Suppliers and packagers for METROLOTION

METROLOTION

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	METROLOTION	metronidazole	LOTION;TOPICAL	020901	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-961-59	1 BOTTLE in 1 CARTON (66993-961-59) / 59.7 g in 1 BOTTLE	2009-05-28
Galderma Labs Lp	METROLOTION	metronidazole	LOTION;TOPICAL	020901	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-712-59	1 BOTTLE in 1 CARTON (68308-712-59) / 59.7 g in 1 BOTTLE	2025-02-10

Suppliers for the Pharmaceutical Drug: Metrolotion

Last updated: August 1, 2025

Introduction

Metrolotion, a topical formulation combining metronidazole and other active agents, is primarily used to treat skin conditions such as rosacea, erythrasma, and certain bacterial infections. As a specialized pharmaceutical product, its supply chain involves a network of raw material providers, formulation manufacturers, and distribution companies. Ensuring a reliable supplier network is critical for pharmaceutical companies seeking to maintain product quality, regulatory compliance, and market competitiveness. This article provides an in-depth overview of suppliers involved in the manufacturing and distribution of Metrolotion, analyzing key players, raw materials, manufacturing options, and market trends.

Understanding Metrolotion Composition and Manufacturing Needs

Metrolotion typically contains:

• Active Ingredient: Metronidazole (antimicrobial and anti-inflammatory agent)
• Carrier Base: Topical excipients such as emulsifiers, stabilizers, preservatives, and viscosity agents
• Additional Active Agents: Sometimes combined with other therapeutics depending on formulation specifics

The manufacturing process requires high-quality raw materials conforming to pharmacopeial standards (e.g., USP, EP), sterile processing capabilities, and quality assurance systems.

Key Raw Material Suppliers

Metronidazole Raw Material Suppliers

As the core active ingredient, metronidazole raw material suppliers are critical. The global market features several prominent producers:

• Sachez Chemicals: A prominent producer of pharmaceutical-grade metronidazole intermediates and active pharmaceutical ingredients (APIs). They supply to major pharmaceutical companies in North America and Europe. Their facilities adhere to Good Manufacturing Practices (GMP), ensuring regulatory compliance.

• Han Hung Pharmaceutical: Based in China, they are among the leading API producers of metronidazole, offering competitive pricing and reliable supply chains suited for generic formulations.

• Hubei Enyu Pharmaceutical Co., Ltd.: A Chinese API producer specializing in antiprotozoal and antimicrobial APIs, including metronidazole, with validated GMP facilities.

• Prasco Laboratories: A US-based supplier providing regulatory-approved APIs, including metronidazole, for pharmaceutical manufacturers emphasizing quality and compliance standards.

Excipients and Formulation Ingredients Suppliers

Precision in topical formulation relies on high-grade excipients:

• FMC Corporation: Supplies emulsifiers and stabilizers such as cetostearyl alcohol, glycerol, and other emollients.

• Dow Corning: Provides silicone-based excipients, enhancing the stability and skin absorption characteristics of Metrolotion.

• Ashland Global Holdings: Offers preservatives and viscosity-enhancing agents compatible with topical formulations.

Formulation and Manufacturing Partners

Manufacturing Metrolotion involves specialized companies with expertise in topical drug products:

• Perrigo Company: A leading contract manufacturer with extensive experience in topical formulations, including metronidazole-based creams and lotions.

• Recipharm: Offers GMP-certified facilities capable of large-scale topical manufacturing, compliance with regulatory standards, and flexible formulation development.

• Makers of Private Label Cosmetics and Pharmaceuticals: Such as Alpheus Pharmaceuticals and Strides Pharma, which can adapt formulations to customer specifications with robust quality management systems.

Regulatory and Quality Considerations

Suppliers must meet stringent regulatory standards:

• GMP Certification: Ensures raw materials and finished products conform to regulatory requirements (e.g., FDA, EMA).
• Regulatory Approvals: API suppliers should provide Certificates of Analysis (CoA), stability data, and batch documentation suitable for regulatory submissions.

Market Trends and Strategic Sourcing

The global demand for Metrolotion is driven by increasing prevalence of dermatological conditions and rising awareness. Countries such as India, China, and Brazil serve as critical manufacturing hubs, providing cost-effective raw materials and formulation capabilities.

Strategic sourcing involves multi-sourcing to reduce supply chain risks, vetting suppliers for quality assurance, and aligning procurement with regulatory pathways. Manufacturers often develop close partnerships with key suppliers to ensure steady supplies amid regulatory changes or raw material shortages.

Emerging Suppliers and Innovations

Innovation in API synthesis and excipient development allows suppliers to offer enhanced formulations with improved stability, bioavailability, and patient compliance.

Emerging suppliers focus on sustainable and green manufacturing practices, which are increasingly important for market access and regulatory approval.

Conclusion

Reliable supply of Metrolotion hinges on partnerships with high-quality API producers, excipient suppliers, and contract manufacturers adhering to global standards. Top API providers such as Sachez Chemicals, Han Hung Pharmaceutical, and Hubei Enyu Pharmaceutical play vital roles in the supply chain. Formulation expertise from companies like Perrigo and Recipharm ensures product quality and scalability.

Supply chain resilience, compliance with evolving regulations, and continuous innovation are key to maintaining market competitiveness and meeting global demand.

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Key Takeaways

• The core API supplier for Metrolotion predominantly includes Chinese and US-based companies offering GMP-compliant metronidazole.
• Excipient quality significantly influences product stability and efficacy; sourcing from established global suppliers is advisable.
• Contract manufacturing partners are critical for scaling production while maintaining regulatory compliance.
• Diversification of suppliers mitigates risks associated with raw material shortages and regulatory hurdles.
• Emphasis on sustainable and innovative manufacturing practices can provide competitive advantage.

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FAQs

1. Who are the leading suppliers of metronidazole API for Metrolotion?
Leading suppliers include Sachez Chemicals (US), Han Hung Pharmaceutical (China), and Hubei Enyu Pharmaceutical (China), all offering GMP-compliant APIs suitable for topical formulations.

2. What are the key regulatory considerations when sourcing raw materials for Metrolotion?
Suppliers must provide Certificates of Analysis, adhere to GMP standards, and sustain compliance with local and international regulatory bodies such as the FDA and EMA.

3. Can emerging markets provide competitive sourcing options for Metrolotion ingredients?
Yes. Countries like India and China offer cost-effective options with increasing compliance standards; however, due diligence on quality assurance is essential.

4. What role do excipient suppliers play in Metrolotion manufacturing?
They provide stabilizers, emulsifiers, preservatives, and viscosity agents critical for ensuring the topical formulation’s stability, efficacy, and patient acceptability.

5. How can pharmaceutical companies mitigate supply chain disruptions for Metrolotion?
By developing multi-sourcing strategies, forging long-term partnerships with verified suppliers, and maintaining sufficient inventory buffers aligned with regulatory requirements.

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References

[1] United States Pharmacopeia. USP Database and Monographs on metronidazole.
[2] European Pharmacopoeia. Monographs on topical pharmaceutical excipients.
[3] Market Research Future. Global Topical Drug Market Analysis 2022-2030.
[4] FDA Database. Approved APIs and manufacturing facilities.
[5] Industry Reports. "Top Suppliers of APIs in the Global Market," 2022.