profile have maintained its relevance in clinical practice.

Global Mupirocin Calcium API Manufacturing Landscape

The production of mupirocin calcium API is concentrated among a select group of manufacturers, primarily located in Asia. This concentration presents both opportunities and challenges for downstream formulators and pharmaceutical companies.

Key API Manufacturers

The following companies are identified as significant manufacturers or suppliers of mupirocin calcium API. Information regarding production capacity and market share is proprietary and not publicly disclosed by most entities.

• Changzhou K.A. Chemical Co., Ltd. (China): This company is a known supplier of pharmaceutical intermediates and APIs. Publicly available information indicates their involvement in the production of mupirocin calcium. They are registered with various regulatory bodies, suggesting adherence to international quality standards.
• Neuland Laboratories Limited (India): Neuland is an established API manufacturer with a broad portfolio. They produce APIs for various therapeutic areas and are known for their regulatory expertise, including US FDA and EDQM certifications. Their product catalog lists mupirocin calcium as an offering.
• Abbott India Limited (India): While Abbott is primarily known as a finished dosage form manufacturer, their Indian subsidiary has historically been involved in API production. Their involvement in mupirocin calcium supply is notable, though the extent of their current API manufacturing is not consistently detailed in public disclosures.
• Nantong Ascend Pharmaceutical Co., Ltd. (China): This company specializes in the development and manufacturing of APIs. Their product list includes mupirocin calcium, and they emphasize quality control and regulatory compliance in their operations.
• API Group (India): This group is an umbrella term for several Indian API manufacturers that may produce mupirocin calcium. Specific company names within this group are difficult to isolate without direct engagement, but India remains a significant source of generic APIs.
• Specific Chinese Manufacturers: Beyond Changzhou K.A. Chemical and Nantong Ascend, numerous smaller to mid-sized chemical and pharmaceutical companies in China are involved in the production of mupirocin and its derivatives. These entities often operate under less stringent public reporting requirements, making definitive identification challenging.

Geographic Concentration

The majority of mupirocin calcium API production is located in China and India. These regions benefit from established chemical manufacturing infrastructure, skilled labor, and competitive manufacturing costs.

• China: Home to a significant number of API manufacturers, offering a broad range of chemical synthesis capabilities.
• India: A leading global supplier of generic APIs, with a strong emphasis on regulatory compliance and exports to regulated markets.

Factors Influencing Mupirocin Calcium Supply

Several factors impact the availability, quality, and cost of mupirocin calcium API.

Regulatory Compliance

API manufacturers must adhere to strict regulatory standards to supply markets in the United States, Europe, and other regulated regions. Key compliance requirements include:

• Good Manufacturing Practices (GMP): Certification from regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) is crucial for market access [2].
• Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory authorities, providing detailed information about the API's manufacturing process, quality control, and stability. This allows formulators to reference the DMF in their drug product applications.
• Impurity Profiling: Rigorous control and characterization of impurities are essential to meet pharmacopoeial standards (e.g., USP, EP) and regulatory requirements.

Quality and Purity Specifications

Mupirocin calcium API must meet specific quality and purity benchmarks to ensure the safety and efficacy of the final drug product.

• Assay: Typically, the mupirocin calcium content is specified within a narrow range, often 98.0% to 102.0% on an anhydrous basis.
• Related Substances: Limits are set for specific process-related impurities and degradation products. These limits are defined by pharmacopoeias and are critical for regulatory approval. For example, USP monograph for Mupirocin Calcium outlines specific impurity limits [3].
• Residual Solvents: Limits for residual solvents used during synthesis must comply with ICH Q3C guidelines.

Supply Chain Dynamics

The concentration of API manufacturing in a few regions creates potential vulnerabilities.

• Geopolitical Risks: Trade disputes, environmental regulations, and political instability in manufacturing regions can disrupt supply chains.
• Lead Times: Securing a reliable supply requires engagement with manufacturers well in advance due to production cycles and shipping times.
• Dual Sourcing: Pharmaceutical companies often seek to qualify multiple API suppliers to mitigate risk, but the limited number of qualified mupirocin calcium manufacturers can make this challenging.

