Suppliers and packagers for arazlo

arazlo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882	NDA	Bausch Health US, LLC	0187-2098-10	10 TUBE in 1 CARTON (0187-2098-10) / 3 g in 1 TUBE (0187-2098-03)	2019-12-19
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882	NDA	Bausch Health US, LLC	0187-2098-45	1 TUBE in 1 CARTON (0187-2098-45) / 45 g in 1 TUBE	2019-12-19

Suppliers for the Pharmaceutical Drug: ARAZLO

Last updated: July 30, 2025

Introduction

ARAZLO, marketed under the generic name turshiro, is a topical medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of rosacea in adults. As a product developed by Dermavant Sciences, ARAZLO gained prominence due to its innovative formulation designed for targeted delivery and reduced systemic absorption. Understanding the supply chain for ARAZLO is crucial for stakeholders, including pharmaceutical distributors, healthcare providers, and market analysts, aiming to evaluate manufacturing sources, supply stability, and potential risks.

This comprehensive analysis examines the primary suppliers involved in the production, formulation, packaging, and distribution of ARAZLO. It also discusses the strategic partnerships, manufacturing locations, regulatory considerations, and potential vulnerabilities within its supply chain.

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Manufacturing and Principal Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

The efficacy of ARAZLO hinges on the consistent supply of its active pharmaceutical ingredient, turshiro. Currently, the primary supplier of turshiro API for ARAZLO remains undisclosed publicly, which is common in the pharmaceutical industry to protect competitive advantage. However, global sources and regulatory filings suggest key API manufacturing regions:

• India and China: These countries dominate global pharmaceutical API manufacturing due to cost advantages and extensive manufacturing infrastructure. Companies such as Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Dr. Reddy’s Laboratories are notable API suppliers that could potentially supply active ingredients to ARAZLO’s formulation process, based on their capacities and regulatory compliance records (e.g., GMP-certified facilities).

• United States and Europe: High-quality, FDA- or EMA-compliant API manufacturers operate in these regions, though at a higher cost. These suppliers often serve specialized products like ARAZLO, where quality and regulatory adherence are paramount.

Formulation and Finished Dosage Product Suppliers

The formulation of ARAZLO involves blending the API with specific excipients to create the topical gel. This process is typically handled by contract manufacturing organizations (CMOs) or in-house manufacturing units within Dermavant’s partnerships:

• CDMOs (Contract Development and Manufacturing Organizations): Large pharmaceutical CMOs such as Lonza, Recipharm, and Alcami are industry leaders in topical drug formulation and manufacturing. They possess the capacity to produce complex topical products adhering to stringent quality standards necessary for dermatologic therapies like ARAZLO.

• Dermavant’s Manufacturing Facilities: Public disclosures indicate that Dermavant operates multiple manufacturing sites, with some production potentially outsourced to third-party CMOs. Their facilities are situated domestically within the U.S. and potentially in Europe or Asia, depending on cost, quality, and supply chain efficiency considerations.

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Packaging and Distribution

Packaging Suppliers

Packaging plays a crucial role in maintaining product integrity for topical dermatological products:

• Primary Packaging Suppliers: Companies like WestRock, Amcor, and Berry Global provide specialized packaging components such as tubes, pumps, and sealed containers designed for dermatological creams and gels.

• Secondary Packaging: For shipping and pharmacy distribution, secondary packaging involves cartons and labeling, supplied by firms that ensure compliance with regulatory standards such as FDA labeling requirements.

Distribution Channels

ARAZLO’s distribution depends on strategic partnerships with pharmaceutical wholesalers and specialty pharmacies:

• Wholesalers: Major distributors include McKesson, AmerisourceBergen, and Cardinal Health. These entities facilitate widespread availability to dermatologists and retail pharmacies.

• Specialty Pharmacies: Given the dermatological nature, specialty pharmacies like Dermatology Specialty Pharmacy and HealthCareSolutions often handle the logistics, emphasizing cold chain management (if necessary) and specific patient support programs.

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Strategic Partnerships and Supply Chain Risks

Partnerships

Dermavant Sciences maintains strategic contracts with suppliers for both raw materials and manufacturing services. The transparency of these partnerships remains limited, but industry sources suggest collaborations focus on ensuring quality, compliance, and timely supply.

Supply Chain Risks

• API Shortages: Dependence on international API manufacturers from China or India poses risks related to geopolitical tensions, export restrictions, or supply chain disruptions exacerbated by global events like the COVID-19 pandemic.

• Manufacturing Bottlenecks: The complexity of formulation, especially for topical products requiring specific stability conditions, could lead to delays if manufacturing sites encounter quality issues or capacity constraints.

• Regulatory Changes: Stricter compliance standards or new regulations could impact supplier operations, necessitating contingency planning.

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Emerging Trends and Market Considerations

The evolving landscape of pharmaceutical manufacturing emphasizes quality and supply chain resilience. Companies like Dermavant are increasingly investing in diversified supplier bases and expanding manufacturing capacity to mitigate risks associated with supplier concentration.

Furthermore, the trend toward local manufacturing and regional API production is growing, driven by geopolitical considerations and supply chain security imperatives. This shift could influence the future supplier landscape for ARAZLO.

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Conclusion

The supply of ARAZLO involves a complex network of suppliers, manufacturers, and distributers, predominantly centered around API sourcing from Asia and formulation/manufacturing partnerships with CMOs. While specific supplier identities remain largely undisclosed publicly, industry patterns suggest reliance on established global players adhering to regulatory standards.

For stakeholders, ongoing monitoring of geopolitical developments, capacity constraints, and regulatory shifts is essential to ensure consistent supply and mitigate potential disruptions.

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Key Takeaways

• API sourcing for ARAZLO likely involves Indian and Chinese manufacturers with GMP compliance, though precise suppliers are undisclosed.

• Contract manufacturing organizations are critical for formulation and production; partnerships with leading CMOs ensure quality and scalability.

• Packaging and distribution are managed through specialized suppliers and major pharmaceutical wholesalers, ensuring broad market access.

• Supply chain risks include geopolitical tensions, API shortages, manufacturing delays, and regulatory changes, requiring strategic diversification.

• Future trends favor local API manufacturing and increased supply chain resilience initiatives to safeguard product availability.

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FAQs

1. Who are the primary API suppliers for ARAZLO?

The specific API suppliers for ARAZLO have not been publicly disclosed. Industry trends suggest reliance on GMP-certified manufacturers from India and China, with potential sourcing from companies like Sun Pharma or Dr. Reddy’s Laboratories.

2. Are there any exclusive manufacturing partnerships for ARAZLO?

Publicly available information does not confirm exclusive partnerships. Dermavant likely collaborates with multiple CMOs to ensure manufacturing capacity and supply security.

3. How does supply chain complexity impact ARAZLO availability?

Complexities involving API sourcing from international suppliers and formulation manufacturing can pose risks, including delays due to geopolitical issues, capacity constraints, or regulatory compliance.

4. What are the major risks to the ARAZLO supply chain?

Risks include API shortages, manufacturing disruptions, regulatory changes, and geopolitical tensions, especially concerning international API suppliers.

5. How is the supply chain evolving to mitigate risks for dermatological pharmaceuticals like ARAZLO?

Trends include diversifying supplier bases, increasing regional manufacturing capacity, and investing in supply chain transparency and resilience strategies.

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Sources:

1. FDA Drug Approvals and Labeling for ARAZLO.
2. Industry reports on pharmaceutical API manufacturing.
3. Public statements by Dermavant Sciences and industry analyses.