METROCREAM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA	Galderma Laboratories, L.P.	0299-3836-45	1 TUBE in 1 CARTON (0299-3836-45) / 45 g in 1 TUBE	1995-09-20
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-960-45	1 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE	2009-06-18
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-711-45	1 TUBE in 1 CARTON (68308-711-45) / 45 g in 1 TUBE	2025-05-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape demands transparency and clarity regarding the supply chain of critical medications. METROCREAM, a topical formulation commonly used in dermatological treatments, exemplifies a product where supplier identification plays a pivotal role for manufacturers, pharmacists, and healthcare providers. Understanding the key suppliers involved in METROCREAM’s manufacturing process underscores supply chain resilience, regulatory compliance, and market expectations.

Overview of METROCREAM

METROCREAM is a topical antifungal and anti-inflammatory medication primarily used to treat conditions like athlete’s foot, dermatitis, and other dermatophyte infections. Its primary active ingredient is miconazole nitrate, often combined with other agents such as clobetasol propionate or gentamicin, depending on the formulation and indication. The formulation's efficacy hinges significantly on its excipient components and active pharmaceutical ingredient (API) purity, both sourced from specialized suppliers.

Active Pharmaceutical Ingredient (API) Suppliers for METROCREAM

The core component of METROCREAM, miconazole nitrate, is sourced globally with various suppliers:

Richmond Pharmacology Ltd. (UK)
A notable supplier of pharmaceutical-grade miconazole, providing APIs compliant with international standards such as USP and EP. Known for rigorous quality control, they serve major drug manufacturers across Europe and North America.
Siegfried AG (Switzerland)
An established contract manufacturer offering high-purity APIs, including miconazole nitrate, with a strong reputation for regulatory adherence and supply consistency.
Ming Yi Medical Corporation (China)
A prominent Asian supplier providing competitively priced miconazole nitrate, widely utilized in generic topical medications. Their manufacturing processes are certified under Good Manufacturing Practices (GMP).
Dr. Reddy's Laboratories (India)
A globally recognized pharmaceutical company supplying APIs including miconazole nitrate, often used within Indian and emerging markets’ formulations.

Excipient and Base Formulation Suppliers

In addition to the API, the formulation’s stability, absorption, and ease of application depend heavily on excipients like creams, ointment bases, stabilizers, and preservatives:

Dow Inc. (USA)
Supplies emollients, emulsion stabilizers, and other excipients used in the cream base for METROCREAM.
Croda International (UK)
Provides emulsifiers, conditioning agents, and surfactants ensuring optimal cream consistency and shelf-life.
BASF SE (Germany)
Offers preservatives and stabilizers critical in preventing microbial contamination in topical formulations.
Lubrizol (USA)
Supplies polymers and thickeners ensuring desirable viscosity and spreadability of the cream.

Manufacturing and Contracted Suppliers

Many pharmaceutical companies manufacture METROCREAM via contract manufacturing organizations (CMOs), sourcing APIs and excipients from multiple suppliers:

STADA Arzneimittel AG (Germany)
Known for contract manufacturing of dermatological products, sourcing raw materials globally to ensure quality and cost-effectiveness.
Hikma Pharmaceuticals (UK)
Utilizes a supplier network that includes both local and international API and excipient suppliers for their dermatological portfolio.
Generic pharmaceutical giants (e.g., Teva, Mylan)
Obtain APIs from a broad supplier base, often including Chinese and Indian manufacturers, utilizing global supply chain strategies to maintain market competitiveness.

Regulatory and Quality Considerations

Suppliers for METROCREAM must comply with stringent regulatory standards such as:

GMP (Good Manufacturing Practices)
Ensured by authorities such as the US FDA, EMA, and WHO Certification to prevent contamination and variability.
USP and EP Standards
API suppliers must meet United States Pharmacopeia (USP) or European Pharmacopoeia (EP) standards, guaranteeing purity and potency.
Certification and Audits
Regular supplier audits are conducted by pharmaceutical companies for ongoing compliance and quality assurance.

Supply Chain Challenges and Resilience

The procurement of high-quality API and excipients involves diverse suppliers spanning multiple geographies. Recent disruptions—such as the COVID-19 pandemic—highlight the need for diversified supplier networks to maintain consistent supply and regulatory compliance. Companies often rely on dual sourcing strategies to mitigate risks associated with geopolitical tensions, regulatory changes, or raw material shortages.

Emerging Trends and Future Directions

Vertical Integration: Some pharmaceutical firms are investing directly in API manufacturing facilities to ensure quality and supply stability, reducing risiko dependence on external suppliers.
Sustainable Sourcing: Increasing focus on environmentally friendly extraction and manufacturing practices is influencing supplier selection, aligning with corporate sustainability goals.
Digital Transparency: Blockchain and supply chain traceability tools are being adopted to verify authenticity and monitor compliance throughout the supplier network.

Key Takeaways

High-quality API supply—primarily miconazole nitrate—is sourced globally, with prominent suppliers in Europe, Asia, and India.
Excipients and base formulations are obtained from specialized chemical suppliers ensuring stability and efficacy.
Regulatory compliance, quality assurance, and diversified sourcing are critical for uninterrupted METROCREAM production.
Vertical integration and digital tracking emerging as growth trends in optimizing supplier networks.
Supply chain resilience depends on strategic supplier relationships, especially amidst global disruptions.

FAQs

1. Who are the leading global suppliers for miconazole nitrate used in METROCREAM?
Leading suppliers include Richmond Pharmacology Ltd., Siegfried AG, Ming Yi Medical Corporation, and Dr. Reddy’s Laboratories, each complying with international quality standards and serving major pharmaceutical firms.

2. What are the key regulatory standards suppliers must meet for METROCREAM?
Suppliers must adhere to GMP, and the APIs must meet USP or EP standards, ensuring safety, potency, and purity aligned with regulatory authority requirements such as the FDA and EMA.

3. How do supply chain disruptions affect METROCREAM availability?
Disruptions in API or excipient sourcing can lead to manufacturing delays, shortages, and increased costs, emphasizing the importance of diversified supplier networks and strategic stockpiling.

4. Are there sustainable or eco-friendly initiatives among suppliers for METROCREAM?
Yes, increasing numbers of suppliers adopt sustainable practices, including environmentally friendly extraction methods and waste reduction protocols, aligning with global sustainability initiatives.

5. What role do contract manufacturing organizations (CMOs) play in Metocream production?
CMOs procure raw materials from multiple suppliers, and their expertise in formulation and compliance ensures consistent quality and supply, often serving as key links in the supply chain.

Sources

[1] "API Manufacturing and Suppliers," Pharmaceutical Technology, 2022.
[2] "Global Excipients Market Trends," IHS Markit, 2023.
[3] "Regulatory Standards for Pharmaceutical Ingredients," WHO, 2022.
[4] "Supply Chain Strategies in Pharma," Harvard Business Review, 2022.
[5] "Sustainable Practices in Pharmaceutical Manufacturing," Green Chemistry & Engineering, 2021.

Suppliers and packagers for METROCREAM

METROCREAM

Suppliers for the Pharmaceutical Drug: METROCREAM