Suppliers and packagers for METROGEL

METROGEL

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	METROGEL	metronidazole	GEL;TOPICAL	021789	NDA	Galderma Laboratories, L.P.	0299-3820-60	60 g in 1 TUBE (0299-3820-60)	2005-06-30
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-936-61	60 g in 1 TUBE (66993-936-61)	2005-06-30
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-663-55	1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMP	2023-11-10

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: METROGEL

Introduction

METROGEL is a pharmaceutical formulation primarily recognized for its topical use, primarily composed of a controlled-release hydrogel system. It is utilized in therapeutic applications ranging from dermatology to wound care, depending on its specific active ingredient and formulation purpose. With increasing demand driven by the expanding skincare and wound management markets, a comprehensive understanding of suppliers involved in METROGEL’s supply chain is crucial for stakeholders including manufacturers, distributors, and healthcare providers.

Understanding METROGEL: Composition and Market Application

METROGEL formulations typically integrate active pharmaceutical ingredients (APIs) within a hydrogel base, providing sustained drug delivery, ease of application, and enhanced patient compliance. Its market applications include treatment of inflammatory skin conditions, wound healing, and localized pain management. The production of METROGEL involves multiple raw materials, including polymers, APIs, stabilizers, preservatives, and solvent systems, each supplied by specialized vendors.

Key Raw Material Suppliers for METROGEL Production

1. Polymers and Hydrogel Base Components
The backbone of METROGEL is often a synthetic polymer such as carbomer, polyvinyl alcohol, or sodium hyaluronate. These polymers confer the hydrogel properties—moisture retention, adhesiveness, and controlled release capabilities.

• BASF SE: A global leader in polymers, supplying carbomer-based products widely used in hydrogel formulations [1].
• Kemira: Offers a range of water-soluble polymers suitable for pharmaceutical hydrogels, including polyvinyl alcohol and other grades tailored for biomedical applications [2].
• FMC Biopolymers (a division of Ingredion): Specializes in natural polymers such as sodium hyaluronate, widely used in soft tissue and skincare hydrogel formulations [3].

2. Active Pharmaceutical Ingredients (APIs)
The core therapeutic agent’s source significantly influences METROGEL’s efficacy. Suppliers vary depending on the API but often include established bulk API manufacturers:

• Sigma-Aldrich (Merck Group): Supplies a broad spectrum of APIs, including anti-inflammatory and analgesic compounds often incorporated into METROGEL formulations [4].
• Lonza: Known for high-quality APIs suitable for dermatological and wound healing products, such as corticosteroids or antibiotics [5].
• Fagron: Specializes in custom compounded APIs and excipients tailored for topical formulations including METROGEL prep.

3. Additives, Stabilizers, and Preservatives
Additive components enhance stability, shelf-life, and usability. Suppliers include:

• Abbott Laboratories: Provides preservatives like parabens compatible with hydrogel systems [6].
• BASF: Supplies stabilizers, antioxidants, and emulsifiers utilized to augment formula stability.

Contract Manufacturing and Formulation Service Providers

In some cases, pharmaceutical companies outsource the formulation and manufacturing of METROGEL to Contract Development and Manufacturing Organizations (CDMOs). These organizations often source raw materials from the aforementioned suppliers. Notable CDMOs include:

• Recipharm: Offers topical formulations with in-house raw material sourcing and formulation expertise.
• Catalent: Provides comprehensive contract manufacturing services for topical hydrogels, leveraging a global supply chain for raw materials.

Regulatory and Quality Considerations

Suppliers for METROGEL components must comply with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards such as USP, Ph. Eur., or JP. This ensures consistent quality, safety, and efficacy of the products supplied. Vendors like BASF and Sigma-Aldrich maintain certifications and conduct rigorous quality control testing, critical for pharmaceutical use.

Supply Chain Dynamics and Risks

The availability and stability of raw material supplies underpin the consistent manufacture of METROGEL. Disruptions in polymer supply chains, geopolitical issues affecting raw material sourcing, or regulatory changes can impact production timelines. Diversifying suppliers and fostering relationships with multiple vendors mitigate such risks. Additionally, the adoption of alternative or synthetic polymers may further diversify sourcing options.

Emerging Trends and Future Outlook

Advances in biocompatible polymers, natural hydrogel components, and sustainability-focused sourcing are shaping the future of METROGEL supply chains. Suppliers investing in eco-friendly, bio-based raw materials—such as plant-derived polymers—align with evolving regulatory and consumer preferences. Increased collaborations between pharmaceutical companies and raw material suppliers are expected to streamline supply logistics and ensure supply chain resilience.

Conclusion

The supply chain for METROGEL hinges on a robust network of polymer providers, API manufacturers, additive suppliers, and contract manufacturers. Leading global firms such as BASF, Sigma-Aldrich, and Kemira dominate sourcing of core hydrogel components, whereas specialized API suppliers like Lonza and Fagron underpin therapeutic efficacy. Navigating supply chain risks involves diversification, quality assurance, and staying abreast of technological innovations.

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Key Takeaways

• Diverse Supplier Base: METROGEL’s production relies on polymers, APIs, and additives from established global suppliers to ensure quality and supply continuity.
• Quality and Compliance: Suppliers’ adherence to cGMP and pharmacopeial standards is crucial for regulatory approval and patient safety.
• Supply Chain Risks: Political, logistical, or material shortages can disrupt production; diversifying sources mitigates these risks.
• Emerging Trends: Bio-based polymers and sustainability initiatives are gaining traction among raw material suppliers.
• Strategic Partnerships: Building reliable relationships with reputable vendors ensures consistent supply for manufacturing ongoing demand.

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FAQs

Q1: Who are the major polymer suppliers for METROGEL formulations?
A1: Companies like BASF, Kemira, and FMC Biopolymers are prominent suppliers providing carbomers, polyvinyl alcohol, and natural polymers like sodium hyaluronate used in METROGEL formulations.

Q2: What considerations are critical when sourcing APIs for METROGEL?
A2: Ensuring high purity, batch-to-batch consistency, regulatory compliance, and a reliable supply chain are key when sourcing APIs from manufacturers such as Sigma-Aldrich, Lonza, or Fagron.

Q3: How do supply chain disruptions impact METROGEL production?
A3: Disruptions can cause delays, increased costs, or formulation shortages. Diversification of suppliers and establishing long-term agreements mitigate these risks.

Q4: Are there alternatives to synthetic polymers in METROGEL formulations?
A4: Yes. Natural and bio-based polymers such as sodium hyaluronate, alginates, and cellulose derivatives are increasingly used to meet sustainability goals.

Q5: What role do contract manufacturing organizations play in METROGEL supply?
A5: CDMOs handle formulation development, production, and packaging, sourcing raw materials per specifications to ensure quality and scalability for commercialization.

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References

1. [BASF SE] (2022). Polymer solutions for pharmaceutical hydrogels.
2. [Kemira] (2023). Water-soluble polymers for biomedical applications.
3. [FMC Biopolymers] (2022). Natural polymers for healthcare products.
4. [Sigma-Aldrich/Merck] (2023). APIs for topical dermatology and wound care.
5. [Lonza] (2022). Pharmaceutical-grade APIs for skincare.
6. [Abbott Laboratories] (2023). Preservatives and stabilizers in pharmaceutical formulations.