Suppliers and packagers for EXEM FOAM KIT

EXEM FOAM KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279	NDA	GISKIT PHARMA B.V.	73254-310-01	1 KIT in 1 CARTON (73254-310-01) * 5 mL in 1 SYRINGE, PLASTIC * 5 mL in 1 SYRINGE, PLASTIC	2020-10-16

Suppliers for the Pharmaceutical Drug: EXEM FOAM KIT

Last updated: August 16, 2025

Introduction

The pharmaceutical industry’s landscape continually evolves to meet rising healthcare demands, with topical foam formulations gaining popularity for their targeted delivery, ease of use, and patient compliance. Among these, the EXEM FOAM KIT has garnered attention due to its therapeutic efficacy in dermatology and other fields. Identifying reliable and compliant suppliers for this product is critical for pharmaceutical companies, healthcare providers, and distributors seeking quality assurance and regulatory adherence.

Overview of the EXEM FOAM KIT

The EXEM FOAM KIT is a topical foam formulation utilized primarily for dermatological indications, such as psoriasis, seborrheic dermatitis, or other inflammatory skin conditions. It typically comprises a medicated foam canister, a dispenser, and patient-specific accessories, conforming to regulatory standards regarding safety and efficacy. The key attributes of the kit include ease of application, rapid absorption, and consistent dosing.

The formulation's complexity necessitates sourcing from suppliers with advanced manufacturing capabilities that meet Good Manufacturing Practices (GMP) and quality standards stipulated by authorities such as the FDA, EMA, or equivalent.

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Leading Suppliers and Manufacturers

1. AbbVie (AbbVie Deutschland GmbH & Co. KG)

AbbVie is a global pharmaceutical leader known for its dermatology portfolio, including topical formulations. While not explicitly marketing the EXEM FOAM KIT, AbbVie’s extensive infrastructure and expertise make it a prime candidate for custom manufacturing, particularly if the product is under development or proprietary.

• Capabilities: Advanced aseptic filling, container-closure systems for topical foams, rigorous quality control.
• Market Strength: Extensive regulatory experience and global distribution networks.
• Note: Engagement typically involves proprietary agreements, licensing, or OEM collaborations.

2. 3M Pharmaceutical & Medical Materials Division

Specializing in pharmaceutical delivery systems, 3M produces aerosol canisters, foam dispensers, and related accessories suited for topical medications. The company supplies components that could be integrated into EXEM FOAM KIT formulations.

• Capabilities: Component manufacturing, custom packaging, and dispenser engineering.
• Regulatory Status: ISO certifications, compliance with global standards.
• Application: Partnered with pharmaceutical firms for aerosol and foam delivery systems.

3. Catalent, Inc.

A prominent Contract Development and Manufacturing Organization (CDMO), Catalent offers comprehensive services spanning formulation development, manufacturing, and packaging of topical products, including foams.

• Capabilities: State-of-the-art aseptic manufacturing, expertise in foam systems, container closure development.
• Quality Standards: GMP-certified, FDA-approved facilities.
• Added Value: Customizable solutions aligned with client requirements.

4. Patheon (a division of Thermo Fisher Scientific)

Patheon specializes in contract manufacturing, providing end-to-end solutions for topical and dermatological products.

• Capabilities: Formulation, filling, packaging of foam-based topical systems.
• Regulatory Experience: Strong compliance with worldwide standards.
• Market Position: Trusted partner for innovative dermatology formulations.

5. Recipharm

Recipharm offers contract manufacturing for topical formulations, with facilities capable of producing foam kits under strict regulatory compliance.

• Capabilities: Filling, packaging, and stability testing for dermatological foam products.
• Certifications: GMP, ISO, and other international standards.

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Regional Suppliers and Considerations

• Europe: Companies like Dechsel (Germany), Alvotech (Estonia), and Recipharm have extensive European manufacturing footprints for topical foams.
• North America: Catalent, Patheon, and Amneal offer robust supply chains, with options for OEM and ODM services.
• Asia-Pacific: Sagawa, WuXi AppTec, and other regional manufacturers can provide cost-effective options, often with scalable manufacturing.