Cost Considerations

Manufacturing costs are influenced by raw material availability, labor costs, regulatory compliance expenses, and economies of scale.

• Raw Materials: The availability and cost of key starting materials for mupirocin synthesis can impact API pricing.
• Energy and Environmental Compliance: Increasing environmental regulations in major manufacturing hubs can add to production costs.

Opportunities and Challenges for Pharmaceutical Companies

Pharmaceutical companies seeking to develop or manufacture mupirocin calcium-based products face specific opportunities and challenges.

Opportunities

• Established Market: Mupirocin calcium is a well-established antibiotic with a recognized clinical role, ensuring ongoing demand.
• Generic Competition: The patent expiries for mupirocin calcium products allow for generic competition, creating opportunities for formulators.
• Contract Manufacturing: For companies without in-house API manufacturing capabilities, partnering with qualified contract manufacturing organizations (CMOs) or directly with API suppliers is standard practice.

Challenges

• API Sourcing: Identifying and qualifying reliable, high-quality API suppliers is a primary challenge due to the limited number of manufacturers.
• Regulatory Hurdles: Navigating the complex regulatory landscape for API approval, especially in new markets, requires significant expertise and investment.
• Intellectual Property: While the primary patents for mupirocin calcium may have expired, second-generation patents related to novel formulations or delivery systems could still be active, requiring careful IP due diligence.
• Price Volatility: Supply chain disruptions or increased raw material costs can lead to price fluctuations in the API market.

Key Takeaways

• The global supply of mupirocin calcium API is concentrated among a limited number of manufacturers, predominantly in China and India.
• Regulatory compliance (GMP, DMFs) and stringent quality control are paramount for API suppliers to serve regulated markets.
• Pharmaceutical companies must establish robust supply chain management strategies, including potential dual sourcing where feasible, to ensure consistent access to mupirocin calcium API.
• Understanding API impurity profiles and meeting pharmacopoeial standards are critical for product development and regulatory approval.
• The competitive landscape for generic mupirocin calcium products presents opportunities, but these are contingent on securing reliable API sources.

Frequently Asked Questions

1. Who are the primary API manufacturers for mupirocin calcium?

The primary API manufacturers for mupirocin calcium are concentrated in China and India. Key entities include Changzhou K.A. Chemical Co., Ltd., Neuland Laboratories Limited, Nantong Ascend Pharmaceutical Co., Ltd., and potentially other manufacturers within groups like API Group.

2. What are the main regulatory requirements for mupirocin calcium API suppliers?

Key regulatory requirements include adherence to Good Manufacturing Practices (GMP) as certified by bodies such as the U.S. FDA and EDQM, and the filing of Drug Master Files (DMFs) with relevant health authorities.

3. How can pharmaceutical companies ensure supply chain resilience for mupirocin calcium API?

Supply chain resilience can be enhanced through qualifying multiple API suppliers, maintaining adequate inventory levels, and conducting regular audits of manufacturing sites to ensure ongoing compliance and operational stability.

4. What are the typical quality specifications for mupirocin calcium API?

Typical quality specifications include assay within the range of 98.0% to 102.0% on an anhydrous basis, strict limits for related substances as defined by pharmacopoeias like USP and EP, and compliance with residual solvent limits according to ICH Q3C guidelines.

5. Are there significant intellectual property concerns related to mupirocin calcium API?

While the primary patents for mupirocin calcium as a molecule have expired, companies must conduct thorough due diligence regarding any potential secondary patents covering novel manufacturing processes, formulations, or specific polymorphs that might impact their ability to market mupirocin calcium-based products.

Citations

[1] Allen, D. F., & J. P. M. van der Merwe. (1991). Mupirocin: A novel topical antimicrobial agent. Clinical Pharmacy, 10(7), 496-502.

[2] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practices (GMP). Retrieved from [FDA GMP website] (Note: Specific URL not provided as it changes, but "FDA GMP" is a standard search term).

[3] United States Pharmacopeia. (2023). USP Monograph Mupirocin Calcium. In United States Pharmacopeia and National Formulary (USP 46-NF 41).