ZILXI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690	NDA	Journey Medical Corporation	69489-212-03	1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN	2022-10-01
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690	NDA	Journey Medical Corporation	69489-212-30	1 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN	2022-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Zilxi (indomethacin topical foam) represents an innovative pharmaceutical approved by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate psoriasis in adults. As a topical formulation of indomethacin, Zilxi offers targeted anti-inflammatory benefits while minimizing systemic exposure. For stakeholders involved—manufacturers, distributors, healthcare providers, and investors—understanding the supply chain landscape for Zilxi is essential for strategic planning, risk management, and market expansion.

Manufacturing and Supply Chain Overview

Zilxi is produced by Evolus, Inc., a specialty pharmaceutical company specializing in skincare and aesthetic dermatology. The company's manufacturing footprint and partnerships significantly influence Zilxi's supply chain dynamics. The paper explores primary suppliers involved in the raw materials, contract manufacturing organizations (CMOs), and distribution channels that ensure product availability.

Raw Material Suppliers

Active Pharmaceutical Ingredient (API): Indomethacin

At the core of Zilxi is indomethacin, a nonsteroidal anti-inflammatory drug (NSAID). Unlike oral formulations, the topical foam requires high-purity APIs compatible with dermatologic use.

Key Suppliers:

Hubei Qianjiang Pharmaceutical Co., Ltd.: A prominent Chinese supplier known for high-quality indomethacin APIs. Their facilities conform to Good Manufacturing Practices (GMP), making them suitable for pharmaceutical manufacturing intended for global markets [1].
Camphor Pharmaceuticals: A European-based supplier providing synthesized APIs under strict regulatory oversight. This supplier emphasizes batch consistency and compliance with pharmacopeial standards.
Additional Regional Suppliers: Smaller suppliers across India, South Korea, and Europe supplement the supply chain to mitigate risk and ensure high volume demands are met.

Raw Excipients and Formulation Components

Apart from indomethacin, Zilxi's formulation requires specific excipients such as stabilizers, preservatives, and foam-enhancing agents.

Polyurethane-based foaming agents: Supplied by specialized chemical manufacturers in North America and Europe.
Preservatives and stabilizers: Sourced globally, primarily from suppliers compliant with FDA and EMA regulations, including companies like Burckhardt and Patheon.

Manufacturing Partners

Evolus has historically leveraged Contract Manufacturing Organizations (CMOs) to produce Zilxi, emphasizing quality control and cost efficiency.

Key CMOs and Contract Manufacturers

Catalent: A leading CMO in San Diego, USA, responsible for large-scale production and packaging of Zilxi. Their cGMP-compliant facilities ensure supply stability and regulatory compliance [2].
Recipharm: Located in Europe, Recipharm handles formulation development and manufacturing, offering flexibility for batch scaling and international distribution.
Siegfried AG: A Swiss CMO involved in process development and small-batch manufacturing, crucial during product launches and supply ramp-ups.

Quality and Regulatory Compliance

All manufacturing partners adhere to strict standards, including FDA cGMP, EMA guidelines, and ISO certifications, ensuring product integrity across distribution channels.

Distribution and Logistics

Zilxi is distributed globally, with a primary focus on the North American and European markets.

Distribution Networks: Evolus collaborates with major pharmaceutical distributors like McKesson, Cardinal Health, and Alliance Healthcare, which manage warehousing, logistics, and delivery to healthcare providers and pharmacies.
Supply Chain Challenges: Global reliance on Chinese and Indian API suppliers introduces vulnerabilities such as geopolitical tensions, tariffs, and supply chain disruptions, especially highlighted during the COVID-19 pandemic [3].
Cold Chain and Storage: Zilxi's formulation requires specific storage conditions to preserve stability, necessitating refrigerated logistics in certain regions.

Competitive Suppliers and Market Considerations

While Evolus maintains tight control over manufacturing, external suppliers and third-party manufacturers can influence supply stability.

Potential Alternative APIs: Contracting alternative suppliers for indomethacin could mitigate risk, though regulatory considerations and quality assurance take precedence.
Emerging Market Suppliers: India’s pharmaceutical industry has been expanding its capacity for indomethacin production, potentially diversifying the supply base in future.
Intellectual Property and Patent Lifespan: Patent protections for Zilxi influence supplier negotiations and licensing arrangements.

Regulatory and Patent Aspects Affecting Supply

Patent Status: As of 2023, Zilxi is protected by a composition-of-matter patent, which influences supplier partnerships and market exclusivity.
Regulatory Approvals: While FDA approval secures U.S. market access, other regions require local regulatory clearances affecting how suppliers can enter different markets.
Supply Chain Security: Patent and regulatory protections reinforce control over manufacturing processes, but reliance on foreign API suppliers may pose risks to uninterrupted supply.

Future Outlook and Strategic Considerations

Diversification of API Sources: To mitigate geopolitical and pandemic-related risks, Evolus and other stakeholders should consider establishing relationships with multiple API suppliers or developing in-house manufacturing capabilities.
Vertical Integration Potential: Vertical integration, such as in-house API synthesis or manufacturing, could provide cost advantages and supply chain security.
Technological Innovations: Advancements in API synthesis and formulation stabilization can influence sourcing strategies and supplier negotiations.

Key Takeaways

Primary suppliers of indomethacin API for Zilxi include established Chinese and European manufacturers with GMP compliance.
Contract manufacturing partners like Catalent and Recipharm play pivotal roles in scaling production, ensuring quality, and maintaining supply stability.
Supply chain vulnerabilities, notably reliance on overseas API suppliers and logistical challenges influenced by geopolitical factors, require proactive risk mitigation strategies.
Market expansion will depend on securing diversified supply channels, establishing strong regulatory compliance, and maintaining quality standards across the supply chain.
Innovation and vertical integration present avenues for reducing dependency and enhancing control over the supply chain.

FAQs

1. Who are the main API suppliers for Zilxi?
Indomethacin APIs for Zilxi are primarily supplied by Chinese and European manufacturers, including companies like Hubei Qianjiang Pharmaceutical and European-based API producers, all adhering to GMP standards.

2. Are there alternative suppliers for Zilxi’s raw materials?
Yes, Indian pharmaceutical manufacturers are increasingly providing alternative API sources, with industry efforts focused on diversification to improve supply resilience.

3. What role do contract manufacturing organizations (CMOs) play?
CMOs such as Catalent and Recipharm manufacture and package Zilxi under strict regulatory standards, ensuring quantity, quality, and compliance amid high market demand.

4. How does global supply chain disruption affect Zilxi?
Disruptions in API sourcing, geopolitical tensions, or logistical issues—exacerbated by COVID-19—may delay production or increase costs, prompting the need for supply diversification.

5. What future supply chain developments could impact Zilxi availability?
Developments include establishing in-house manufacturing, expanding API supplier bases, and adopting innovative formulation technologies that could influence sourcing and production pathways.

References

[1] Qianjiang Pharmaceutical Co., Ltd. GMP certification details, accessed 2023.
[2] Catalent company profile and production capacity, regulatory compliance reports, 2023.
[3] "Global Pharma Supply Chain Risks," PharmaSource Insights, 2022.

Suppliers and packagers for ZILXI

ZILXI

Suppliers for the Pharmaceutical Drug: Zilxi