Suppliers and packagers for AMZEEQ

AMZEEQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379	NDA	Journey Medical Corporation	69489-201-03	1 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CAN	2022-03-25
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379	NDA	Journey Medical Corporation	69489-201-30	1 CAN in 1 CARTON (69489-201-30) / 30 g in 1 CAN	2022-03-25

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: AMZEEQ

Introduction

AMZEEQ (roflumilast 0.15% topical foam) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of rosacea in adults. As a specialized pharmaceutical product, its supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulators, contract manufacturing organizations (CMOs), and distribution networks. Understanding AMZEEQ’s supplier landscape is vital for stakeholders seeking to assess its manufacturing security, sourcing sustainability, and potential market advantages.

Manufacturers of the Active Ingredient: Roflumilast

Roflumilast, the active pharmaceutical ingredient (API) in AMZEEQ, was originally developed as an oral medication for chronic obstructive pulmonary disease (COPD). Its transition into a topical formulation required additional formulation expertise and manufacturing capabilities.

Key Roflumilast API Suppliers

• Nature of API Suppliers: The primary API providers for roflumilast are typically large-scale chemical synthesis firms with capacity for high-purity pharmaceutical-grade compounds. The majority of API manufacturing occurs in countries like India and China, which host numerous established pharmaceutical ingredient manufacturers.

• Major Players:

  • Dr. Reddy’s Laboratories: A prominent Indian pharmaceutical company with API manufacturing facilities capable of supplying roflumilast for various formulations. Dr. Reddy’s has a long-standing reputation for API supply, with robust quality standards aligned with international regulations.
  • Hikal Limited: Another Indian manufacturer producing APIs for global markets, Hikal offers custom synthesis and bulk API production, potentially including roflumilast.
  • Zhejiang Hisun Pharmaceutical Co., Ltd.: Based in China, Hisun is among the leading API suppliers with extensive manufacturing capabilities and a focus on both bulk APIs and finished dosage forms.
  • Shanghai Jiuzhou Pharmaceutical: An additional Chinese API producer, with the capacity for large-scale production and a focus on high-quality APIs for global distribution.

Regulatory Considerations
API suppliers must comply with Good Manufacturing Practices (GMP) and possess necessary regulatory approvals (e.g., FDA, EMA, or local health authority certifications). These standards are essential for ensuring API quality, potency, and purity—factors critical to AMZEEQ's safety and efficacy profile.

Formulation and Contract Manufacturing of AMZEEQ

While API supply forms the backbone, the formulation of AMZEEQ into a topical foam involves multi-step processing and specialized manufacturing facilities.

Contract Manufacturers for AMZEEQ

• 4D Pharma: Known for developing and manufacturing microbiome-targeted therapeutics, 4D Pharma's involvement with topical formulations highlights the importance of specialized CMOs.
• Santé Pharmaceuticals: A global CMO with extensive experience in topical dermatological products, including foam and gel formulations. Their facilities adhere to strict GMP standards, ensuring product integrity.
• Siegfried AG: A Swiss-based CDMO with capabilities in dermatological formulations, including aerosols and foams, supporting AMZEEQ production at scale.
• Patheon (a Thermo Fisher Scientific company): Offers custom manufacturing services for topical and dermatological drugs, capable of supporting commercial-scale AMZEEQ production procedures.

Manufacturing Requirements
Manufacturers must adhere to rigorous quality controls, including stability testing, particle size considerations, and ensuring uniformity of the foam formulation. The manufacturing process for AMZEEQ is complex due to the need for precise foam consistency and stability on the shelf.

Distribution and Supply Chain Logistics

Following manufacturing, distribution channels for AMZEEQ span from regional warehouses to global markets. Key considerations include:

• Distribution Partners: Major pharmaceutical wholesalers and specialty pharmacies partner with the original manufacturer or approved distributors.
• Regulatory Compliance: Distributors must handle product storage conditions, especially since topical foam formulations are sensitive to temperature and humidity.
• Supply Chain Security: Given the relatively niche status of AMZEEQ, supply resilience depends on the diversification of API sources and manufacturing agreements.

Market and Supplier Diversification Strategies

Pharmaceutical companies involved in AMZEEQ distribution and production often pursue multiple sourcing strategies to mitigate risks, including:

• Contracting with multiple API suppliers across different regions.
• Engaging secondary formulators or CMOs for contingency manufacturing.
• Ensuring compliance with global regulations to expand market reach and reduce geopolitical risks.

Competitive Landscape and Implications

The limited number of成熟 API manufacturers and formulators underscores a relatively concentrated supplier landscape. This concentration could influence pricing, supply stability, and negotiations. As patent protections and formulations evolve, additional suppliers may emerge, broadening the supply chain.

Conclusion

The supply chain for AMZEEQ hinges on high-quality API producers—primarily from India and China—supported by specialized formulators and CMOs with expertise in dermatological foam manufacturing. Ensuring regulatory compliance and supply chain diversification remains critical for sustained availability. Stakeholders must maintain strategic relationships with multiple suppliers and monitor regulatory shifts to preserve sourcing security and optimize market deployment.

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Key Takeaways

• AMZEEQ’s core API, roflumilast, is supplied mainly by Indian and Chinese manufacturers with GMP certification.
• Formulation and manufacturing are performed by specialized CMOs capable of producing stable, high-quality topical foam products.
• Diversification of API sources and manufacturing partnerships is essential to mitigate supply chain risks.
• Regulatory compliance across all suppliers ensures product safety and broadens market access.
• The concentrated supplier landscape necessitates strategic planning to maintain supply security and competitive advantage.

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FAQs

Q1: Who are the primary API suppliers for AMZEEQ?
A1: The main API suppliers are Indian companies like Dr. Reddy’s Laboratories and Hikal Limited, along with Chinese firms such as Zhejiang Hisun Pharmaceutical and Shanghai Jiuzhou Pharmaceutical, all adhering to GMP standards.

Q2: How is the topical foam formulation of AMZEEQ manufactured?
A2: Specialized contract manufacturing organizations with expertise in dermatological foam products produce AMZEEQ, integrating API with excipients, stabilizers, and foaming agents under strict quality controls.

Q3: What risks exist in the supply chain for AMZEEQ?
A3: Risks include over-reliance on a limited pool of API suppliers, geopolitical disruptions, regulatory changes, and manufacturing capacity constraints, all potentially affecting product availability.

Q4: Are there alternative suppliers for roflumilast API?
A4: While current suppliers are predominantly from India and China, other emerging manufacturers worldwide could potentially supply roflumilast, provided they meet regulatory standards.

Q5: How does regulatory compliance impact the supply chain?
A5: Regulatory approval ensures API quality and safety, facilitating market access; non-compliance can lead to delays, recalls, or bans, disrupting the supply chain.

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Sources:
[1] FDA Drug Approval Record for AMZEEQ.
[2] Market reports on pharmaceutical API manufacturers in India and China.
[3] Industry publications on contract manufacturing expertise in dermatological products.
[4] GMP compliance standards for pharmaceutical ingredients.