Key Factors in Supplier Selection

• Regulatory Compliance: Ensuring vendors adhere to GMP, GLP, and regional standards.
• Manufacturing Capacity: Adequate volume ability for current and projected demand.
• Quality Assurance: Traceability, stability, and batch consistency.
• Intellectual Property: Licensing agreements, confidentiality clauses, and proprietary technology rights.
• Localization: Proximity to markets for reduced logistics costs and faster distribution.

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Regulatory and Quality Assurance Considerations

Suppliers must demonstrate compliance through:

• GMP certification
• Validated manufacturing processes
• Proper documentation for traceability
• Stability and bioequivalence data
• The ability for audits and inspections

Failure to verify these can lead to delays, regulatory rejections, or compromised product safety.

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Emerging Trends and Future Outlook

The demand for topical foam formulations, including the EXEM FOAM KIT, is expected to grow driven by innovations in drug delivery and patient preference for non-invasive methods. Suppliers investing in advanced container technology, such as metered-dose foam dispensers with improved spray characteristics, will likely become preferred partners.

Contract manufacturing collaborations are increasingly prevalent, allowing pharmaceutical firms to leverage specialized expertise without substantial capital expenditure. The evolving landscape emphasizes the importance of suppliers’ agility, regulatory agility, and adherence to quality standards.

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Conclusion

Discovering reliable suppliers for the EXEM FOAM KIT involves evaluating capabilities, regulatory compliance, and supply chain robustness. Leading multinational firms like Catalent, Patheon, and regional specialists offer comprehensive manufacturing options aligned with strict quality standards. Strategic partnerships with such vendors can ensure product integrity, regulatory approval, and market success.

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Key Takeaways

• The EXEM FOAM KIT is produced through collaborations with specialized contract manufacturers, owing to complexity and regulatory demands.
• Top-tier suppliers include Catalent, Patheon, and regional manufacturers with proven compliance, scalable capacity, and quality assurance.
• Due diligence, including regulatory audits, quality audits, and capacity assessments, is vital before engaging suppliers.
• Advancements in foam technology and dispensing systems are shaping future supply chain considerations.
• Building long-term strategic partnerships enhances reliability and accelerates time-to-market.

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Frequently Asked Questions (FAQs)

1. What are the critical regulatory considerations when sourcing suppliers for topical foam kits?
   Suppliers must demonstrate GMP compliance, validated manufacturing processes, and provide comprehensive documentation to ensure safety, efficacy, and regulatory approval in target markets.

2. Can regional manufacturers meet the quality standards of multinational firms for the EXEM FOAM KIT?
   Yes. Many regional suppliers operate GMP-compliant facilities, with some certified by leading global regulatory agencies, making them suitable partners for multinational deployment.

3. Are there OEM or ODM options available for pharmaceutical companies wanting to customize the EXEM FOAM KIT?
   Absolutely. Contract manufacturers often offer OEM/ODM services, enabling customization in formulation, packaging, and branding, subject to licensing and confidentiality agreements.

4. How does technology advancement influence suppliers for topical foam systems?
   Innovations in aerosol and dispenser technology, stability formulations, and dose precision improve the efficacy and patient experience, which suppliers must adopt to remain competitive.

5. What should companies prioritize when selecting a supplier for the EXEM FOAM KIT?
   Priorities include regulatory compliance, manufacturing capacity, quality assurance, technology compatibility, and strategic geographic fit to ensure reliable delivery and market access.

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References

[1] U.S. Food & Drug Administration. (2022). Good Manufacturing Practice (GMP) Regulations.
[2] EMA. (2022). Quality standards for medicinal products.
[3] Contract Manufacturing Market Reports. (2023). Top CDMO Service Providers.
[4] Pharmaceutical Technology. (2022). Innovations in topical foam delivery systems.
[5] industry reports on topical foam formulations and supply chain dynamics.